↑ 疾患リストへ ← 戻る

 299. 嚢胞性線維症 [臨床試験数:856,薬物数:981(DrugBank:220),標的遺伝子数:84,標的パスウェイ数:158] 

Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03931252February 202011 November 2019Thermic Effect of Feeding in Cystic FibrosisThermic Effect of Feeding in Cystic FibrosisCystic FibrosisDietary Supplement: Boost VHC;Dietary Supplement: Ensure High ProteinVirginia Commonwealth UniversityRecruiting18 YearsN/AAll10N/AUnited States
2NCT03698448December 1, 201922 October 2019A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic FibrosisA Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic FibrosisCystic FibrosisDrug: OligoG Dry powder for inhalationAlgiPharma ASImperial College London;Cystic Fibrosis Foundation;European Cystic Fibrosis Society;University Hospital of CologneNot recruiting12 YearsN/AAll120Phase 2/Phase 3Germany
3NCT02547116December 20199 September 2019Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic FibrosisEpidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic FibrosisCystic Fibrosis;MRSADrug: RifampinJohns Hopkins UniversityNot recruiting12 YearsN/AAll16Phase 4United States
4NCT03058068December 201915 July 2019Human MesenchymAl Stem Cells Infusion in Patients With Cystic FibrosisA Phase I, Randomized and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis - HAPICystic FibrosisBiological: Allo-hMSCs;Biological: PlaceboJoshua M HareNot recruiting20 Years45 YearsAll18Phase 1United States
5NCT03921060December 20197 October 2019Markers of Osteoporosis in Cystic FibrosisMarkers of Osteoporosis in Cystic FibrosisCystic FibrosisDrug: DenosumabUniversity of Texas Southwestern Medical CenterNot recruiting12 Years64 YearsAll100Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04058366November 201930 September 2019Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)Cystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll250Phase 3
7NCT04135495October 16, 20194 November 2019A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X AlleleA Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients With Cystic Fibrosis With at Least One G542X AlleleCystic FibrosisDrug: ELX-02Eloxx Pharmaceuticals, Inc.Recruiting18 YearsN/AAll8Phase 2United States
8NCT03435939October 15, 20197 October 2019Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240Anti-Inflammatory Therapy to Augment CFTR Rescue in CF PatientsCystic FibrosisDrug: LosartanUniversity of Kansas Medical CenterNot recruiting18 YearsN/AAll16Early Phase 1United States
9NCT04105972October 3, 201911 November 2019A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508delA Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508delCystic FibrosisDrug: ELX/TEZ/IVA;Drug: TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedRecruiting12 YearsN/AAll158Phase 3Australia;Belgium;Germany;United Kingdom
10NCT04126473October 3, 20194 November 2019A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X AlleleA Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients With Cystic Fibrosis With at Least One G542X AlleleGenetic Disease;Nonsense Mutation;Cystic Fibrosis With Meconium IleusDrug: ELX-02Eloxx Pharmaceuticals, Inc.Recruiting16 YearsN/AAll16Phase 2Israel
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03924947October 2, 20194 November 2019A Study to Compare US Marketed Pancrelipase Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis.A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site, in Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Cystic FibrosisCystic FibrosisDrug: PancrelipaseAbbVieRecruiting12 YearsN/AAll28Phase 4United States;Spain
12NCT03925194October 1, 20196 May 2019A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CFA Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic FibrosisCystic Fibrosis, 10011762Drug: AnakinraHeidelberg UniversityNot recruiting12 YearsN/AAll52Phase 2Germany
13NCT04090294October 1, 201914 October 2019Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis BronchiectasisAssessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis BronchiectasisBronchiectasisDrug: RoflumilastAssiut UniversityNot recruiting18 Years75 YearsAll35Early Phase 1
14NCT04118010October 201922 October 2019Vitamin D and Prebiotics for Intestinal Health in Cystic FibrosisVitamin D and Prebiotics for Intestinal Health in Cystic FibrosisCystic Fibrosis;DysbiosisDrug: Vitamin D3;Drug: Placebo vitamin D3;Drug: Inulin;Drug: Placebo InulinEmory UniversityNot recruiting18 YearsN/AAll40Phase 4United States
15NCT04059094September 16, 201911 November 2019A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® InhalerA Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic FibrosisCystic FibrosisDrug: BI 1265162;Drug: PlaceboBoehringer IngelheimRecruiting12 YearsN/AAll98Phase 2United States;Belgium;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04038710September 5, 20194 November 2019Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.An Observational Study of the Effects on Clinical Outcomes of Expanded Access Program of Vertex Triple Combination Therapy.Cystic FibrosisDrug: Triple combination therapyNational Jewish HealthRecruiting12 YearsN/AAll7Phase 2United States
17NCT04039087September 5, 20194 November 2019Sildenafil Exercise: Role of PDE5 InhibitionMechanisms of Exercise Intolerance in Cystic Fibrosis: Role of PDE5 InhibitionCystic FibrosisDrug: Sildenafil 40mg oral capsule;Drug: Placebo Oral capsuleNational Jewish HealthAugusta University;Cystic Fibrosis FoundationRecruiting9 YearsN/AAll40Phase 2/Phase 3United States
18NCT04056702September 5, 20194 November 2019Impact of Triple Combination CFTR Therapy on Sinus Disease.Impact of Elexacaftor-tezacaftor-ivacaftor Triple Combination CFTR Therapy on Sinus Disease: Quantitative Sinus Computed Tomography, Patient Reported Outcomes and Cellular and Molecular ChangesCystic FibrosisDrug: Elexacaftor-tezacaftor-ivacaftor exposureJennifer Taylor-CousarCystic Fibrosis FoundationRecruiting18 Years89 YearsAll70Phase 4United States
19NCT03506061September 4, 201930 September 2019Symdeko in Cystic Fibrosis PatientsiPS Cell Response to CFTR Modulators: Study of Symdeko in CF Patients Carrying Partial Function MutationsCystic FibrosisDrug: SymdekoEmory UniversityNational Heart, Lung, and Blood Institute (NHLBI)Recruiting12 YearsN/AAll22Phase 2United States
20NCT04006873September 3, 20194 November 2019Gut Imaging for Function & Transit in Cystic Fibrosis Study 2A Randomised Crossover Pilot Study of the Effects of Tezacaftor/Ivacaftor and Ivacaftor on Gastrointestinal Function Using Magnetic Resonance Imaging Parameters in People With Cystic FibrosisCystic FibrosisDrug: Tezacaftor/Ivacaftor + Ivacaftor;Drug: Placebo oral tabletNottingham University Hospitals NHS TrustVertex Pharmaceuticals Incorporated;Cystic Fibrosis Foundation;Cystic Fibrosis Trust;University of Nottingham;Nottingham University Hospitals CharityRecruiting12 Years40 YearsAll12Phase 2United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04058353August 28, 20194 November 2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)Cystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVA;Drug: TEZ/IVAVertex Pharmaceuticals IncorporatedRecruiting12 YearsN/AAll250Phase 3United States
22NCT03969888August 27, 201911 June 2019A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del MutationCystic FibrosisDrug: ABBV-3067;Drug: Placebo ABBV-3067;Drug: ABBV-2222;Drug: Placebo ABBV-2222AbbVieNot recruiting18 YearsN/AAll189Phase 2United States
23NCT04043806August 9, 201911 November 2019A Study Evaluating the Long-term Safety of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic FibrosisCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedRecruiting12 YearsN/AAll480Phase 3United States
24NCT03587961August 1, 201914 October 2019Personalized Theratyping TrialPersonalized Theratyping TrialCystic FibrosisDrug: SymdekoUniversity of Alabama at BirminghamRecruiting6 YearsN/AAll20Early Phase 1United States
25NCT04058340July 30, 20192 September 2019Taste Receptors Regulation in CF PatientsThe Effects of Taste Receptors Regulation in Upper Airway Innate Immunity of CF PatientsCystic FibrosisDietary Supplement: lactizole nebulization;Other: PlaceboMedical Universtity of LodzRecruiting6 YearsN/AAll30N/APoland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03988816July 20191 July 2019Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis.Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis: a Cross-over, Unicentric, Double-blind and Placebo-controlled StudyBronchiectasis AdultDrug: Roflumilast;Drug: Placebo oral tabletUniversity of Sao Paulo General HospitalRecruiting18 YearsN/AAll30Phase 2Brazil
27NCT03597347June 20, 201930 September 2019Trial of Inhaled Molgramostim in CF Subjects With NTM InfectionAn Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) InfectionMycobacterium Infections, Nontuberculous;Cystic Fibrosis (CF)Drug: Molgramostim nebulizer solution;Device: PARI eFlow nebulizer systemSavara Inc.Recruiting18 YearsN/AAll30Phase 2United States
28NCT03734744June 17, 201926 August 2019PK/PD of Vitamin D3 in Adults With CFA Pilot Study Evaluating Single, High-dose Pharmacokinetics/Pharmacodynamics of Vitamin D3 in CFVitamin D Deficiency;Cystic FibrosisDietary Supplement: Vitamin D3University of Southern CaliforniaRecruiting18 YearsN/AAll12N/AUnited States
29NCT03485456May 29, 201926 August 2019DPI-Tobra-Kind Cyclops® in Children With Cystic FibrosisPharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin Via the Cyclops® in Children With Cystic FibrosisCystic FibrosisDrug: TobramycinUniversity Medical Center GroningenRecruiting6 Years18 YearsAll10Phase 1/Phase 2Netherlands
30NCT04010799May 27, 201915 July 2019A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) BronchiectasisA Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Patients Affected by Cystic Fibrosis and Non Cystic Fibrosis BronchiectasisCystic Fibrosis;Non-Cystic Fibrosis BronchiectasisDrug: CHF 6333;Drug: PlaceboChiesi Farmaceutici S.p.A.Recruiting18 YearsN/AAll48Phase 1Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03965832May 24, 201915 July 2019HFNT During Exercise in CFA Pilot Study to Evaluate the Feasibility of Using High-flow Nasal Therapy During Exercise in Patients With Cystic Fibrosis and Severe Lung DiseaseCystic FibrosisDevice: HFNT during exercise;Device: Standard oxygen therapy/RAThe Leeds Teaching Hospitals NHS TrustRecruiting18 YearsN/AAll20N/AUnited Kingdom
32NCT03822455May 15, 201929 July 2019A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic FibrosisA Phase 2b Randomised, Double-blind, Parallel-group Study of Alginate Oligosaccharide (OligoG) Dry Powder Inhalation in Addition to Standard of Care Compared to Placebo in Addition to Standard of Care in Patients With Cystic Fibrosis (CF)Cystic FibrosisDrug: OligoG DPIAlgiPharma ASAlgiPharma Australia Pty. Ltd.Recruiting18 YearsN/AAll33Phase 2/Phase 3Australia
33NCT02748798May 201923 April 2019Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung DisordersDeveloping Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung DisordersLung Transplant;Lung Resection;Lung Cancer;Asthma;Cystic Fibrosis;Chronic Obstructive Pulmonary Disease;Emphysema;Mesothelioma;Asbestosis;Pulmonary Embolism;Interstitial Lung Disease;Pulmonary Fibrosis;Bronchiectasis;Seasonal Allergies;Cold Virus;Lung Infection;Pulmonary Hypertension;Pulmonary Dysplasia;Obstructive Sleep ApneaDrug: HP 3He;Drug: HP 129Xe;Drug: PFP;Drug: SF6;Device: 129Xe Small and Large Human Lung Coil;Device: 3He Human Lung Coil;Device: PFP and SF6 Human Lung CoilThunder Bay Regional Research InstituteThunder Bay Regional Health Sciences Centre;St. Joseph's Care Group;Lakehead UniversityNot recruiting18 YearsN/AAll160Early Phase 1Canada
34NCT03903913May 201923 April 2019Safety, Tolerability and Efficacy of S-1226 in Cystic FibrosisA Phase IIa Open Label Study to Evaluate the Safety, Tolerability and Efficacy of S-1226 Administered by Nebulization in Subjects With Mild to Moderate Cystic FibrosisCystic FibrosisDrug: S-1226SolAeroMed Inc.Recruiting14 Years50 YearsAll12Phase 2Canada
35NCT03912233April 30, 201922 October 2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: VX-121;Drug: TEZ;Drug: VX-561;Drug: TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll87Phase 2United States;Germany;Netherlands;Portugal;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT03911713April 17, 20194 November 2019A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: VX-561;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedRecruiting18 YearsN/AAll88Phase 2United States;Australia;Belgium;Germany;Ireland;United Kingdom
37NCT03795363April 10, 20197 October 2019Orkambi Treatment in 2 to 5 Year Old Children With CFNutritional Impact of Orkambi Treatment in 2 to 5 Year Old Children Homozygous for F508del MutationsCystic FibrosisDrug: OrkambiChildren's Hospital of PhiladelphiaVertex Pharmaceuticals IncorporatedRecruiting2 Years5 YearsAll32Phase 2United States
38NCT03870841April 3, 201926 August 2019The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic FibrosisAn Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus InfectionAspergillosis;Cystic FibrosisDrug: PC945Pulmocide LtdRecruiting18 YearsN/AAll18Phase 2United Kingdom
39NCT03710538April 1, 201917 June 2019The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic FibrosisThe Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic FibrosisCystic FibrosisDietary Supplement: Snack beverage;Behavioral: ExerciseInstitut de Recherches Cliniques de MontrealRecruiting18 YearsN/AAll14N/ACanada
40NCT03724955April 201929 April 2019Pilot E2 for Hypogonadal Women With CFBDPilot Study Evaluating the Effects of Estradiol for Hypogonadal Women With Cystic Fibrosis and OsteopeniaCystic Fibrosis Related Bone DiseaseDrug: Estradiol 2 mg;Other: PlaceboEmory UniversityNot recruiting18 YearsN/AFemale0Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03894657April 20198 April 2019Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®.Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®. Pathway to Personalized Therapy in Cystic FibrosisCystic Fibrosis;Homozygous F508del MutationDiagnostic Test: Nasal brushing;Other: Sputum sample;Other: blood sample;Drug: OrkambiAssistance Publique - Hôpitaux de ParisNot recruiting12 YearsN/AAll104N/AFrance
42EUCTR2018-003831-31-HU28/03/201930 April 2019MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis.A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs - MS1819/18/02Exocrine Pancreatic Insufficiency
MedDRA version: 20.0 Level: LLT Classification code 10033628 Term: Pancreatic insufficiency System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MS1819-SD
Pharmaceutical Form: Capsule, hard
AzurRxAuthorised Female: yes
Male: yes
24Phase 2Hungary
43NCT03902236March 1, 201915 April 2019Reaction Time and Postural Control in Individuals With Cystic Fibrosis and BronchiectasisEvaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and BronchiectasisCystic Fibrosis;BronchiectasisOther: Reaction Time and Postural Control;Other: Muscle oxygenation;Other: Exercise capacity;Other: BalanceHacettepe UniversityRecruiting6 Years18 YearsAll60N/ATurkey
44NCT03632525February 22, 201929 April 2019Intravenous Iron in Adults With Cystic FibrosisA Pilot Trial of Intravenous Iron for the Treatment of Iron Deficiency in Adult Patients With Cystic FibrosisCystic Fibrosis;Iron-deficiencyDrug: Ferric carboxymaltoseUniversity of OxfordRecruiting18 YearsN/AAll20Phase 4United Kingdom
45NCT03783286February 6, 20197 October 2019Ivacaftor Treatment in 6 Month to 2 Year Old CF SubjectsNutritional Impact of Ivacaftor Treatment in 6 Month to 2 Year Old Children With CF Gating MutationsCystic FibrosisDrug: IvacaftorChildren's Hospital of PhiladelphiaVertex Pharmaceuticals IncorporatedRecruiting1 Year2 YearsAll18Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03746483January 10, 201920 May 2019OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisA Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819-SD in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisExocrine Pancreatic Insufficiency (EPI);Cystic Fibrosis (CF)Drug: MS1819-SD;Drug: Porcine PERTAzurRx BioPharma, Inc.Recruiting18 YearsN/AAll30Phase 2United States;Poland
47NCT03647228December 13, 20182 September 2019A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic FibrosisA Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION-827359, an Antisense Oligonucleotide Inhibitor of ENaC, Administered to Healthy Volunteers and Patients With Cystic FibrosisHealthy Subjects;Cystic FibrosisDrug: IONIS-ENaCRx;Drug: PlaceboIonis Pharmaceuticals, Inc.Recruiting18 Years50 YearsAll88Phase 1United Kingdom
48NCT03669614December 7, 201826 August 2019SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis SubjectsA P1/2a Randomized, Double-Blind, Two-Part, Dose-Ascending, Multicenter Study of the Safety and PK of AR-501 (Gallium Citrate), Administered Via Inhalation, in Healthy Adult and P. Aeruginosa Infected Cystic Fibrosis SubjectsCystic FibrosisDrug: inhaled AR-501;Drug: inhaled AR-501 placeboAridis Pharmaceuticals, Inc.Recruiting18 Years49 YearsAll96Phase 1/Phase 2United States
49NCT02323100December 2, 201829 July 2019Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)A Double Blind, Placebo Controlled, Dose Escalation Trial of Glycerol Phenylbutyrate Corrector Therapy for Cystic FibrosisCystic FibrosisDrug: Ravicti low dose;Drug: Ravicti high dose;Drug: PlaceboNational Jewish HealthUniversity of Alabama at Birmingham;Children's Hospital of Philadelphia;Johns Hopkins University;Horizon Pharma Ireland, Ltd., Dublin IrelandRecruiting18 YearsN/AAll36Phase 1/Phase 2United States
50NCT03624101December 1, 201827 May 2019Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsNovel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsCystic FibrosisDrug: Tezacaftor/IvacaftorUniversity of Alabama at BirminghamRecruiting18 YearsN/AAll5Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03756922November 27, 201826 August 2019A DDI Study of FDL169 and FDL176 in Healthy SubjectsA Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: FDL169;Drug: FDL176Flatley Discovery Lab LLCRecruiting18 Years55 YearsAll78Phase 1/Phase 2United Kingdom
52EUCTR2017-003723-29-DE19/11/201826 November 2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic FibrosisCystic Fibrosis (CF)
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Corbus Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
415Phase 2Serbia;Portugal;United States;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
53NCT03748199November 8, 20183 December 2018Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CFPhase-Ib/IIa Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Inhaled Multiple Doses of POL6014 in Patients With Cystic FibrosisCystic FibrosisDrug: POL6014;Drug: PlaceboSanthera PharmaceuticalsRecruiting18 Years55 YearsAll40Phase 1/Phase 2Germany
54NCT03617718November 1, 201821 January 2019Project 2 Airway Potential Hydrogen (pH) in AsthmaMethods to Identify and Treat Severe Asthma Patients Project 2: Airway pH PhenotypingCystic Fibrosis;Asthma;Severe Persistent Asthma;HealthyDrug: Glycine BufferUniversity Hospitals Cleveland Medical CenterNational Institutes of Health (NIH)Recruiting18 Years50 YearsAll75Phase 1/Phase 2United States
55EUCTR2018-000185-11-CZ15/10/201828 February 2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC
Product Code: VX-445/TEZ/IVA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VX-445
CAS Number: 2216712-66-0
Current Sponsor code: VX-445
Other descriptive name: VX-445
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Tezacaftor
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
460Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03265288October 10, 201830 September 2019Study of LAU-7b in the Treatment of Cystic Fibrosis in AdultsAPPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in AdultsCystic FibrosisDrug: LAU-7b;Drug: Placebo oral capsuleLaurent Pharmaceuticals Inc.Cystic Fibrosis FoundationRecruiting18 YearsN/AAll136Phase 2United States;Canada
57NCT03525574October 9, 201830 September 2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationCystic FibrosisDrug: VX-445;Drug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll507Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom
58NCT03691779October 2, 201811 November 2019Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of AgeA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of AgeCystic FibrosisDrug: VX-445;Drug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedRecruiting6 Years11 YearsAll56Phase 3United States;Australia
59NCT03956589October 1, 20183 June 2019Functional Respiratory Imaging and Orkambi in CFFunctional Respiratory Imaging (FRI) to Assess the Short-term Effect of the Product ORKAMBI (Lumacaftor/ Ivacaftor) on Lung Function in ORKAMBInaive Patients With Cystic Fibrosis Homozygous for Phe508delCystic FibrosisDrug: OrkambiUniversity Hospital, AntwerpRecruiting12 YearsN/AAll20Phase 4Belgium
60EUCTR2018-002579-16-SE26/08/20183 September 2018Measurement of the posaconazole concentration in exhaled breath in CF patients after a single dose posaconazole to correlate to the concentration in blood and saliva.Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus spp. related lung-disease. Part 1. Pharmacokinetic single center study.Cystic Fibrosis (CF) is the most common life–limiting autosomal recessive disease among people of European heritage. The condition is a result of a mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene on chromosome seven, which encodes a chloride channel. In the lung defective channel activity leads to thick, viscous secretion and impaired mucociliary clearance. This causes trapping of mucus, colonization with bacteria and fungi, and a persistent inflammatory response.
MedDRA version: 20.0 Level: PT Classification code 10074549 Term: Cystic fibrosis respiratory infection suppression System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Noxafil®
Pharmaceutical Form: Tablet
Karolinska University Hospital, Stockholm CF centerAuthorisedFemale: yes
Male: yes
12Phase 2Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03591094August 21, 201829 April 2019Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic FibrosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect of PTI-428 in Subjects With Cystic FibrosisCystic FibrosisDrug: PTI-428;Drug: PlaceboProteostasis Therapeutics, Inc.Not recruiting18 YearsN/AAll40Phase 2United States
62NCT03551691August 7, 201825 March 2019PPIs and Fat Absorption in CF and EPIProton Pump Inhibitors and Fat Absorption in Subjects With Cystic Fibrosis and Pancreatic InsufficiencyPancreatic Insufficiency;Cystic FibrosisDrug: Omeprazole 40mg Capsule;Drug: Placebo oral capsuleChildren's Hospital of PhiladelphiaChiesi USARecruiting12 YearsN/AAll24Phase 2United States
63NCT03525548August 3, 201818 March 2019A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)Cystic FibrosisDrug: VX-445;Drug: TEZ;Drug: IVA;Drug: TEZ/IVAVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll113Phase 3United States;Belgium;Netherlands;United Kingdom
64NCT03633526August 3, 20182 September 2019Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of AgeA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-659/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of AgeCystic FibrosisDrug: VX-659;Drug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNot recruiting6 Years11 YearsAll18Phase 3United States
65NCT03655249August 1, 201830 September 2019Effects of AD on VI in Patients With CFEffects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic FibrosisCystic FibrosisOther: Autogenic drainage;Drug: AerosoltherapyCliniques universitaires Saint-Luc- Université Catholique de LouvainRecruiting6 YearsN/AAll30N/ABelgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03593434July 30, 201820 August 2018Airway Clearance Therapy on Hyperpolarized 129Xenon and MRIThe Effect of Airway Clearance Therapy on Hyperpolarized 129Xenon MRI Compared With Lung Clearance Index and Spirometry in Cystic FibrosisCystic FibrosisDrug: hyperpolarized Xenon gasChildren's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)Recruiting6 Years21 YearsAll20Phase 2United States
67NCT03447262July 13, 201818 March 2019A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination TherapyA Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationCystic FibrosisDrug: VX-659;Drug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll484Phase 3United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom
68NCT03565692July 1, 201818 December 2018Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-IvacaftorLum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-IvacaftorCystic FibrosisBiological: the lung mycobiota and microbiota profile;Biological: the gut mycobiota and microbiota profileUniversity Hospital, BordeauxSociété Française de la MucoviscidoseRecruiting6 YearsN/AAll250Phase 1France
69EUCTR2017-003761-99-DE27/06/201814 January 2019A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delAn Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
Pharmaceutical Form: Granules
INN or Proposed INN: LUMACAFTOR
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Other descriptive name: LUMACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Granules
Route of administration of the placebo: Oral use
Product Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
Pharmaceutical Form: Granules
INN or Proposed INN: LUMACAFTOR
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Other descriptive name: LUMACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 188-
Pharmaceutical form of the placebo: Granules
Route of administration of the placebo: Oral use
Trade Name: Orkambi 100 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LUMACAFTOR
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Other descriptive name: LUMACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Other descriptive name: IVACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
50Phase 2Germany
70EUCTR2016-004479-35-BE26/06/201828 February 2019A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Vertex Pharmaceuticals IncorporatedNot Recruiting Female: yes
Male: yes
65Phase 3France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2017-002968-40-BE26/06/20187 January 2019A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6 to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX661
Other descriptive name: VRT-893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
72NCT03525444June 15, 201830 September 2019A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: VX-445;Drug: TEZ;Drug: IVA;Drug: Matched PlacebosVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll405Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom
73EUCTR2018-001573-24-BE11/06/201827 August 2018Evaluation of the short-term effect of ORKAMBI on lung function in patients with cystic fibrosis who have two copies of the F508del mutation using functional respiratory imagingFunctional Respiratory Imaging (FRI) to assess the short-term effect of the product ORKAMBI (lumacaftor/ ivacaftor) on lung function in ORKAMBI-naive patients with Cystic Fibrosis Homozygous for Phe508del.Cystic Fibrosis Homozygous (homozygous for the F508del mutation)
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Orkambi
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Antwerp University HospitalAuthorisedFemale: yes
Male: yes
20Phase 4Belgium
74EUCTR2017-003723-29-SE07/06/201828 February 2019A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic FibrosisCystic Fibrosis (CF)
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENABASUM
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENABASUM
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Corbus Pharmaceuticals, Inc.Authorised Female: yes
Male: yes
415Phase 2Serbia;Portugal;United States;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
75EUCTR2017-003319-21-GB04/06/201830 April 2019Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisCystic fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: None
CAS Number: Not assigned
Current Sponsor code: PTI-808
Other descriptive name: PTI-808
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-150
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: None
CAS Number: Not assigned
Current Sponsor code: PTI-801
Other descriptive name: PTI-801
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 50-100
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: None
CAS Number: Not assigned
Current Sponsor code: PTI-428
Other descriptive name: PTI-428
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-100
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Proteostasis Therapeutics, Inc.Authorised Female: yes
Male: yes
240Phase 1;Phase 2France;United States;Canada;Belgium;Denmark;Germany;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03540524May 31, 201815 April 2019A Study Looking at the Safety, Tolerability and Efficacy of the Combination of the Study Drugs GLPG2451 and GLPG2222 With or Without GLPG2737 in Patients With Cystic Fibrosis.Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of the Combination of GLPG2451 and GLPG2222, With or Without GLPG2737, in Adult Subjects With Cystic FibrosisCystic FibrosisDrug: GLPG2451 dose regimen A;Drug: GLPG2451 dose regimen B;Drug: GLPG2222;Drug: GLPG2737Galapagos NVNot recruiting18 YearsN/AAll10Phase 1Belgium;Bulgaria;Germany;Greece;Netherlands;Serbia;Sweden;United Kingdom
77EUCTR2016-001440-18-NL30/05/201811 June 2018The influence of cytochrome P450 3A4 inhibitors on serum levels of Ivacaftor in cystic fibrosis patients and healthy subjects.Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls - IACIcystic fibrosis and healthy subjects;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Ivacaftor
Pharmaceutical Form: Film-coated tablet
Trade Name: claritromycin 500mg film coated tablets
Product Name: Claritromycin
Pharmaceutical Form: Film-coated tablet
Trade Name: Azithromycin 500 mg film-coated tablet
Product Name: azithromycin
Pharmaceutical Form: Film-coated tablet
Trade Name: Norvir 100 mg film-coated tablets
Product Name: Norvir
Pharmaceutical Form: Film-coated tablet
university medical center utrechtAuthorisedFemale: yes
Male: yes
12Phase 4Netherlands
78NCT03482960May 29, 201822 October 2019Comparison of 129Xe MRI With 19F MRI in CF Lung DiseaseComparison of 129Xe MRI With 19F MRI in CF Lung DiseaseCystic FibrosisDrug: Hyperpolarized Xenon gas;Drug: PFPUniversity of North Carolina, Chapel HillCystic Fibrosis FoundationNot recruiting18 YearsN/AAll8Early Phase 1United States
79NCT03462056May 17, 201815 July 2019Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic FibrosisPilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic FibrosisCystic FibrosisDietary Supplement: Cystic Fibrosis Ready to Use Supplemental FoodWashington University School of MedicineCystic Fibrosis FoundationNot recruiting2 Years12 YearsAll16Phase 1/Phase 2United States
80NCT03559062May 17, 201811 February 2019A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNot recruiting6 Years11 YearsAll69Phase 3Australia;Belgium;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT03375047May 10, 20181 April 2019Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic FibrosisA Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled, Combined Single and Multiple Ascending Dose Study Evaluating the Safety, Tolerability, and Biological Activity of MRT5005 Administered by Nebulization to Adult Subjects With Cystic FibrosisCystic FibrosisDrug: MRT5005;Drug: Normal salineTranslate Bio, Inc.Recruiting18 YearsN/AAll32Phase 1/Phase 2United States
82NCT03428334May 10, 201814 October 2019Roflumilast in Non-CF Bronchiectasis StudyA 4-week Single-arm Study of Roflumilast in Stable-state Non-cystic Fibrosis BronchiectasisNon-cystic Fibrosis BronchiectasisDrug: Oral roflumilastThe University of Hong KongNot recruiting18 YearsN/AAll20Phase 2Hong Kong
83NCT03460990May 1, 201818 December 2018A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)Cystic FibrosisDrug: VX-659;Drug: TEZ;Drug: IVA;Drug: TEZ/IVAVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll116Phase 3United States;Australia;Germany;Ireland;Spain;United Kingdom
84NCT03522831May 1, 20184 November 2019CF BronchodilationA Double-blind Placebo-controlled Crossover Study to Assess the Effects of Bronchodilation on Dyspnea, Ventilatory Responses, and Exercise Tolerance in Adults With Cystic FibrosisLung Diseases;Cystic FibrosisDrug: Salbutamol;Drug: PlaceboUniversity of British ColumbiaRecruiting19 YearsN/AAll20N/ACanada
85EUCTR2017-002968-40-IE27/04/201828 February 2019A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6 to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX661
Other descriptive name: VRT-893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
Vertex Pharmaceuticals IncorporatedAuthorised Female: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2017-004132-11-DE25/04/201828 February 2019A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VX-659
Current Sponsor code: VX-659
Other descriptive name: VX-659
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot Recruiting Female: yes
Male: yes
360Phase 3United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
87NCT03492567April 25, 20183 December 2018Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors.Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.Cystic FibrosisBiological: Blood testAssistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseNot recruiting18 YearsN/AAll25N/AFrance
88EUCTR2016-004479-35-DK18/04/201830 April 2019A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Vertex Pharmaceuticals IncorporatedNot Recruiting Female: yes
Male: yes
65Phase 3France;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland
89EUCTR2017-003723-29-HU16/04/201827 August 2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic FibrosisCystic Fibrosis (CF)
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Corbus Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
90NCT03527095April 5, 201812 November 2018A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy SubjectsA Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single DosesCystic FibrosisDrug: FDL169Flatley Discovery Lab LLCNot recruiting18 Years55 YearsAll11Phase 1United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT03489629April 3, 201826 August 2019STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)Cystic FibrosisDrug: Trimethoprim Sulfamethoxazole (TMP/SMX);Drug: Minocycline;Drug: Mupirocin;Drug: Chlorhexidine Gluconate;Behavioral: Environmental DecontaminationUniversity of North Carolina, Chapel HillUniversity of Washington;Cook Children's Medical Center;Indiana University;National Jewish Health;University of Michigan;University of Texas Southwestern Medical Center;St. Louis Children's HospitalRecruiting2 Years45 YearsAll42Phase 2United States
92NCT03768089March 19, 201811 June 2019Study of VX-121 in Healthy Subjects and in Subjects With Cystic FibrosisA Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic FibrosisCystic FibrosisDrug: VX-121;Drug: TEZ/IVA;Drug: IVA;Drug: Matched PlaceboVertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll114Phase 1/Phase 2Netherlands;United Kingdom
93EUCTR2018-000126-55-NL15/03/201821 May 2018A study to investigate the safety and the movement of the study drug VX- 121 around the body in healthy people and patients with cystic fibrosisA Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic FibrosisCystic fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Not yet assigned
Current Sponsor code: VX-121
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-720
Pharmaceutical form of the placebo: Powder for oral suspension
Route of administration of the placebo: Oral use
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
Current Sponsor code: VX-661
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
120Phase 1;Phase 2Netherlands
94NCT03447249March 7, 201818 March 2019A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: VX-659;Drug: TEZ;Drug: IVA;Drug: Matched PlacebosVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll385Phase 3United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom
95NCT03516331March 7, 201812 November 2018A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy SubjectsA Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy SubjectsCystic FibrosisDrug: FDL176 & FDL169 coadministrationFlatley Discovery Lab LLCNot recruiting18 Years55 YearsAll16Phase 1United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03367494March 1, 20188 April 2019A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide SensorA New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide SensorCystic FibrosisDiagnostic Test: Measurement of Sweat Chloride and Sweat BromideMilton S. Hershey Medical CenterRecruiting18 YearsN/AAll50N/AUnited States
97NCT03589313February 12, 201823 July 2018Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.Cystic FibrosisDrug: GLPG3067 single doseGalapagos NVNot recruiting18 YearsN/AMale6Phase 1Belgium
98NCT03421366February 5, 201812 February 2018Modified Release Posaconazole in Patients With Cystic FibrosisModified Release Posaconazole in Patients With Cystic FibrosisCystic FibrosisDrug: PosaconazoleBayside HealthNot recruiting18 YearsN/AAll20N/A
99NCT03500263January 30, 201830 September 2019Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic FibrosisA Phase 1 / 2, Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic FibrosisCystic FibrosisDrug: PTI-808;Drug: Placebo;Drug: PTI-801;Drug: PTI-428Proteostasis Therapeutics, Inc.Not recruiting18 YearsN/AAll12Phase 1/Phase 2United Kingdom
100NCT03460704January 29, 201811 June 2018Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS-2)A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 24 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa)Non Cystic Fibrosis BronchiectasisDrug: Colistimethate sodium;Drug: Saline SolutionZambon SpARecruiting18 Years90 YearsAll374Phase 3Poland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT02653027January 1, 201826 August 2019Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508delA Study of the Effect of Combination Lumacaftor and Ivacaftor on Glucose Tolerance in Persons With Cystic Fibrosis Who Are Homozygous for the Phe508del Cystic Fibrosis Transmembrane Conductance Regulator Mutation.Diabetes;Cystic FibrosisDrug: Lumacaftor-ivacaftor;Other: OGTTMassachusetts General HospitalNot recruiting18 Years65 YearsAll0N/A
102EUCTR2018-000185-11-DE28 February 2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC
Product Code: VX-445/TEZ/IVA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VX-445
CAS Number: 2216712-66-0
Current Sponsor code: VX-445
Other descriptive name: VX-445
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Tezacaftor
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Vertex Pharmaceuticals IncorporatedNot Available Female: yes
Male: yes
460Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
103EUCTR2018-000185-11-SE28 February 2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC
Product Code: VX-445/TEZ/IVA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VX-445
CAS Number: 2216712-66-0
Current Sponsor code: VX-445
Other descriptive name: VX-445
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Tezacaftor
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Vertex Pharmaceuticals IncorporatedNot Available Female: yes
Male: yes
460Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
104EUCTR2018-002624-16-FR28 February 2019NAValidation of respiratory epithelial functional assessment to predict clinical efficacy of Orkambi®. Pathway to personalized therapy in Cystic Fibrosis PREDICT-CF - PREDICT-CFHomozygous F508del patient aged 12 years or older
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi®
Product Name: Orkambi®
Pharmaceutical Form: Tablet
ASSISTANC-PUBLIQUE-HOPITAUX DE PARIS (AP-HP)Not Available Female: yes
Male: yes
104Phase 4France
105NCT03451045December 22, 201726 August 2019Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic FibrosisCystic FibrosisDrug: Lenabasum 20 mg;Drug: Lenabasum 5 mg;Other: PlaceboCorbus Pharmaceuticals Inc.Cystic Fibrosis FoundationRecruiting12 YearsN/AAll415Phase 2United States;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT03424252December 18, 201712 November 2018An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy SubjectsA Phase 1, Open-label, Crossover, Randomised Study to Evaluate the Pharmacokinetic Profile of FDL169 Sublingual Formulations in the Fed State in Healthy SubjectsCystic FibrosisDrug: FDL169Flatley Discovery Lab LLCNot recruiting18 Years55 YearsAll11Phase 1United Kingdom
107NCT03218917December 1, 201711 June 2019Assessment of INS1007 in Subjects With Non-Cystic Fibrosis BronchiectasisRandomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow StudyNon-Cystic Fibrosis BronchiectasisDrug: INS1007 10 mg oral tablet;Drug: INS1007 25 mg oral tablet;Drug: Placebo Oral TabletInsmed IncorporatedNot recruiting18 Years85 YearsAll240Phase 2United States;Australia;Belgium;Bulgaria;Denmark;Germany;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Singapore;Spain;United Kingdom;Sweden
108NCT03474042November 29, 201725 June 2018GLPG2737 on Top of Orkambi in Subjects With Cystic FibrosisA Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2737 in Orkambi-treated Subjects With Cystic Fibrosis Homozygous for the F508del MutationCystic FibrosisDrug: GLPG2737;Drug: PlaceboGalapagos NVNot recruiting18 YearsN/AAll22Phase 2Germany
109NCT03219164November 28, 201728 October 2019Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa InfectionRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/ColonizationPseudomonas Aeruginosa Respiratory Tract Infection;Cystic FibrosisDrug: AZLI;Drug: PlaceboGilead SciencesRecruiting3 Months18 YearsAll140Phase 3United States;Austria;Belgium;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Spain;United Kingdom
110EUCTR2016-005110-22-DE20/11/201725 June 2018A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic FibrosisPhase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic FibrosisCystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: POL6014
Pharmaceutical Form: Nebuliser solution
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Santhera Pharmaceuticals (Switzerland) LtdAuthorisedFemale: yes
Male: yes
40Phase 1;Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03206788November 11, 201726 August 2019Losartan and Inflammation in Cystic FibrosisLosartan as Anti-inflammatory Therapy to Augment F508del Cystic Fibrosis Transmembrane (CFTR) RecoveryCystic FibrosisDrug: Losartan;Drug: placeboUniversity of MiamiUniversity of Alabama at Birmingham;Children's Hospital Medical Center, Cincinnati;University of Kansas Medical CenterRecruiting12 YearsN/AAll36Phase 2United States
112EUCTR2017-002181-42-DE27/10/201723 July 2018GLPG2737 on top of Orkambi in subjects with cystic fibrosisA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del mutationCystic fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2737
Product Code: G1117337
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not applicable
Current Sponsor code: G1117337
Other descriptive name: GLPG2737
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Galapagos NVNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
113NCT03278314October 9, 201712 November 2018Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic FibrosisTezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic FibrosisCystic FibrosisDrug: tezacaftor/ivacaftorVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAllPhase 1/Phase 2
114EUCTR2017-000797-11-NL06/10/201730 April 2018A Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisCystic fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-445
Current Sponsor code: VX-445
Other descriptive name: VX-445
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: VX-445
Current Sponsor code: VX-445
Other descriptive name: VX-445
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tezacaftor
Current Sponsor code: VX-661
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
80Phase 2Netherlands;Australia;Belgium;United States
115NCT03309358September 28, 201711 June 2018A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic FibrosisA Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B)Lung Diseases;Pulmonary Disease;Cystic Fibrosis;Cystic Fibrosis Lung;Cystic Fibrosis Pulmonary Exacerbation;Cystic Fibrosis With Exacerbation;Respiratory Tract Disease;Pulmonary Inflammation;Multi-antibiotic Resistance;Antibiotic Resistant Infection;Lung Infection;Lung Infection Pseudomonal;Lung; Infection, Atypical Mycobacterium;Burkholderia Infections;Burkholderia Cepacia Infection;Lung InflammationDrug: Inhaled SNSP113;Drug: Inhaled PlaceboSynspira, Inc.Not recruiting18 Years50 YearsAll32Phase 1United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT03181932September 26, 20177 October 2019A Study of AeroVanc for the Treatment of MRSA Infection in CF PatientsA Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis PatientsMRSA;Cystic FibrosisDrug: Vancomycin inhalation powder;Drug: Placebo inhalation powderSavara Inc.Recruiting6 YearsN/AAll200Phase 3United States;Canada
117EUCTR2016-002749-42-DE22/09/201728 February 2019Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.1 Level: LLT Classification code 10068288 Term: Cystic fibrosis pulmonary exacerbation System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Pharmaceutical Form: Powder and solvent for nebuliser solution
INN or Proposed INN: AZTREONAM
Current Sponsor code: AZLI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Powder and solvent for nebuliser solution
Route of administration of the placebo: Inhalation use
Gilead Sciences, Inc.Authorised Female: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
118NCT02769637September 7, 20179 July 2018Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)Cystic FibrosisDrug: PPI treatmentUniversity of Colorado, DenverCystic Fibrosis Foundation TherapeuticsNot recruiting10 Years21 YearsAll2Phase 1United States
119NCT03771313September 1, 201718 December 2018Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic FibrosisPharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic FibrosisCystic FibrosisDrug: CeftarolineChildren's Hospital Medical Center, CincinnatiRecruiting2 Years21 YearsAll24Phase 4United States
120EUCTR2016-005230-30-PT28/08/201730 April 2019A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary EffectivenessCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SPX-101
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: SPX-101
Current Sponsor code: SPX-101
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Inhalation solution
Route of administration of the placebo: Inhalation use
Product Name: SPX-101
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: SPX-101
Current Sponsor code: SPX-101
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Inhalation solution
Route of administration of the placebo: Inhalation use
Spyryx Biosciences, Inc.Authorised Female: yes
Male: yes
90Phase 2France;Portugal;Canada;Australia;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2017-000797-11-BE28/08/20177 January 2019A Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisCystic fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-445
Current Sponsor code: VX-445
Other descriptive name: VX-445
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: VX-445
Current Sponsor code: VX-445
Other descriptive name: VX-445
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tezacaftor
Current Sponsor code: VX-661
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Tezacaftor
Product Code: VX-661
Pharmaceutical Form: Tablet
INN or Proposed INN: Tezacaftor (TEZ)
Current Sponsor code: VX-661
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Deuterated Ivacaftor
Product Code: VX-561 (CTP-656)
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-561
Current Sponsor code: VX-561
Other descriptive name: VX-561
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
104Phase 2United States;Belgium;Australia;Netherlands
122NCT03093714August 23, 201711 June 2018A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis SubjectsA Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics(PD) of FDL169 in Cystic Fibrosis (CF) Subjects Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: FDL169;Drug: PlaceboFlatley Discovery Lab LLCNot recruiting18 Years85 YearsAll27Phase 1Australia;Czechia;Germany;United Kingdom
123NCT03277196August 16, 20176 May 2019A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationA Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedRecruitingN/A24 MonthsAll75Phase 3United States;Australia;Canada;Germany;Ireland;United Kingdom
124EUCTR2016-004558-13-PL14/08/201730 April 2019A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS IINon-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 20.1 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: COLISTIMETHATE SODIUM
CAS Number: 8068-28-8
Other descriptive name: Colistimethate Sodium
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000000-
Pharmaceutical form of the placebo: Powder for nebuliser solution
Route of administration of the placebo: Inhalation use
Zambon S.p.A.Authorised Female: yes
Male: yes
420Phase 3France;United States;Canada;Argentina;Poland
125EUCTR2016-003585-11-GB10/08/201710 September 2018Study to Evaluate the Safety and Efficacy of VX-659 drug in combination with other drugs in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic FibrosisCystic fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659
Product Code: VX-659
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-659
Current Sponsor code: VX-659
Other descriptive name: VX-659
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Tezacaftor/Ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tezacaftor
Current Sponsor code: VX-661
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Tezacaftor
Product Code: VX-661
Pharmaceutical Form: Tablet
INN or Proposed INN: TEZACAFTOR
Current Sponsor code: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Deuterated Ivacaftor
Product Code: VX-561 (CTP-656)
Pharmaceutical Form: Tablet
INN or Proposed INN: Deuterated Ivacaftor
Other descriptive name: VX-561 (CTP-656)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
105Phase 2United States;Ireland;Israel;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT03172793August 8, 20174 November 2019Telavancin Pharmacokinetics in Cystic Fibrosis PatientsPharmacokinetics and Tolerability of Telavancin at Differing Dosing Regimens in Cystic Fibrosis Adults Admitted With Acute Pulmonary ExacerbationsCystic FibrosisDrug: Telavancin InjectionJoseph L. Kuti, PharmDCumberland Pharmaceuticals, Inc.Not recruiting18 YearsN/AAll18Phase 4United States
127NCT03224351August 8, 201711 March 2019A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: TEZ/IVA;Drug: VX-659;Drug: IVA;Drug: Matched Placebos;Drug: TEZ;Drug: VX-561Vertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll124Phase 2United States;Ireland;Israel;United Kingdom
128NCT03229252August 1, 20173 June 2019An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic FibrosisA Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)Cystic FibrosisDrug: Placebo Inhalation Solution;Drug: SPX-101Spyryx Biosciences, Inc.Not recruiting18 Years50 YearsAll91Phase 2Canada;France;Italy;Portugal;United Kingdom
129NCT03258424July 28, 201711 June 2018Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis on KALYDECO® as Background TherapyA Phase I, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmakinetics of PTI-428 in Subjects With Cystic Fibrosis.Cystic FibrosisDrug: PTI-428;Drug: PlaceboProteostasis Therapeutics, Inc.Recruiting18 YearsN/AAll16Phase 1United Kingdom
130EUCTR2016-001214-24-DE27/07/201726 March 2018A Multi-center, Randomized, Placebo-Controlled Phase I/II Study Designed to Assess the Safety, Tolerability, and how the body breaks down the drug PTI-428 in Subjects with Cystic FibrosisA Phase I/II Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects with Cystic Fibrosis - Proteostasis PTI428Cystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: PTI-428
Pharmaceutical Form: Capsule, hard
Current Sponsor code: PTI-428
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Code: PTI-428
Pharmaceutical Form: Capsule, hard
Current Sponsor code: PTI-428
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Proteostasis TherapeuticsNot RecruitingFemale: yes
Male: yes
132Phase 1;Phase 2France;United States;Czech Republic;Canada;Denmark;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT02819856July 21, 201725 March 2019SPI-1005 for Prevention and Treatment of Tobramycin Induced OtotoxicityA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for OtotoxicityOtotoxicityDrug: Placebo;Drug: SPI-1005 Ebselen 200mg Capsule x1;Drug: SPI-1005 Ebselen 200mg Capsule x2;Drug: SPI-1005 Ebselen 200mg Capsule x3Sound Pharmaceuticals, IncorporatedMedical University of South Carolina;Cystic Fibrosis FoundationRecruiting18 YearsN/AAll80Phase 2United States
132NCT03068312July 18, 201728 January 2019A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C?T or D1152H CFTR MutationA Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older and Have Either a 3849 + 10KB C?T or D1152H-CFTR MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNot recruiting6 YearsN/AAll38Phase 3Israel
133NCT03251092July 17, 201728 October 2019Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic FibrosisA Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults With Cystic FibrosisHealthy Volunteer - Complete;Cystic FibrosisDrug: PTI-808;Drug: Placebo;Drug: PTI-428;Drug: PTI-801Proteostasis Therapeutics, Inc.Recruiting18 Years99 YearsAll180Phase 1/Phase 2United States;Belgium;Canada;Denmark;France;Germany;New Zealand;United Kingdom
134EUCTR2016-001214-24-DK10/07/201730 April 2018A Multi-center, Randomized, Placebo-Controlled Phase I/II Study Designed to Assess the Safety, Tolerability, and how the body breaks down the drug PTI-428 in Subjects with Cystic FibrosisA Phase I/II Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects with Cystic Fibrosis - Proteostasis PTI428Cystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: PTI-428
Pharmaceutical Form: Capsule
Current Sponsor code: PTI-428
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Code: PTI-428
Pharmaceutical Form: Capsule
Current Sponsor code: PTI-428
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Code: PTI-428
Pharmaceutical Form: Capsule
Current Sponsor code: PTI-428
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Code: PTI-428
Pharmaceutical Form: Capsule
Current Sponsor code: PTI-428
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Proteostasis TherapeuticsNot RecruitingFemale: yes
Male: yes
144Phase 1;Phase 2France;United States;Czech Republic;Canada;Denmark;Germany;Italy;United Kingdom
135NCT03450720June 28, 201711 June 2018Pharmacokinetics of GLPG2737 in Male Subjects With Cystic FibrosisEvaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic FibrosisCystic FibrosisDrug: GLPG2737 single doseGalapagos NVNot recruiting18 YearsN/AMale6Phase 1Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT03173573June 27, 201717 September 2018A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF ParticipantsA Five Part Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Single and Repeat Oral Doses of FDL176 in Healthy and Cystic Fibrosis (CF) ParticipantsCystic FibrosisDrug: FDL176;Drug: PlaceboFlatley Discovery Lab LLCNot recruiting18 Years55 YearsAll109Phase 1Australia
137EUCTR2016-004033-25-ES19/06/20173 July 2017Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosisEfect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trialCystic Fibrosis
MedDRA version: 20.0 Level: LLT Classification code 10074550 Term: Preventive antimicrobial therapy in cystic fibrosis System Organ Class: 100000004865
MedDRA version: 20.0 Level: LLT Classification code 10011764 Term: Cystic fibrosis NOS System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Sodium bicarbonate
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sodium Bicarbonate
CAS Number: 144-55-8
Other descriptive name: SODIUM BICARBONATE BP
Concentration unit: mol/l mole(s)/litre
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Inhalation use
Product Name: sodium chloride
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Sodium chloride
CAS Number: 7647-14-5
Other descriptive name: SODIUM CHLORIDE
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentration number: 0.2-
Product Name: sodium chloride
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Sodium chloride
CAS Number: 7647-14-5
Other descriptive name: SODIUM CHLORIDE
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentration number: 0.2-
Product Name: Water for injections
Pharmaceutical Form: Solvent for parenteral use
INN or Proposed INN: water for injections
CAS Number: 7789-20-0
Other descriptive name: WATER FOR INJECTIONS, EP
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-
Fundació Parc TaulíAuthorisedFemale: yes
Male: yes
Phase 2Spain
138NCT03078088June 15, 201727 August 2018Airway Alkalinization and Nasal ColonizationAirway Alkalinization and Nasal ColonizationHealthy Subjects;Cystic FibrosisDrug: Tham;Drug: SalineLakshmi DurairajRecruiting16 YearsN/AAll64Phase 1United States
139NCT03020719June 14, 201727 August 2018The Role of Oral Glutathione on Growth Parameters in Children With Cystic FibrosisA Multi Center Placebo Controlled Double Blind Randomized Study Evaluating the Role of Oral Glutathione on Growth Parameters in Children With Cystic FibrosisCystic FibrosisDrug: Oral Glutathione;Drug: PlaceboUniversity of Minnesota - Clinical and Translational Science InstituteCystic Fibrosis Foundation TherapeuticsNot recruiting2 Years11 YearsAll60Phase 2United States
140NCT03066453June 13, 20174 March 2019Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic FibrosisEvaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.Cystic FibrosisDrug: Tobi Inhalant Product;Drug: NebcinUniversity Hospital, LilleRecruiting8 YearsN/AAll97Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03093974June 1, 201715 October 2018Long Term Efficacy and Safety of Inhaled Colistimethate Sodium in Bronchiectasis Subjects With Chronic Pseudomonas Aeruginosa Infection.A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa)Non Cystic Fibrosis BronchiectasisDrug: Colistimethate Sodium;Drug: Saline SolutionZambon SpARecruiting18 YearsN/AAll464Phase 3Belgium;Germany;Italy;Portugal;Spain;United Kingdom
142NCT03056989May 31, 201716 December 2017A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic FibrosisA Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic FibrosisCystic FibrosisDrug: SPX-101Spyryx Biosciences, Inc.Not recruiting18 Years50 YearsAll5Phase 1Canada
143EUCTR2016-004558-13-FR30/05/20172 October 2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS IINon-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 19.1 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: COLISTIMETHATE SODIUM
CAS Number: 8068-28-8
Other descriptive name: Colistimethate Sodium
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000000-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Zambon S.p.A.AuthorisedFemale: yes
Male: yes
264Phase 3United States;France;Canada;Poland
144NCT02950805May 30, 201723 July 2018A Study to Assess the Effect of AZD5634 on Mucociliary Clearance, Safety, Tolerability and Pharmacokinetic Parameters in Patients With Cystic FibrosisA Phase 1b Randomized Blinded Placebo-Controlled, Cross-Over Study to Assess the Effect of AZD5634 on Mucociliary Clearance as Well as Safety, Tolerability, and Pharmacokinetic Parameters Following Single Inhaled Dose Administration to Patients With Cystic Fibrosis.Pulmonary/Respiratory DiseasesDrug: Placebo;Drug: AZD5634AstraZenecaParexelNot recruiting18 Years60 YearsAll9Phase 1United States
145EUCTR2015-002743-33-DE29/05/201728 February 2019A clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS INon-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 20.1 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: COLISTIMETHATE SODIUM
CAS Number: 8068-28-8
Other descriptive name: Colistimethate Sodium
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000000-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Zambon S.p.A.Authorised Female: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Switzerland;United Kingdom;Italy;France;Belgium;Australia;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2016-004477-40-GB26/05/201730 April 2019A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutationCystic Fibrosis
MedDRA version: 19.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
Pharmaceutical Form: Tablet
INN or Proposed INN: Not applicable
Current Sponsor code: G957389
Other descriptive name: GLPG2222
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: GLPG2222
Product Code: G957389
Pharmaceutical Form: Tablet
INN or Proposed INN: Not applicable
Current Sponsor code: G957389
Other descriptive name: GLPG2222
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: GLPG2222
Product Code: G957389
Pharmaceutical Form: Tablet
INN or Proposed INN: Not applicable
Current Sponsor code: G957389
Other descriptive name: GLPG2222
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Galapagos NVNot Recruiting Female: yes
Male: yes
50Phase 2Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
147NCT03150719May 24, 201730 September 2019A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR MutationCystic FibrosisDrug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll98Phase 3United States;France;Germany
148NCT03125395May 12, 201726 August 2019A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: Lumacaftor;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNot recruiting2 YearsN/AAll57Phase 3United States;Canada
149EUCTR2016-004996-33-ES03/05/20173 July 2017A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del-CFTR MutationA Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR MutationCystic fibrosis subjects Homozygous for the F508del-CFTR Mutation
MedDRA version: 19.1 Level: SOC Classification code 10010331 Term: Congenital, familial and genetic disorders System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi
Product Name: Orkambi
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lumacaftor
Current Sponsor code: VX-809; VRT-826809; VRT-0826809
Other descriptive name: LUMACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200 -
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770, VRT-813077
Other descriptive name: IVACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125 -
Vertex Pharmaceuticals IncoporatedNot RecruitingFemale: yes
Male: yes
75Phase 4United Kingdom;Australia;Spain;Canada;United States
150NCT03070522May 1, 201715 July 2019Prednisone in Cystic Fibrosis Pulmonary ExacerbationsRandomized Controlled Trial of Prednisone in Cystic Fibrosis Pulmonary ExacerbationsCystic Fibrosis Pulmonary ExacerbationDrug: Prednisone;Drug: PlacebosThe Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationRecruitingN/AN/AAll84Phase 3Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT03051490April 28, 201711 June 2018RESULT: Reliable, Emergent Solution Using Liprotamase TreatmentA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Cystic FibrosisDrug: Liprotamase;Drug: porcine PERTAnthera PharmaceuticalsNot recruiting7 YearsN/AAll140Phase 3United States;Hungary;Israel;Lithuania;Poland;Spain;United Kingdom
152NCT03140527April 10, 201730 September 2019Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic FibrosisA Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic FibrosisHealthy Volunteer;Cystic FibrosisDrug: PTI-801;Drug: Placebo;Drug: PTI-808Proteostasis Therapeutics, Inc.Recruiting18 YearsN/AAll180Phase 1United States;Canada;Denmark;Germany
153NCT03104855April 3, 20176 May 2019Clearance of 25-hydroxyvitamin D in Cystic FibrosisClearance of 25-hydroxyvitamin D in Cystic FibrosisCystic FibrosisDrug: d6-25-hydroxyvitamin D3University of WashingtonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting18 YearsN/AAll10Phase 1United States
154NCT03584841March 31, 201722 July 2019Implementation of a Non-invasive Version of the Imaging ß-adrenergic-dependent Sweat Secretion TestImplementation of a Non-invasive Version of the Imaging ß-adrenergic-dependent Sweat Secretion Test: Value for Diagnosis and Efficacy of Target Therapies for Cystic FibrosisMucoviscidosis Involving the LungDiagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpineCliniques universitaires Saint-Luc- Université Catholique de LouvainRecruiting18 Years100 YearsAll120N/ABelgium
155EUCTR2016-001619-19-NL27/03/20178 May 2017Genistein as an add-on treatment for CF?Genistein as an add-on treatment for CF? -Cystic Fibrosis
;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Genistein
Pharmaceutical Form: Capsule
INN or Proposed INN: genistein
CAS Number: 446-72-0
Other descriptive name: GENISTEIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
UMC UtrechtAuthorisedFemale: yes
Male: yes
Phase 2Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT03119649March 18, 201716 December 2017A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic FibrosisA Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Multiple Doses of GLPG2222 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del MutationCystic FibrosisDrug: GLPG2222 dose 1 for cohort A;Drug: GLPG2222 dose 2 for cohort A;Drug: Placebo 1;Drug: GLPG2222 dose 1 for cohort B;Drug: GLPG2222 dose 2 for cohort B;Drug: Placebo 2Galapagos NVNot recruiting18 Years99 YearsAll59Phase 2United States;Belgium;Netherlands;Serbia;Spain;United Kingdom
157NCT03256799March 17, 201716 December 2017Evaluation of Ivacaftor in Patients Using Ataluren for Nonsense MutationsAn Open Label Study to Investigate the Role of Ivacaftor for the Treatment of Cystic Fibrosis in Combination With Ataluren (PTC124) in Cystic Fibrosis Patients Using Ataluren for Nonsense MutationsCystic FibrosisDrug: IvacaftorUniversity of Alabama at BirminghamNot recruiting19 YearsN/AAll1Phase 4United States
158NCT02950116March 9, 201716 December 2017Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung DiseaseLung Clearance Index in Pediatric Patients With Obstructive Lung DiseaseAsthma;Bronchiectasis;Cystic FibrosisDevice: Perform three multiple breath nitrogen washout tests (N2-MBW-test)Universitair Ziekenhuis BrusselNot recruiting6 Years17 YearsAll27N/ABelgium
159NCT02498535February 22, 20172 September 2019Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) PatientsProspective, Randomized, Placebo Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) PatientsCystic FibrosisDrug: Nitric Oxide 160 ppmNovoteris, LLCCystic Fibrosis Foundation;MallinckrodtRecruiting18 YearsN/AAll60Phase 2United States;Canada
160EUCTR2015-002743-33-GB21/02/201728 February 2019A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS INon-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 20.1 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: COLISTIMETHATE SODIUM
CAS Number: 8068-28-8
Other descriptive name: Colistimethate Sodium
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000000-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Zambon S.p.A.Authorised Female: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;United Kingdom;Switzerland;Italy;France;Belgium;Australia;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT02888730February 16, 201725 February 2019Tobramycin Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis PatientsEfficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double-blind Randomized Controlled TrialCystic Fibrosis;Rhinosinusitis;Lung DiseasesDrug: Tobramycin nebulized nasally;Drug: Physiologic serum nebulized nasallyVirginie ESCABASSEHenri Mondor University HospitalRecruiting7 YearsN/AAll86Phase 3France
162NCT02976519February 15, 201717 September 2018BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF SubjectsA Phase Ib, Multicentre, Double Blind, Randomized, Two-part Study, First Part Multiple Rising Dose and Second Part Two-way Cross-over, to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of BI 443651 Compared to Placebo Via Respimat® in Healthy Volunteers and CF Subjects.Cystic FibrosisDrug: Placebo;Drug: BI 443651Boehringer IngelheimNot recruiting18 Years55 YearsAll64Phase 1Germany;United Kingdom
163NCT02919995February 8, 201720 May 2019A Study of RPL554 in Patients With Cystic FibrosisA Phase IIa, Randomised, Double Blind, Placebo Controlled, Three Way Crossover Study to Assess the Pharmacokinetics of RPL554 Administered to Adult Patients With Cystic Fibrosis.Cystic FibrosisDrug: RPL554;Drug: PlaceboVerona Pharma plcCystic Fibrosis TrustNot recruiting18 YearsN/AAll10Phase 2United Kingdom
164NCT03256968January 27, 201728 January 2019PTC Study to Evaluate Ataluren in Combination With IvacaftorAn Open Label N of 1 Study to Evaluate the Study and Efficacy of Long-Term Treatment With Ivacaftor in Combination With Ataluren (PTC124) in Subjects With Nonsense Mutation Cystic FibrosisCystic FibrosisDrug: AtalurenUniversity of Alabama at BirminghamNot recruiting6 YearsN/AAll1Phase 4United States
165NCT03227471January 23, 20178 April 2019A Study of VX-445 in Healthy Subjects and Subjects With Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic FibrosisCystic FibrosisDrug: IVA;Drug: TEZ/IVA;Drug: VX-445;Drug: Matched Placebo;Drug: TEZ;Drug: VX-561Vertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll230Phase 1/Phase 2United States;Australia;Belgium;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2015-004986-99-IT11/01/201719 February 2018A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients with Cystic Fibrosis (CF) Being Treated for an Exacerbation of CF-associated Lung Disease.exacerbation of Cystic Fibrosis
MedDRA version: 19.0 Level: PT Classification code 10070608 Term: Infective pulmonary exacerbation of cystic fibrosis System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: cysteamine bitartrate
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
NovaBiotics, LtdAuthorisedFemale: yes
Male: yes
120Phase 2United States;Netherlands;United Kingdom;Italy
167EUCTR2016-000454-36-AT03/01/20179 October 2017A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic FibrosisCystic fibrosis
MedDRA version: 19.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tezacaftor
Current Sponsor code: VX-661
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Tezacaftor
Product Code: VX-661
Pharmaceutical Form: Tablet
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Australia;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
168NCT02955888January 3, 201712 March 2018Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose ToleranceA Phase 2, Double-Blind, Placebo Controlled Study to Evaluate the Safety & Tolerability of PBI-4050 and Its Effects on Pancreatic and Pulmonary Function in Cystic Fibrosis Patients With Abnormal Glucose ToleranceCystic FibrosisDrug: PBI4050;Drug: PlaceboProMetic Pharma SMT LimitedProMetic BioSciences Inc.Not recruiting18 YearsN/AAll11Phase 2Canada
169NCT02730793January 201715 July 2019Aztreonam Aerosol to Treat Cystic Fibrosis Nasal DiseaseAztreonam Aerosol to Treat Cystic Fibrosis Nasal DiseaseCystic FibrosisDrug: Oral Aztreonam;Drug: Nasal Aztreonam;Drug: Nasal PlaceboVirginia Commonwealth UniversityEastern Virginia Medical SchoolNot recruiting7 Years100 YearsAll30Phase 2United States
170NCT02894684January 201722 October 2019Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic FibrosisAztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous TherapyCystic Fibrosis;Infection;PseudomonasDrug: Aztreonam;Drug: Standard CareLiverpool Heart and Chest Hospital NHS Foundation TrustUniversity of LiverpoolNot recruiting16 Years65 YearsMale16Phase 4United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT02947126January 201719 November 2018Multilevel Models of Therapeutic Response in the LungsMultilevel Models of Therapeutic Response in the LungsCystic FibrosisDrug: Hypertonic Saline;Drug: Isotonic Saline;Drug: Indium-DTPA;Drug: Technetium Sulfur ColloidUniversity of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)Recruiting12 YearsN/AAll62N/AUnited States
172NCT03045523January 201716 December 2017A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic FibrosisA Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis Harbouring One F508del CFTR Mutation and a Second Gating (Class III) MutationCystic FibrosisDrug: GLPG2222 150 mg q.d.;Drug: GLPG2222 300 mg q.d.;Drug: PlaceboGalapagos NVNot recruiting18 Years99 YearsAll37Phase 2Australia;Belgium;Czechia;Germany;Ireland;United Kingdom
173EUCTR2017-001379-21-DE30 April 2019A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Vertex Pharmaceuticals IncorporatedNot Available Female: yes
Male: yes
75Phase 3United States;Canada;Ireland;Germany;United Kingdom
174EUCTR2017-001379-21-IE29 January 2018A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Vertex Pharmaceuticals IncorporatedNot AvailableFemale: yes
Male: yes
75Phase 3United States;Canada;Ireland;Germany;United Kingdom
175EUCTR2017-003723-29-FR28 February 2019A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic FibrosisCystic Fibrosis (CF)
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Corbus Pharmaceuticals, Inc.Not Available Female: yes
Male: yes
415Phase 2Serbia;Portugal;United States;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2016-001585-29-NL21/12/201629 January 2018Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR MutationCystic fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi 200 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LUMACAFTOR
Current Sponsor code: VX-809
Other descriptive name: LUMACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
20Phase 2Netherlands
177NCT03205904December 12, 201620 August 2018Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.Cystic Fibrosis-related Diabetes;Cystic FibrosisDietary Supplement: DietHospital de Clinicas de Porto AlegreRecruiting10 YearsN/AAll38N/ABrazil
178EUCTR2015-004263-36-GB07/12/20164 September 2017Study to assess the effects of inhaled RPL554 in adults with cystic fibrosis.A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis. - To assess the effects of inhaled RPL554 in adults with cystic fibrosisCystic Fibrosis (CF)
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: RPL554
Product Code: RPL554
Pharmaceutical Form: Nebuliser suspension
INN or Proposed INN: RPL554
CAS Number: 298680-25-8
Current Sponsor code: RPL554
Other descriptive name: RPL554
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 0.5-6
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Verona Pharma plcAuthorisedFemale: yes
Male: yes
10Phase 2United Kingdom
179EUCTR2016-002837-31-GB05/12/201628 February 2019A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutationCystic Fibrosis
MedDRA version: 19.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Not Applicable
Current Sponsor code: G957389
Other descriptive name: GLPG2222
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use
Product Name: GLPG2222
Product Code: G957389
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Not Applicable
Current Sponsor code: G957389
Other descriptive name: GLPG2222
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use
Galapagos NVNot Recruiting Female: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
180EUCTR2016-002837-31-IE02/12/201620 August 2018A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutationCystic Fibrosis
MedDRA version: 19.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Not Applicable
Current Sponsor code: G957389
Other descriptive name: GLPG2222
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use
Product Name: GLPG2222
Product Code: G957389
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Not Applicable
Current Sponsor code: G957389
Other descriptive name: GLPG2222
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use
Galapagos NVAuthorisedFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT02971839December 201627 August 2018Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating MutationsA Phase 2, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of CTP-656 With an Open-Label Active Comparator in Patients With Cystic Fibrosis With CFTR Gating Mutations.Cystic FibrosisDrug: CTP-656, 20 mg (QD);Drug: CTP-656, 100 mg (QD);Drug: CTP-656, 150 mg (QD);Drug: Placebo (QD);Drug: Kalydeco, 150 mg Tablet (BID; open-label)Vertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll11Phase 2United States
182NCT03000348December 20169 July 2018A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis ExacerbationsA Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients Being Treated for an Exacerbation of CF-associated Lung DiseaseCystic FibrosisDrug: Cysteamine;Drug: Placebo Oral CapsuleNovaBiotics Ltd.Agility Clinical, Inc.;PSR Group B.V.Not recruiting18 YearsN/AAll91Phase 2United States;Italy;United Kingdom
183NCT02759562November 4, 201620 August 2018Effect of Andecaliximab on FEV1 in Adults With Cystic FibrosisA Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic FibrosisCystic FibrosisDrug: Andecaliximab;Drug: PlaceboGilead SciencesNot recruiting18 YearsN/AAll6Phase 2Australia;France;Germany;Spain;United Kingdom;Belgium;Canada;Ireland;United States
184NCT02934698November 1, 201616 December 2017An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing MutationsAn Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing MutationsCystic FibrosisDrug: IvacaftorMedical University of South CarolinaVertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AFemale2Phase 3
185NCT02951195November 201621 January 2019A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic FibrosisA Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic FibrosisCystic FibrosisDrug: VX-152;Drug: Tezacaftor;Drug: Ivacaftor;Drug: Triple Placebo;Drug: Placebo for VX-152Vertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll80Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT03029455November 201616 December 2017A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic FibrosisA Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation, and Bioavailability Study Evaluating the Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Subjects With Cystic FibrosisCystic FibrosisDrug: VX-659;Drug: Tezacaftor;Drug: Ivacaftor;Drug: VX-659 Matching Placebo;Drug: Triple Combination (TC) Matching PlacebosVertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll163Phase 1United Kingdom
187NCT03056326November 201616 December 2017A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy SubjectsA Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male SubjectsNon-Cystic Fibrosis Bronchiectasis;Cystic FibrosisDrug: CHF6333 (Part 1 - SAD);Drug: Placebo (Part 1 - SAD);Drug: CHF6333 (Part 2 - MAD);Drug: Placebo (Part 2 - MAD)Chiesi Farmaceutici S.p.A.Not recruiting18 Years55 YearsMale72Phase 1Belgium
188EUCTR2015-004986-99-GB31/10/20163 April 2017A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients with Cystic Fibrosis (CF) Being Treated for an Exacerbation of CF-associated Lung Disease.exacerbation of Cystic Fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: cysteamine bitartrate
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
NovaBiotics, LtdAuthorisedFemale: yes
Male: yes
120Phase 2United States;Netherlands;Italy;United Kingdom
189NCT02677701October 21, 201611 June 2019Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With CFTEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A Randomized, Placebo-controlled, Double-blinded Trial of Azithromycin 500mg Thrice Weekly in Combination With Inhaled TobramycinCystic FibrosisDrug: azithromycin;Drug: placebo (for azithromycin);Drug: inhaled tobramycinSeattle Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating CenterRecruiting12 YearsN/AAll140Phase 4United States
190NCT02912637October 201611 February 2019Hyperpolarized Xenon Imaging in Patients With Cystic FibrosisHyperpolarised 129Xe MRI for Non-invasive Assessment of Ventilation, Perfusion and the Alveolar Membrane - a Physiological Study in Healthy Volunteers & Cystic Fibrosis PatientsCystic FibrosisOther: Hyperpolarized Xenon MRIPapworth Hospital NHS Foundation TrustUniversity of SheffieldNot recruiting18 Years70 YearsAll30Phase 3United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT02934139October 201616 December 2017MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9)A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of N91115 in Healthy SubjectsCystic FibrosisDrug: Cavosonstat;Other: PlaceboNivalis Therapeutics, Inc.Not recruiting18 Years55 YearsAll32Phase 1United States
192NCT02951182October 201627 August 2018A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic FibrosisCystic FibrosisDrug: Tezacaftor;Drug: Ivacaftor;Drug: VX-440;Drug: Matched PlacebosVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll74Phase 2United States;Australia;Austria;Belgium;Canada;Denmark;Germany;Italy;Spain;United Kingdom
193NCT02953314October 201615 October 2018A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic FibrosisA Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR MutationCystic FibrosisDrug: VX-661;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNot recruiting6 Years11 YearsAll70Phase 3United States;Canada
194EUCTR2015-003040-39-ES29/09/201617 October 2016Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infectionPseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 19.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.0 Level: PT Classification code 10070295 Term: Infective exacerbation of bronchiectasis System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Current Sponsor code: TBM100
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
180Phase 2France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
195EUCTR2016-002578-11-GB16/09/20163 April 2017A trial to determine the safest and most effective antibiotic strategy for infants diagnosed with CF.The cystic fibrosis (CF) anti-staphylococcal antibiotic prophylaxis trial (CF START); a randomised registry trial to assess the safety and efficacy of flucloxacillin as a longterm prophylaxis agent for infants with CF. - CF STARTCystic fibrosis
MedDRA version: 19.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Flucloxacillin 250mg/5ml Sugar-Free Powder for Oral Solution
Product Name: Flucloxacillin
Product Code: na
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Flucloxacillin
CAS Number: 5250-39-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 25-50-mg/ml
Alder Hey Children's NHS Foundation TrustAuthorisedFemale: yes
Male: yes
480Phase 4United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT02730208September 20164 November 2019A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR MutationA Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic FibrosisDrug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll41Phase 2Australia
197NCT02823964September 201611 June 2018EASY: Extended Access to Sollpura Over YearsAn Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisExocrine Pancreatic Insufficiency;Cystic FibrosisDrug: LiprotamaseAnthera PharmaceuticalsNot recruiting7 YearsN/AAll25Phase 4United States;Czechia;Hungary;Israel;Poland;Spain;Czech Republic
198NCT02875366September 201616 December 2017A Study of the Effects of Lumacaftor/Ivacaftor on Exercise Tolerance in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll70Phase 4Australia;United Kingdom
199EUCTR2016-001785-29-IE15/08/201629 August 2016Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.Combined Effect of CFTR Modifiers and Intensive Antibiotic TreatmentCystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Kalydeco
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 300-300
Trade Name: Ciprofloxacin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ciprofloxacin
CAS Number: 86393-32-0
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 1500-1500
Product Name: Flucloxicillin
Pharmaceutical Form: Powder for injection
INN or Proposed INN: FLUCLOXACILLIN SODIUM
CAS Number: 1847-24-1
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 4000-8000
Trade Name: Fortum
Pharmaceutical Form:
INN or Proposed INN: CEFTAZIDIME
CAS Number: 72558-82-8
Concentration unit: g gram(s)
Concentration type: range
Concentration number: 4-8
Product Name: Tobramycin
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: TOBRAMYCIN SULFATE
CAS Number: 79645-27-5
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 10-20
Trade Name: Meropenem
Pharmaceutical Form:
INN or Proposed INN: Meropenem
CAS Number: 96036-03-2
Other descriptive name: MEROPENEM
Concentration unit: g gram(s)
Concentration type: range
Concentration number: 3-8
Trade Name: Colistin
Pharmaceutical Form:
INN or Proposed INN: COLISTIMETHATE SODIUM
CAS Number: 8068-28-8
Concentration unit: Munit million units
Concentration type: range
Concentration number: 2-8
St. Vincent's University HospitalAuthorisedFemale: yes
Male: yes
Phase 4Ireland
200EUCTR2016-000166-35-NL08/08/201622 August 2016Inhaled nebulized tobramycin in non-CF bronchiectasisEffects of long term ToBrAmycin InhalaTion SoluTion (TIS) once daiLy on Exacerbation rate in patients with non-cystic fibrosis bronchiectasis. A double blind, randomized, placebo and TIS twice daily (open label) controlled trial. The BATTLE study.Patients with non-cystic fibrosis bronchiectasis
MedDRA version: 19.0 Level: PT Classification code 10070295 Term: Infective exacerbation of bronchiectasis System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Tobramycin Steri-Neb 300 mg/5 ml, inhalation solution
Pharmaceutical Form: Inhalation solution
Pharmaceutical form of the placebo: Inhalation solution
Route of administration of the placebo: Inhalation use
Noordwest ZiekenhuisgroepAuthorisedFemale: yes
Male: yes
Phase 2;Phase 3Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT02858843August 1, 201611 June 2018The Effect of Combination Lumacaftor and Ivacaftor on Markers of HyperglycemiaA Study of the Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia in Persons With Cystic FibrosisCystic Fibrosis;DiabetesDrug: lumacaftor-ivacaftorMassachusetts General HospitalNot recruiting18 Years65 YearsAll1N/A
202NCT02657473August 201616 December 2017Inhaled Nebulized Tobramycin in Non-cystic Fibrosis BronchiectasisLong-term Inhaled Nebulized Tobramycin in Patients With Non-cystic Fibrosis Bronchiectasis. A Randomized Placebo Controlled Trial. The BATTLE Study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy.Non-CF BronchiectasisDrug: tobramycin inhalation solution;Drug: Saline 0.9% inhalation solutionMedical Center AlkmaarRecruiting18 YearsN/AAll52Phase 2/Phase 3Netherlands
203NCT02866721August 201625 February 2019Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic FibrosisA Phase I, Single Center, Open Label, Single Dose, Dose Escalation Study Assessing the Safety and Tolerability of AllogeneiC MEsenchymAl Stem CEll Infusion in Adults With Cystic Fibrosis-CEASE CFCystic FibrosisBiological: Mesenchymal Stem CellsErica RoeschCase Western Reserve University;Cystic Fibrosis FoundationRecruiting18 YearsN/AAll15Phase 1United States
204NCT02918409August 201625 March 2019IV Colistin for Pulmonary Exacerbations: Improving Safety and EfficacyIV Colistin for Pulmonary Exacerbations: Improving Safety and EfficacyCystic FibrosisDrug: Colistin;Drug: TobramycinNational Jewish HealthRecruiting18 YearsN/AAll270Phase 4United States
205NCT02950883August 201616 September 2019Saline Hypertonic in Preschoolers + CTSaline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT)Cystic FibrosisDrug: Control Group 0.9% Isotonic Saline;Drug: Active Treatment Group 7% Hypertonic SalineUniversity of Washington, the Collaborative Health Studies Coordinating CenterCystic Fibrosis FoundationRecruiting3 Years5 YearsAll120Phase 2/Phase 3United States;Australia;Belgium;Canada;Denmark;France;Italy;Netherlands;Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT02750501July 20, 201620 August 2018Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) StudyAbsorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral FeedingCystic FibrosisDevice: RELiZORB (immobilized lipase) cartridge;Other: Impact Peptide 1.5Alcresta Therapeutics, Inc.Cystic Fibrosis Foundation TherapeuticsNot recruiting4 YearsN/AAll49N/AUnited States
207NCT03486236July 20, 201611 June 2018A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult SubjectsA Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult SubjectsCystic FibrosisDrug: VX-440;Drug: TEZ;Drug: IVA;Drug: Matched PlacebosVertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsAll16Phase 1United Kingdom
208NCT02718495July 19, 20161 April 2019Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic FibrosisA Phase I/II, Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic FibrosisCystic FibrosisDrug: PTI-428;Drug: PlaceboProteostasis Therapeutics, Inc.Not recruiting18 YearsN/AAll56Phase 1/Phase 2United States;Canada;Denmark;France;Germany;Czechia;United Kingdom
209NCT02555059July 15, 201628 January 2019Special Drug Use Investigation of Ciproxan Injection in PediatricsSpecial Drug Use Investigation of Ciproxan® Injection in PediatricsCystitis / Pyelonephritis / Cystic Fibrosis / AnthraxDrug: Cipro (Ciprofloxacin, BAYQ3939)BayerNot recruitingN/A14 YearsAll48Phase 4Japan
210NCT02992080July 12, 201625 February 2019Small Circulating RNA as Molecular Markers of Lung Disease in Cystic FibrosisDetermination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic FibrosisCystic FibrosisBiological: miRNAs isolation from blood samples of patients and controlUniversity Hospital, MontpellierRecruiting12 Months65 YearsAll80N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT02810691July 201620 August 2018The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic FibrosisThe Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic FibrosisCystic Fibrosis-related Diabetes;Cystic FibrosisDietary Supplement: Soluble fiber supplementation;Dietary Supplement: Placebo (for fiber supplementation)Institut de Recherches Cliniques de MontrealCanadian Cystic Fibrosis Foundation;Université de MontréalNot recruiting18 YearsN/AAll14N/ACanada
212NCT02807415June 1, 201611 March 2019ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With IvacaftorIntestinal Current Measurements (ICM) to Evaluate the Activation of Mutant CFTR in Subjects With Cystic Fibrosis Aged 12 Years and Older, Homozygous for the p.Phe508del-CFTR Mutation, Treated With Lumacaftor in Combination With IvacaftorCystic FibrosisDrug: Lumacaftor plus IvacaftorHannover Medical SchoolHeidelberg University;University of GiessenRecruiting6 YearsN/AAll100N/AGermany
213NCT02734810June 201611 June 2018SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic FibrosisA Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Cystic FibrosisDrug: Liprotamase Powder for Oral SolutionAnthera PharmaceuticalsNot recruitingN/AN/AAll15Phase 3United States
214NCT02781610June 201617 June 2019Standardized Treatment of Pulmonary Exacerbations IIStandardized Treatment of Pulmonary Exacerbations II (STOP2)Pulmonary Cystic FibrosisDrug: Standard of care IV antibiotic(s)Chris GossCystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating Center;Medical University of South Carolina;University of WashingtonRecruiting18 YearsN/AAll1300Phase 4United States;Canada
215NCT02823470June 201616 December 2017A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR MutationA Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del CFTR MutationCystic FibrosisDrug: LUM/IVA;Device: activated smart device;Device: de-activated smart deviceVertex Pharmaceuticals IncorporatedNot recruiting16 YearsN/AAll24Phase 4United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2016-000354-35-DK12/05/201613 March 2017High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urineHigh dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urinecystic fibrosis
MedDRA version: 19.0 Level: LLT Classification code 10068288 Term: Cystic fibrosis pulmonary exacerbation System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Mucolysin
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: ACETYLCYSTEINE SODIUM
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200-6oo
Trade Name: AAC Hexal
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLCYSTEINE SODIUM
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200-6oo
Aarhus University HospitalNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
217NCT02722122May 201610 October 2016Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®A Proof-of-Concept, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®Cystic FibrosisDrug: AIR DNase™ProtalixRecruiting12 YearsN/ABoth15Phase 2Israel
218NCT02797132May 201616 December 2017Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delA Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic FibrosisDrug: lumacaftor/ ivacaftorVertex Pharmaceuticals IncorporatedNot recruiting2 Years5 YearsAll60Phase 3United States;Canada
219NCT02850692April 18, 201626 August 2019Portal Hypertension and Systemic Endothelial FunctionPortal Hypertension and Systemic Endothelial Function: Investigation of Systemic Endothelial Dysfunction in Case of Portal Hypertension Associated With Cystic Fibrosis.Cystic Fibrosis;Portal HypertensionOther: measure of endothelial function;Biological: Blood sample;Other: Hepatic elastography;Diagnostic Test: Injected abdominal CTHopital FochRecruiting18 YearsN/AAll60N/AFrance
220NCT02724527April 201628 November 2016Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With IvacaftorA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 for Efficacy and Safety in Patients With CF Heterozygous for F508del-CFTR + Gating Mutation Being Treated With IvacaftorCystic FibrosisDrug: Cavosonstat;Drug: PlaceboNivalis Therapeutics, Inc.Not recruiting18 YearsN/ABoth19Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT02767297April 201631 October 2016Bioavailability and Pharmacokinetics Study of FDL169 in Healthy Subjects and Subjects With Cystic FibrosisA Three-Part Phase 1b Bioavailability and Pharmacokinetics Study of Two Formulations of FDL169 in Healthy Subjects and Subjects With Cystic FibrosisCystic FibrosisDrug: FDL169Flatley Discovery Lab LLCNot recruiting18 YearsN/ABoth46Phase 1/Phase 2United Kingdom
222EUCTR2016-000398-19-BE08/03/201630 April 2018Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients.Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. - pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenemCystic fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Trade Name: Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Meropenem Fresenius Kabi
Other descriptive name: MEROPENEM TRIHYDRATE
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Ceftazidim Fresenius Kabi
Other descriptive name: CEFTAZIDIME PENTAHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2000-
Trade Name: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Other descriptive name: PIPERACILLIN SODIUM
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Other descriptive name: TAZOBACTAM SODIUM
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 0.25-
Trade Name: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Other descriptive name: PIPERACILLIN SODIUM
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 4-
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Other descriptive name: TAZOBACTAM SODIUM
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 0.5-
Ghent UniversityNot RecruitingFemale: yes
Male: yes
45Phase 4Belgium
223NCT02354859March 20161 April 2019A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)Cystic FibrosisDrug: Gallium nitrate;Drug: Normal SalineUniversity of WashingtonCystic Fibrosis FoundationNot recruiting18 YearsN/AAll119Phase 2United States
224NCT02725567March 201628 January 2019A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have a CFTR Gating MutationA Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have a CFTR Gating MutationCystic FibrosisDrug: ivacaftorVertex Pharmaceuticals IncorporatedRecruitingN/A24 MonthsAll35Phase 3United States;Australia;Canada;Ireland;United Kingdom
225NCT02848560March 201618 June 2018Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRIValidation of MRI as a Sensitive Tool to Longitudinally Monitor CF Lung Disease Progression and Response to CFTR Modulator Therapy in Young Children With CFCystic FibrosisDrug: Hyperpolarized XenonChildren's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)Recruiting6 Years12 YearsAll38N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT02649751February 22, 201618 December 2018Evaluation of (R)-Roscovitine Safety and Effects in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase II, Dose Ranging, Multicenter, Double-blind, Placebo Controlled Study to Evaluate Safety and Effects of (R)-Roscovitine in Adults Subjects With Cystic Fibrosis, Carrying 2 Cystic Fibrosis Causing Mutations With at Least One F508del-CFTR Mutation and Chronically Infected With Pseudomonas Aeruginosa, a Study Involving 36 CF Patients (24 Treated, 12 Controls). ROSCO-CF.Cystic FibrosisDrug: Roscovitine;Drug: PlaceboUniversity Hospital, BrestManRos Therapeutics;Cyclacel Pharmaceuticals, Inc.Not recruiting18 YearsN/AAll49Phase 2France
227NCT02679729February 11, 201616 December 2017To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose AdministrationA Phase I, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Single-Ascending Inhaled Doses (Part A) and After Single Inhaled and Intravenous Doses (Part B) in Healthy SubjectsCystic FibrosisDrug: AZD5634 for inhalation;Drug: AZD5634 for infusion;Other: PlaceboAstraZenecaNot recruiting18 Years50 YearsAll63Phase 1United States
228NCT03512119February 11, 201611 June 2018Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorObservational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorCystic Fibrosis Homozygous for Phe 508 Del CFTR;Glucose Intolerance or Newly Diagnosis DiabetesDrug: Lumacaftor-Ivacaftor treatmentUniversity Hospital, Strasbourg, FranceRecruiting12 YearsN/AAll100N/AFrance
229EUCTR2015-002677-38-GB04/02/201628 February 2019An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CFCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011763 Term: Cystic fibrosis lung System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: CTX-4430
Product Code: CTX-4430
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: acebilustat
CAS Number: 943764-99-6
Current Sponsor code: CTX-4430
Other descriptive name: CRC3357, ZK-355322, Leukoton
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: CTX-4430
Product Code: CTX-4430
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: acebilustat
CAS Number: 943764-99-6
Current Sponsor code: CTX-4430
Other descriptive name: CRC3357, ZK-355322, Leukoton
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Celtaxsys Inc.Not Recruiting Female: yes
Male: yes
195Phase 2France;United States;Canada;Belgium;Germany;Italy;United Kingdom
230NCT02625246February 4, 20169 September 2019Safety and Potential Efficacy of Human Mesenchymal Stem Cells in Non-Cystic Fibrosis BronchiectasisA Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell (hMSC) Infusion in Patients With Non-Cystic Fibrosis BronchiectasisBronchiectasisBiological: hMSCsMarilyn GlassbergNot recruiting30 Years87 YearsAll6Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2015-003291-77-GB02/02/20162 May 2016A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutationCystic fibrosis with the G551D mutation
MedDRA version: 18.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
Pharmaceutical Form: Tablet
INN or Proposed INN: Not Applicable
CAS Number: 1654725-02-6
Current Sponsor code: GLPG1837
Other descriptive name: GLPG1837
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Product Name: GLPG1837
Product Code: GLPG1837
Pharmaceutical Form: Tablet
INN or Proposed INN: Not Applicable
CAS Number: 1654725-02-6
Current Sponsor code: GLPG1837
Other descriptive name: GLPG1837
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Product Name: GLPG1837
Product Code: GLPG1837
Pharmaceutical Form: Tablet
INN or Proposed INN: Not Applicable
CAS Number: 1654725-02-6
Current Sponsor code: GLPG1837
Other descriptive name: GLPG1837
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 62.5-
Galapagos NVAuthorisedFemale: yes
Male: yes
32Phase 2aCzech Republic;Ireland;Australia;Germany;United Kingdom
232NCT02508207February 201616 December 2017A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Exploratory Study to Evaluate Effects of VX-661 in Combination With Ivacaftor on Lung and Extrapulmonary Systems in Subjects Aged 18 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: VX-661/ivacaftor;Drug: ivacaftor;Drug: VX-661/ ivacaftor matching placebo;Drug: ivacaftor matching placeboVertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll34Phase 2United States
233NCT02684552February 201612 September 2016Non Invasive Ventilation During Physical Training in Cystic FibrosisPhysiotherapist in Charge of the StudyCystic FibrosisDevice: Non invasive ventilation;Device: OxygenKarolinska University HospitalNot recruiting18 Years90 YearsBoth8N/ASweden
234NCT02694393February 201624 September 2018Inhaled Sodium Nitrite as an Antimicrobial for Cystic FibrosisPhase I/II Study of Inhaled Sodium Nitrite as an Antimicrobial for Pseudomonas Infection in Cystic FibrosisCystic FibrosisDrug: sodium nitriteSchmidhofer, Mark, MDMast Therapeutics, Inc.;Cystic Fibrosis Foundation TherapeuticsRecruiting18 YearsN/AAll35Phase 1/Phase 2United States
235NCT02709109February 201615 October 2018A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With OrkambiCystic FibrosisDrug: VX-371;Drug: Saline;Drug: Placebo;Drug: OrkambiVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll142Phase 2United States;France;Ireland;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT02840136February 201625 June 2018LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis PatientsOptimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and ValidationCystic FibrosisDrug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: CeftazidimeUniversity GhentKing Baudouin Foundation;Belgische Vereniging voor Strijd tegen MucoviscidoseNot recruiting12 YearsN/AAll40N/ABelgium
237EUCTR2015-001644-11-GB22/01/20167 January 2019Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX 809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
INN or Proposed INN: Lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX 809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
256Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
238NCT03475381January 22, 201611 June 2018Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)Cystic FibrosisDrug: Ivacaftor+lumacaftorAssistance Publique - Hôpitaux de ParisEffi-stat;Société Française de la MucoviscidoseNot recruiting12 YearsN/AAll685N/AFrance
239EUCTR2015-003292-30-BE18/01/20168 August 2016A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the S1251N mutationA phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation.Cystic fibrosis with the S1251N mutation
MedDRA version: 18.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
Pharmaceutical Form: Tablet
INN or Proposed INN: Not Applicable
CAS Number: 1654725-02-6
Current Sponsor code: GLPG1837
Other descriptive name: GLPG1837
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 62.5-
Product Name: GLPG1837
Product Code: GLPG1837
Pharmaceutical Form: Tablet
INN or Proposed INN: Not Applicable
CAS Number: 1654725-02-6
Current Sponsor code: GLPG1837
Other descriptive name: GLPG1837
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Galapagos NVNot RecruitingFemale: yes
Male: yes
6Phase 2Belgium;Netherlands
240NCT02646995January 201618 June 2018Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) PatientsCystic FibrosisDietary Supplement: modified lipid formulation;Dietary Supplement: Fish oilNestléNot recruiting5 Years18 YearsAll16N/ASwitzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241NCT02661438January 201618 April 2016Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using PlaceboMulticenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching PlaceboBronchiectasis;Pulmonary Disease, Chronic ObstructiveDrug: Placebo to Ciprofloxacin DPI (BAYQ3939)BayerNovartisNot recruiting40 YearsN/ABoth46N/AUnited States
242EUCTR2016-001840-20-Outside-EU/EEA23 May 2016Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis PatientsA Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules.cystic fibrosis
MedDRA version: 19.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Pharmaceutical Form: Inhalation powder, hard capsule
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Novartis Pharmaceuticals CorporationNot AvailableFemale: yes
Male: yes
45Phase 4United States
243EUCTR2016-004318-82-Outside-EU/EEA22 May 2017A study comparing Tobramycin Inhalation Powder (TIP) administered once daily continuously versus TIP administered BID in 28 day on / 28 day off cycles for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosisTobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off CyclesCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0 Level: LLT Classification code 10021860 Term: Infection Pseudomonas aeruginosa System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: TOBI Podhaler
Pharmaceutical Form: Capsule
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 112-
Novartis Pharmaceuticals CorporationNot AvailableFemale: yes
Male: yes
200Phase 4United States
244EUCTR2016-004479-35-IE28 February 2019A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Other descriptive name: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Vertex Pharmaceuticals IncorporatedNot Recruiting Female: yes
Male: yes
65Phase 3France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
245EUCTR2016-004786-80-DE26 November 2018Tolerability and Efficacy of Anakinra in patients with cystic fibrosis.A phase IIa, randomized, placebo-controlled, double-blind, cross-over study to evaluate safety and efficacy of subcutanous administration of anakinra in patients with cystic fibrosis. - ANAKINCystic fibrosis
MedDRA version: 20.0 Level: LLT Classification code 10028141 Term: Mucoviscidosis System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kineret
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Ruprecht-Karls-University Heidelberg, Medical FacultyNot AvailableFemale: yes
Male: yes
52Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246NCT02589444December 201516 December 2017Vitamin D and Microbiota in Cystic FibrosisPilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic FibrosisVitamin D Deficiency;Cystic FibrosisDietary Supplement: High-Dose Vitamin D3;Other: Stool Sample;Other: Sputum Sample;Other: Sham Comparator;Procedure: Blood drawEmory UniversityNot recruiting18 YearsN/AAll41N/AUnited States
247NCT02605590December 201530 May 2016Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult VolunteersA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AIR-DNase When Administered by Inhalation to Healthy Adult SubjectsCystic Fibrosis (CF)Drug: AIR DNase;Drug: PlaceboProtalixNot recruiting18 Years55 YearsMale18Phase 1Israel
248NCT02626182December 201529 July 2019Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe CFEvaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: sildenafil;Drug: placeboNational Jewish HealthNot recruiting18 YearsN/AAll14Phase 1/Phase 2United States
249NCT02680418December 201511 April 2016Pharmacokinetics of FDL169 in Healthy Female SubjectsA Phase I Dose Escalation Study to Assess the Pharmacokinetics (PK) of FDL169 in Healthy Female VolunteersCystic FibrosisDrug: FDL169Flatley Discovery Lab LLCNot recruiting18 Years55 YearsFemale8Phase 1United Kingdom
250EUCTR2015-003662-87-DK13/11/20152 October 2017Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of lifePseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or ColistinChronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.
MedDRA version: 18.1 Level: LLT Classification code 10051190 Term: Pneumonia Pseudomonas aeruginosa System Organ Class: 100000004862
MedDRA version: 18.1 Level: LLT Classification code 10050700 Term: Chronic respiratory disease NOS System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: colistimethate sodium (promixin)
Pharmaceutical Form: Inhalation vapour, powder
INN or Proposed INN: COLISTIMETHATE SODIUM
CAS Number: 8068-28-8
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000000-
Trade Name: Piperacillin with Tazobactam (tazocin)
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: PIPERACILLIN
Other descriptive name: PIPERACILLIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4000-
INN or Proposed INN: TAZOBACTAM
Other descriptive name: TAZOBACTAM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Aarhus University Hospital, Department of Respiratory MedicineNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT02589236November 201516 December 2017Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 to Evaluate Efficacy and Safety in Patients With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Treated With Lumacaftor/IvacaftorCystic FibrosisDrug: Cavosonstat;Drug: PlaceboNivalis Therapeutics, Inc.Medidata SolutionsNot recruiting18 YearsN/AAll138Phase 2United States
252NCT02598999November 201513 May 2019Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis PatientsRandomized, Double Blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics After Single Ascending Doses or Multiple Ascending Doses of OSCN-, bLF or ALX-009 in Healthy Male and CF and Non-CF Bronchiectasis PatientsCystic Fibrosis;BronchiectasisDrug: ALX-009;Drug: OSCN-;Drug: bLF;Drug: PlaceboAlaxia SASRecruiting18 Years50 YearsAll103Phase 1France
253NCT02443688October 30, 201526 August 2019EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) PatientsA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic FibrosisCystic FibrosisDrug: CTX-4430;Drug: PlaceboCeltaxsys, Inc.Not recruiting18 Years30 YearsAll200Phase 2United States;Belgium;Canada;France;Germany;Italy;United Kingdom
254NCT01132482October 201516 December 2017Effects of Sildenafil on CFTR-dependent Ion Transport ActivityPhase II Study of the Effects of Sildenafil on CFTR-dependent Ion Transport ActivityCystic FibrosisDrug: Sildenafil;Drug: PlaceboNational Jewish HealthNot recruiting18 YearsN/AAll23Phase 2United States
255NCT02518672October 201516 December 2017Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis.Cystic FibrosisDietary Supplement: MAG-DHA;Dietary Supplement: PlaceboSCF PharmaCentre de recherche du Centre hospitalier universitaire de Sherbrooke;Solutex (Spain)Not recruiting18 YearsN/AAll11Phase 2Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT02465450September 29, 201511 June 2018Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic FibrosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic FibrosisCystic FibrosisDrug: JBT-101 (lenabasum);Other: PlaceboCorbus Pharmaceuticals Inc.Not recruiting18 Years65 YearsAll85Phase 2United States;Belgium;France;Germany;Italy;Poland;United Kingdom
257EUCTR2014-004787-37-AT21/09/20155 September 2016A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)Cystic Fibrosis
MedDRA version: 19.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not yet assigned
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661 VRT-0893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Australia;Austria;Israel;Germany
258EUCTR2015-002911-13-FR15/09/20157 January 2019A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis.A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis, homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa, a study involving 36 CF patients (24 treated, 12 controls). - ROSCO-CFCystic Fibrosis treated by 'roscovitine' in subjects homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.
MedDRA version: 18.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SELICICLIB
Product Code: CYC202
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
CHRU de BrestNot RecruitingFemale: yes
Male: yes
36Phase 2France
259EUCTR2014-004827-29-IT01/09/201521 September 2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR MutationCystic Fibrosis
MedDRA version: 18.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: Not yet assigned
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
260NCT02605538September 1, 201527 August 2018Hepatitis B in Cystic Fibrosis and Latent Tuberculosis RespectivelyHepatitis B in Cystic Fibrosis and Latent Tuberculosis RespectivelyCystic Fibrosis;Hepatitis A;Hepatitis B;TuberculosisBiological: Vaccination with vaccine against hepatitis A and BKarolinska University HospitalKarolinska InstitutetRecruiting1 YearN/AAll250N/ASweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261NCT02421120September 201516 December 2017Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis PatientsA Prospective, Multicenter, Open-Label Study to Assess Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients Admitted With Acute Pulmonary ExacerbationCystic Fibrosis;Cystic Fibrosis Pulmonary Exacerbation;Pseudomonas Aeruginosa InfectionDrug: Ceftolozane/TazobactamJoseph KutiCubist Pharmaceuticals LLC;Indiana University Health;University of North Carolina;St. Christopher's Hospital for ChildrenNot recruiting18 YearsN/AAll21Phase 4United States
262NCT02504827September 201511 June 2018Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic FibrosisSteady-state Pharmacokinetics of Ceftazidime/Avibactam in CFCystic FibrosisDrug: Ceftazidime/avibactamUniversity of Southern CaliforniaNot recruiting18 YearsN/AAll12Phase 4United States
263NCT02564354September 201521 November 2016Exploratory Study to Evaluate QR-010 in Subjects With Cystic Fibrosis ?F508 CFTR MutationOpen-Label, Exploratory Study to Evaluate the Effects of QR-010 on Nasal Potential Difference in Subjects With CF With the ?F508 CFTR MutationCystic FibrosisDrug: QR-010ProQR TherapeuticsEuropean CommissionNot recruiting18 YearsN/ABoth18Phase 1United States;Belgium;France
264NCT03497117August 25, 201522 October 201919F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation19F Magnetic Resonance Imaging of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary ExacerbationCystic FibrosisDevice: Lung Clearance Index;Drug: MRI with PFPUniversity of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years99 YearsAll16Early Phase 1United States
265NCT02496780August 201511 November 2019The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis PatientsThe Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis PatientsCystic FibrosisDrug: novolog insulin;Drug: levemir insulin;Drug: placeboUniversity of MinnesotaChildren's Hospitals and Clinics of MinnesotaRecruiting10 Years25 YearsAll80Phase 2/Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT02531984August 20157 September 2015The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis BronchiectasisOpen Trial With Randomized Withdrawal of Treatment, to Evaluate the Efficacy of Azithromycin in the Treatment of Children With Non Cystic Fibrosis Bronchiectasis ( AZI-STOP Study )Non Cystic Fibrosis Bronchiectasis in ChildrenDrug: AzithromycinAssistance Publique Hopitaux De MarseilleNot recruiting3 Years17 YearsBoth100Phase 3
267NCT02535130August 201529 August 2016Evaluation of Nebulization and Positive Expiratory Pressure CombinationCystic Fibrosis;Healthy SubjectsDevice: Positive expiratory pressure;Drug: amikacine nebulizationCliniques universitaires Saint-Luc- Université Catholique de LouvainRecruiting16 Years55 YearsBoth15N/ABelgium
268NCT02544451August 20159 October 2018Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With IvacaftorA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: Ivacaftor;Drug: LumacaftorVertex Pharmaceuticals IncorporatedNot recruiting6 YearsN/AAll240Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom
269NCT02565914August 201522 October 2019A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis Who Have an F508del-CFTR MutationA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: VX-661/ivacaftor;Drug: ivacaftorVertex Pharmaceuticals IncorporatedRecruiting12 YearsN/AAll1116Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
270NCT02740868August 201515 April 2019Xenon-129 Lung Magnetic Resonance Imaging: Study of Healthy Volunteers and Participants With Pulmonary DiseaseDevelopment of Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging: Comparative Pilot Study of Healthy Volunteers and Participants With Pulmonary DiseaseCystic Fibrosis;AsthmaDrug: Xenon-129;Device: Magnetic Resonance Imaging;Device: Lung Clearance IndexThe Hospital for Sick ChildrenRecruiting8 YearsN/AAll30Phase 2Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT02310789July 31, 201511 June 2018(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?(Study: Vertex IIS) A Study To Access the Effects of Ivacaftor on Wild Type CFTR-Open Probability (PO) In The Sweat Gland Secretory CoilCystic FibrosisDrug: Ivacaftor;Drug: ß-Adrenergic cocktail;Drug: Pilocarpine Nitrate 5%;Device: Macroduct sweat stimulatorRichard Barry MossNot recruiting18 YearsN/AAll8N/AUnited States
272NCT02456103July 31, 20154 February 2019Extension Study of Ataluren for Nonsense Mutation Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Cystic FibrosisCystic FibrosisDrug: AtalurenPTC TherapeuticsNot recruiting6 YearsN/AAll246Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
273EUCTR2015-001317-28-NL30/07/201522 May 2017A B2-agonist as a CFTR activator in CF - Part 2A B2-agonist as a CFTR activator in CF - Part 2 - ABBA 2Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Salbutamol
Pharmaceutical Form: Tablet
UMC UtrechtNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
274NCT02444234July 201511 June 2018Pharmacokinetics of Tedizolid Phosphate in Cystic FibrosisSteady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic FibrosisCystic FibrosisDrug: Tedizolid PO/IV;Drug: Tedizolid IV/POUniversity of Southern CaliforniaMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AAll11Phase 4United States
275NCT02514473July 201516 December 2017A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR MutationA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: VX-809;Drug: Placebo;Drug: VX-770Vertex Pharmaceuticals IncorporatedNot recruiting6 Years11 YearsAll206Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276EUCTR2015-000543-16-GB19/06/201513 June 2016A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
277NCT02239458June 201528 April 2015DPP-IV Inhibition Prior to Development of Diabetes in Patients With Cystic FibrosisCystic FibrosisDrug: SaxagliptinRam WeissNot recruiting18 Years65 YearsBoth60N/AIsrael
278NCT02279498June 201520 August 2018SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic FibrosisA Phase 3, Randomized, Open-Label, Assessor-Blind, Noninferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Cystic FibrosisDrug: Liprotamase;Drug: porcine (pig) PERTAnthera PharmaceuticalsNot recruiting7 YearsN/AAll128Phase 3United States;Canada;Czechia;Hungary;Israel;Poland;Spain;Czech Republic
279NCT02532764June 201516 December 2017Dose Escalation Study of QR-010 in Homozygous ?F508 Cystic Fibrosis PatientsPhase 1b, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of QR-010 in Subjects With Homozygous ?F508 Cystic FibrosisCystic FibrosisDrug: QR-010;Drug: PlaceboProQR TherapeuticsEuropean CommissionNot recruiting18 Years60 YearsAll64Phase 1/Phase 2United States;Belgium;Canada;Czechia;Denmark;France;Germany;Italy;Spain;United Kingdom;Czech Republic;Netherlands
280EUCTR2014-004838-25-IT20/05/201519 February 2018A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor ResponsiveCystic Fibrosis
MedDRA version: 17.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not yet assigned
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Other descriptive name: VRT-893661 VRT-0893661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT02449031May 5, 201514 January 2019Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial DrugsA Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® Podhaler™ (Tobramycin Inhalation Powder) or Other FDA Approved Inhaled Antipseudomonal Antibacterial DrugsPseudomonas Aeruginosa in Cystic FibrosisDrug: TOBI Podhaler;Drug: TOBI;Drug: Bethkis;Drug: CaystonMylan Inc.Cystic Fibrosis FoundationNot recruiting6 YearsN/AAll260N/AUnited States
282NCT02468908May 201516 December 2017Inhaled Molgramostim (rhGM-CSF) in Healthy Adult SubjectsA Randomized, Double-Blind, Placebo-Controlled, Single-Centre, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Molgramostim When Administered by Inhalation to Healthy Adult SubjectsPulmonary Alveolar Proteinosis;Bronchiectasis;Cystic Fibrosis;Acute Respiratory Distress SyndromeDrug: Molgramostim;Drug: PlaceboSavara Inc.CelerionNot recruiting18 Years55 YearsAll42Phase 1United Kingdom
283NCT02343445April 201522 August 2016Clearing Lungs With ENAC Inhibition in Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of P-1037 Solution for Inhalation in Patients With Cystic Fibrosis (CF)Cystic FibrosisDrug: P-1037;Drug: Hypertonic Saline;Drug: SalineVertex Pharmaceuticals IncorporatedParion SciencesNot recruiting12 Years80 YearsBoth142Phase 2United States
284NCT02445053April 201526 August 2019Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)Cystic FibrosisDrug: ivacaftorVertex Pharmaceuticals IncorporatedNot recruiting6 YearsN/AAll90N/AItaly;Netherlands;United Kingdom
285NCT02690064April 201522 October 2019Mechanisms for Vascular Dysfunction and Exercise Tolerance in CFMechanisms for Vascular Dysfunction and Exercise Tolerance in CFCystic FibrosisDietary Supplement: Acute Antioxidant;Dietary Supplement: Chronic Antioxidant;Other: PlaceboAugusta UniversityRecruiting7 YearsN/AAll80N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT02325362March 17, 201511 June 2018Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del MutationSingle Center, Double-blind, Randomized, Placebo-controlled, Two-period/Two-treatment Crossover, Proof-of-mechanism Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Adult Patients With Cystic Fibrosis Homozygous for the F508del MutationCystic FibrosisDrug: Miglustat ; placebo;Drug: Placebo ; MiglustatAssistance Publique - Hôpitaux de ParisActelion;CRCM (Centres de Ressources et de Compétences de la Mucoviscidose)Not recruiting18 YearsN/AAll16Phase 2/Phase 3France
287NCT02378467March 1, 201511 February 2019Saline Hypertonic in PreschoolersSaline Hypertonic in PreschoolersCystic FibrosisDrug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS)University of Washington, the Collaborative Health Studies Coordinating CenterCystic Fibrosis FoundationNot recruiting3 Years5 YearsAll150N/AUnited States;Canada
288NCT02390219March 201516 December 2017Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung DiseaseA Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR MutationCystic Fibrosis;Advanced Lung DiseaseDrug: Lumacaftor;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll46Phase 3United States
289NCT02392234March 201526 February 2018A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual FunctionCystic FibrosisDrug: VX-661/ivacaftor;Drug: ivacaftor;Drug: VX-661/ ivacaftor placebo;Drug: ivacaftor placeboVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll246Phase 3United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;United Kingdom;Switzerland
290NCT02275936February 201514 November 2016Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR MutationA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Study of N91115 to Evaluate Safety and Pharmacokinetics in Patients With Cystic Fibrosis Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: N91115Nivalis Therapeutics, Inc.Not recruiting18 Years80 YearsBoth51Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291NCT02453789February 201511 June 2018A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. InfectionA Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp.Cystic Fibrosis;Burkholderia InfectionDrug: Alginate oligosaccharide;Drug: PlaceboAlgiPharma ASNot recruiting18 YearsN/AAll15Phase 2Germany
292NCT02489955February 20153 August 2015Antibiotic Nephrotoxicity in Adult Patients With Cystic FibrosisProspective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF)Cystic FibrosisDrug: Amikacin;Drug: Tobramycin;Drug: ColomycinThe Leeds Teaching Hospitals NHS TrustRecruiting18 YearsN/ABothN/AUnited Kingdom
293ChiCTR-IPC-150059152015-01-3118 April 2017A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of BronchiectasisA Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasisnon-cystic fibrosis bronchiectasisExperimental group:Routine treatment combining with the therapy of bronchoalveolar lavage and local drug injection (Amikacin);Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of MedicineRecruiting1880BothExperimental group:50;New Treatment Measure Clinical Study
294NCT02248922January 27, 201516 December 2017Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.AeruginosaAn 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients = 6 Years of Age, Chronically Infected With Pseudomonas AeruginosaChronic Lung Infection With Pseudomonas Aeruginosa in Cystic FibrosisDrug: TIS or TIPNovartis PharmaceuticalsNot recruiting6 YearsN/AAll17Phase 4Germany
295EUCTR2014-004519-35-HU09/01/20154 August 2015A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisPancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NOT APPLICABLE
CAS Number: 8049-47-6
Current Sponsor code: CREON IR
Other descriptive name: PANCREATIN (Pancreas Powder)
Concentration unit: U unit(s)
Concentration type: range
Concentration number: 4000-30000
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not assigned
CAS Number: 8049-47-6
Other descriptive name: PANCREATIN (Pancreas Powder)
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 25000-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Abbott Laboratories GmbHNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296NCT02347657January 201526 February 2018A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With IvacaftorA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic FibrosisDrug: VX-661/ ivacaftor;Drug: ivacaftor;Drug: VX-661/ ivacaftor placebo;Drug: ivacaftor placeboVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll509Phase 3United States;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
297NCT02359357January 201518 April 2016FTIH - Single and Repeat Oral Doses of FDL169 in Healthy VolunteersA Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy VolunteersCystic FibrosisDrug: FDL169;Drug: PlaceboFlatley Discovery Lab LLCNot recruiting18 Years45 YearsMale130Phase 1United Kingdom
298NCT02507843January 20153 August 2015Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis BronchiectasisVitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled TrialBronchiectasisDrug: Cholecalciferol;Drug: PlaceboShanghai Pulmonary Hospital, Shanghai, ChinaRecruiting18 YearsN/ABoth200Phase 4China
299NCT02526004January 201531 August 2015Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results StratifiedCystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results StratifiedCystic FibrosisDrug: Ceftazidime;Drug: TobramycinUniversity College CorkQueen's University, Belfast;Paris Descartes University;University of Dundee;University of Washington;University Hospital Heidelberg;Teagasc;Clininfo;GABO:mi;Papworth Hospital;Katholieke Universiteit Leuven;Assistance Publique - Hôpitaux de Paris;European UnionRecruiting16 Years80 YearsBoth252N/AIreland
300NCT04122547January 201522 October 2019Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis BronchiectasisEfficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled TrialExacerbation Copd;Bronchiectasis;Lung Function DecreasedDrug: Roflumilast;Drug: PlaceboPrince of Songkla UniversityNot recruiting18 Years80 YearsAll40Phase 3Thailand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301EUCTR2015-000395-97-Outside-EU/EEA16 February 2015A Clinical Trial to Evaluate the Effects of the drug Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and infection with the bacteria Pseudomonas aeruginosa (AIR-CF4)A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (AIR-CF4)Cystic Fibrosis with Mild Lung Disease and P. aeruginosa (AIR-CF4);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Cayston
INN or Proposed INN: AZTREONAM
CAS Number: 78110-38-0
Current Sponsor code: AZLI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Powder and solvent for nebuliser solution
Route of administration of the placebo: Inhalation use
Gilead Sciences, Inc.Gilead Sciences Pty Ltd;Gilead Sciences Canada, Inc.Not AvailableFemale: yes
Male: yes
157United States;Australia;Canada
302EUCTR2015-000396-26-Outside-EU/EEA16 February 2015Program to Give the Drug Aztreonam Lysine for Inhalation to Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease ProgressionExpanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease ProgressionAdult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Cayston
INN or Proposed INN: AZTREONAM
CAS Number: 78110-38-0
Current Sponsor code: AZLI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Gilead Sciences, Inc.Not AvailableFemale: yes
Male: yes
603United States
303EUCTR2015-000397-36-Outside-EU/EEA16 February 2015Program to Give the Drug Aztreonamn Lysine for Inhalation to Canadian Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease ProgressionExpanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease ProgressionAdult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 17.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
INN or Proposed INN: AZTREONAM
CAS Number: 78110-38-0
Current Sponsor code: AZLI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Gilead Sciences, Inc.Not AvailableFemale: yes
Male: yes
45Canada
304EUCTR2015-001219-11-Outside-EU/EEA7 April 2015A study of the efficacy and tolerability of pancrelipase microtablet (MT) capsules for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiencyA randomized double-blind (withdrawal) phase 3 study to evaluate the efficacy and tolerability of pancrelipase MT capsules compared with placebo in the treatment of subjects with cystic fibrosis-dependent exocrine pancreatic insufficiencyCystic fibrosis
MedDRA version: 17.1 Level: LLT Classification code 10011765 Term: Cystic fibrosis pancreas System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: PANCREASE MT
Product Name: PANCREASE MT
Pharmaceutical Form: Capsule
INN or Proposed INN: pancrelipase
Other descriptive name: PANCRELIPASE AMYLASE
Concentration unit: Other
Concentration type: up to
Concentration number: 10000-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.Not AvailableFemale: yes
Male: yes
40Phase 3United States;Canada
305EUCTR2015-001225-16-Outside-EU/EEA10 July 2015A Study to Evaluate the Pharmacokinetics and Safety of Doripenem in Children and Adolescents with Cystic FibrosisAn Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Doripenem in Pediatric Subjects 6 to 17 Years of age, Inclusive, With Cystic FibrosisCystic fibrosis
MedDRA version: 18.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: DORIBAX
Product Name: DORIBAX
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: DORIPENEM HYDRATE
CAS Number: 364622-82-2
Other descriptive name: DORIPENEM HYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Johnson & Johnson Pharmaceutical Research & Development L.L.CNot AvailableFemale: yes
Male: yes
22United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2015-001267-39-FR2 October 2017A study to assess the efficacy and safety of ivacaftor in children aged 3 to 5 with Cystic Fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating MutationCystic Fibrosis
MedDRA version: 18.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Granules
Route of administration of the placebo: Oral use
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Granules
Route of administration of the placebo: Oral use
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Kalydeco
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Vertex Pharmaceuticals IncorporatedNot AvailableFemale: yes
Male: yes
50Phase 3France;Canada;Australia;United Kingdom
307EUCTR2015-001644-11-SE18 June 2018Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX 809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
INN or Proposed INN: Lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX 809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Vertex Pharmaceuticals IncorporatedNot AvailableFemale: yes
Male: yes
256Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
308EUCTR2015-001997-16-GB28 February 2019A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have a CFTR Gating MutationCystic Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Vertex Pharmaceuticals IncorporatedNot Available Female: yes
Male: yes
35Phase 3United States;Canada;Ireland;Germany;United Kingdom
309EUCTR2015-004841-13-FR28 February 2019A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With OrkambiCystic Fibrosis
MedDRA version: 19.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Not yet assigned
Current Sponsor code: VX-371
Other descriptive name: VX-371
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: up to
Concentration number: 30-
Product Code: VX-371 in saline
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Not yet assigned
Current Sponsor code: VX-371
Other descriptive name: VX-371
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: up to
Concentration number: 30-
Pharmaceutical form of the placebo: Inhalation solution
Route of administration of the placebo: Inhalation use
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Other descriptive name: Ivacaftor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
INN or Proposed INN: Lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Other descriptive name: LUMACAFTOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Product Name: Hypertonic saline
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: 4.2% NaCl/inhalation solution
Vertex Pharmaceuticals Inc.Not Recruiting Female: yes
Male: yes
150Phase 2United States;France;Czech Republic;Ireland;United Kingdom
310EUCTR2014-002125-35-DE18/12/201420 August 2018A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp.A randomized double-blind, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) for 28 days in subjects with Cystic Fibrosis using aztreonam due to chronic colonization with Burkholderia spp. - A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp.Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: OligoG CF-5/20
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Oligomer of Sodium Alginate
Current Sponsor code: OligoG
Other descriptive name: OLIGOG CF-5/20
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 35-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Algipharma ASNot RecruitingFemale: yes
Male: yes
12Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT02262871December 201411 June 2018HFN Versus NIV in Cystic Fibrosis. The HIFEN StudyRandomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN StudyCystic FibrosisDevice: High flow nasal oxygen cannula;Device: Noninvasive ventilationSt. Michael's Hospital, TorontoNot recruiting18 YearsN/AAll15N/ACanada
312NCT02273661November 19, 20146 May 2019Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)Allergic Bronchopulmonary AspergillosisDrug: Liposomal amphotericin B (Ambisome®);Drug: placeboPoitiers University HospitalNot recruiting18 YearsN/AAll174Phase 2France
313EUCTR2014-001204-21-DE17/11/20142 October 2017An open-label clinical trial that evaluates the lung clearance index in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosaAn 8 week open-label interventional multicenter study to evaluate the lung clearance index as endpoint for clinical trials in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosaChronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 18.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0 Level: LLT Classification code 10021860 Term: Infection Pseudomonas aeruginosa System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Current Sponsor code: TBM100
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28-
Pharmaceutical Form: Nebulisation solution
INN or Proposed INN: Tobramycin
CAS Number: 3232986-56-4
Current Sponsor code: TBM100
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Novartis Pharma GmbHNot RecruitingFemale: yes
Male: yes
Phase 4Germany
314NCT03312140November 6, 201416 December 2017Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic FibrosisExamination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic FibrosisCystic Fibrosis Liver DiseaseDrug: Choline ChlorideUniversity Hospital TuebingenNot recruiting18 YearsN/AMale10N/A
315EUCTR2013-005357-79-CZ15/10/20148 August 2016Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsCystic Fibrosis
MedDRA version: 19.0 Level: LLT Classification code 10011764 Term: Cystic fibrosis NOS System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Pharmaxis LimitedNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316NCT02134353October 201411 June 2018A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsCystic FibrosisDrug: Inhaled mannitol;Drug: Placebo Comparator: Arm B - ControlPharmaxisNot recruiting18 Years99 YearsAll423Phase 3United States;Argentina;Australia;Belgium;Canada;Czechia;Hungary;Israel;Italy;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;France
317NCT02157922October 201411 June 2018A Phase IIb Study of OligoG in Subjects With Cystic FibrosisA Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic FibrosisCystic FibrosisDrug: alginate oligosaccharideAlgiPharma ASEurostars;Smerud Medical Research International ASNot recruiting18 YearsN/AAll65Phase 2Denmark;Germany;Norway;Sweden;United Kingdom
318NCT02194881October 201416 December 2017Ivacaftor in French Patients With Cystic Fibrosis and a G551D MutationIvacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting.Cystic FibrosisDrug: CF patients with a G551D mutation and treated with IvacaftorAssistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseNot recruiting6 YearsN/AAll57N/AFrance
319NCT02227888October 201414 November 2016PK Study of N91115 in Cystic Fibrosis PatientsA Phase 1, Open-Label Study Evaluating the Pharmacokinetics of N91115 in Cystic Fibrosis PatientsCystic FibrosisDrug: N91115Nivalis Therapeutics, Inc.Not recruiting18 YearsN/ABoth6Phase 1United States
320NCT02372383October 20148 August 2016Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic FibrosisPharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus ControlsCystic FibrosisDrug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: PancrelipaseUniversity of Colorado, DenverCystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences InstituteNot recruiting16 Years45 YearsBoth32N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2014-000844-13-DK25/09/20148 August 2016A phase IIb study of OligoG in subjects with cystic fibrosisA double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosisCystic Fibrosis
MedDRA version: 17.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Oligomer of Sodium Alginate
Current Sponsor code: OligoG
Other descriptive name: OLIGOG CF-5/20
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 35-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Algipharma ASNot RecruitingFemale: yes
Male: yes
76Phase 2Denmark;Germany;Sweden
322EUCTR2013-004595-35-GB11/09/201411 June 2018Safety and tolerability of BAY63-2521 in Cystic Fibrosis patientsMulti-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patientsCystic Fibrosis
MedDRA version: 19.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Product Name: Adempas 0.125 mg
Product Code: BAY63-2521
Pharmaceutical Form: Film-coated tablet
Bayer AGNot RecruitingFemale: yes
Male: yes
63Phase 2France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom
323NCT02212587September 201420 June 2016Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia ComplexPilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia ComplexCystic Fibrosis;Burkholderia Cepacia InfectionDrug: TOBISt. Michael's Hospital, TorontoNot recruiting6 YearsN/ABoth10Phase 1Canada
324NCT02803944September 201427 June 2016Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two YearsLong Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National DatabaseCystic FibrosisDrug: AzithromycinHospices Civils de LyonNot recruiting7 YearsN/ABoth2055N/AFrance
325EUCTR2013-004987-80-BE28/08/20147 October 2014Colistin dosage through blood samples and sputum in Cystic Fibrosis (CF) populationColistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance.Colistin use in Cystic Fibrosis patients
MedDRA version: 16.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: COLISTINEB 2MUI
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Colistineb
CAS Number: 8068-28-8
Other descriptive name: COLISTIMETHATE SODIUM (A COMPONENT)
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 2-
CUB - Hôpital ErasmeAuthorisedFemale: yes
Male: yes
Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326EUCTR2014-000817-30-NL14/08/20148 August 2016Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutationComparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation - TICTAC-studyCystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Ivacaftor/Kalydeco
Pharmaceutical Form: Film-coated tablet
Product Name: Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: curcumin
CAS Number: 458-37-7
Other descriptive name: CURCUMIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Product Name: Genisteine Plus 150 mg cpl formaat 1 18,7 x 6,4 mm 438 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: genistein
CAS Number: 446-72-0
Other descriptive name: GENISTEIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48.5-
University Medical Centre UtrechtNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
327EUCTR2014-002387-32-GB05/08/201420 August 2018Trial of Rosuvastatin for the Prevention of Kidney Toxicity caused by Tobramycin in Children with Cystic FibrosisPhase IIa, Randomised, Controlled, Open-Label Trial of Rosuvastatin for the Prevention of Aminoglycoside-Induced Kidney Toxicity in Children with Cystic Fibrosis - PROteKTAminoglycoside-induced nephrotoxicity
MedDRA version: 18.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0 Level: PT Classification code 10069022 Term: Kidney injury molecule-1 System Organ Class: 10022891 - Investigations
MedDRA version: 18.0 Level: LLT Classification code 10067571 Term: Nephrotoxicity System Organ Class: 100000004857 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: Crestor
Product Name: Crestor
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rosuvastatin calcium
CAS Number: 287714-41-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
University of LiverpoolNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom
328NCT03391414August 20148 January 2018Effects of Inhaled Bicarbonate on Airway pH in Cystic FibrosisEffects of Inhaled Bicarbonate on Airway pH in Cystic FibrosisCystic FibrosisDrug: hypertonic bicarbonate;Drug: sodium chlorideJoseph PilewskiCystic Fibrosis Foundation TherapeuticsNot recruiting12 YearsN/AAll12Phase 1United States
329EUCTR2014-001401-41-NL29/07/201411 August 2014Once daily deep inhalation of tobramycin with smart nebulizer more effective to treat small airways disease in cystic fibrosis?Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis - TAPAS study in patients with CFCystic Fibrosis and chronic infection with Pseudomonas aeruginosa;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Bramitob 300mg/4ml Nebuliser Solution
Pharmaceutical Form: Nebulisation solution
AuthorisedFemale: yes
Male: yes
26Netherlands
330EUCTR2014-000284-40-GB05/06/201410 April 2017Cysteamine in Cystic FibrosisAn open label investigation of the tolerability and pharmacokinetics of oral cysteamine in adults with Cystic Fibrosis. - Cysteamine in Cystic Fibrosis (2)Cystic Fibrosis
MedDRA version: 16.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cystagon (cysteamine bitartrate) immediate-release capsules
Product Name: Cystagon (cysteamine bitartrate) immediate-release capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: cysteamine bitartrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
University of AberdeenNHS GrampianNot RecruitingFemale: yes
Male: yes
12Phase 1;Phase 2United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331NCT01576315June 201425 April 2016ATCF (Azole Therapy in Cystic Fibrosis)Efficacy of Itraconazole and of Voriconazole in Patients With Cystic Fibrosis and Presenting With Persistent Positive Sputums for Aspergillus.Cystic Fibrosis;Aspergillus InfectionsDrug: Itraconazole/voriconazoleRennes University HospitalNot recruiting12 YearsN/ABoth11Phase 2France;United Kingdom
332NCT02139306June 20147 December 2015Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients With Nonsense Mutation Cystic FibrosisCystic FibrosisDrug: Ataluren (PTC124®);Drug: PlaceboPTC TherapeuticsCystic Fibrosis Foundation Therapeutics;European Cystic Fibrosis Society-Clinical Trial Network (ECFS-CTN)Not recruiting6 YearsN/ABoth208Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
333NCT02141191June 201416 December 2017A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD DeviceA Randomized Crossover Mucociliary Clearance Study of Aerosolized 7% NaCl Solution Administered Overnight by the tPAD Device to Subjects With Cystic FibrosisCystic FibrosisDrug: inhaled hypertonic saline (7%)University of PittsburghParion SciencesNot recruiting18 YearsN/AAll12Phase 1United States
334NCT02107859May 31, 20144 February 2019Study of Ataluren (PTC124) in Cystic FibrosisAn Open-Label Safety and Efficacy Study for Patients With Nonsense Mutation Cystic Fibrosis Previously Treated With Ataluren (PTC124)Cystic FibrosisDrug: Ataluren (PTC124)PTC TherapeuticsNot recruiting6 YearsN/AAll61Phase 3United States;Belgium;France;Israel;Italy;Spain;Sweden;Germany
335EUCTR2013-005481-19-DK27/05/201423 May 2016High Dose Antioxidant Treatment for Patients with Cystic FibrosisHigh Dose Antioxidant Treatment for Patients with Cystic FibrosisCystic Fibrosis
MedDRA version: 17.0 Level: LLT Classification code 10068288 Term: Cystic fibrosis pulmonary exacerbation System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Mucolysin
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200-600
Trade Name: Mucomyst
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200-600
Trade Name: ACC
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200-600
Trade Name: Tad
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: GLUTATHIONE
CAS Number: 8000050-16-0
Other descriptive name: GLUTATHIONE SODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Aarhus University HospitalNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT02144246May 201418 January 2016Contraceptive Hormones and Women With Cystic FibrosisContraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on DiseaseCystic Fibrosis Exacerbations While on and Off Hormonal ContraceptionOther: Non-hormonal period;Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mgUniversity of PennsylvaniaSociety of Family PlanningNot recruiting18 Years40 YearsFemale5Phase 1United States
337EUCTR2013-004295-35-AT30/04/201427 October 2014Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept studyLung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUTChronic lung P. Aeruginosa Infection
MedDRA version: 16.1 Level: PT Classification code 10061229 Term: Lung infection System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
Pharmaceutical Form: Powder and solvent for nebuliser solution
INN or Proposed INN: aztreonam
CAS Number: 827611-49-4
Other descriptive name: AZTREONAM LYSINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-75
Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
Pharmaceutical Form: Powder and solvent for nebuliser solution
INN or Proposed INN: COLISTIMETHATE SODIUM
CAS Number: 8068-28-8
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1.000.000-1.000.000
Trade Name: TOBI
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: TOBRAMYCIN SULFATE
CAS Number: 79645-27-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-300
Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)AuthorisedFemale: yes
Male: yes
Austria
338EUCTR2014-000057-37-NL30/04/20148 August 2016Bronchodilcation as a CFTR activator in CFA B2-agonist as a CFTR activator in CF - ABBA studyCystic Fibrosis;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]Product Name: Salbutamol
Product Code: R03AC02
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: SALBUTAMOL
CAS Number: 18559-94-9
Concentration unit: µg microgram(s)
Concentration type: up to
Concentration number: 400-
Product Name: Salbutamol
Product Code: R03CC02
Pharmaceutical Form: Tablet
INN or Proposed INN: SALBUTAMOL
CAS Number: 18559-94-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
University Medical Centre UtrechtNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
339EUCTR2013-005366-19-GB29/04/20143 April 2017A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 16.1 Level: LLT Classification code 10057582 Term: Lung infection pseudomonal System Organ Class: 100000004862
MedDRA version: 16.1 Level: LLT Classification code 10006446 Term: Bronchiectasis NOS System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Ciprofloxacin Hydrochloride
CAS Number: 86483-48-9
Current Sponsor code: Ciprofloxacin for Inhalation (CFI)
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Ciprofloxacin Hydrochloride
CAS Number: 86483-48-9
Current Sponsor code: Free Ciprofloxacin for Inhalation (FCI)
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Aradigm CorporationNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand
340EUCTR2013-004659-19-DE23/04/201422 May 2017Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2non-CF bronchiectasis
MedDRA version: 19.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Ciprofloxacin
Current Sponsor code: BAYq3939
Other descriptive name: CIPROFLOXACIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 32.5-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Bayer AGNot RecruitingFemale: yes
Male: yes
492Phase 3Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2013-004659-19-NL23/04/20145 December 2016Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2non-CF bronchiectasis
MedDRA version: 19.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Ciprofloxacin
Current Sponsor code: BAYq3939
Other descriptive name: CIPROFLOXACIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 32.5-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Bayer AGNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
342NCT01515007April 201429 January 2018Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)Non Cystic Fibrosis BronchiectasisDrug: Ciprofloxacin dispersion for inhalation;Drug: PlaceboAradigm CorporationGrifols Therapeutics Inc.Not recruiting18 YearsN/AAll278Phase 3United States;Australia;Canada;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Poland;Romania;South Africa;Spain;Taiwan;United Kingdom;New Zealand
343NCT01991028April 201419 February 2015A Study to Investigate Lung Deposition of Radiolabelled OligoGAn Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis PatientsCystic FibrosisDrug: Radiolabelled OligoG CF-5/20 DPI;Drug: Radiolabelled OligoG CF-5/20 6% SolutionBio-Images Research LtdAlgiPharma ASNot recruiting18 YearsN/ABoth10Phase 2United Kingdom
344NCT02057458April 201421 January 2019Blood Flow and Vascular Function in Cystic FibrosisRole of Blood Flow and Vascular Function on Exercise Capacity in Cystic FibrosisCystic FibrosisDrug: Acute (1 hour) Sildenafil;Drug: Sub-Chronic (4 weeks) Sildenafil;Drug: PlaceboAugusta UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting18 YearsN/AAll50Phase 2United States
345NCT02113397April 201411 June 2018Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis LungComparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled ColistimethateCystic FibrosisDrug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times dailyDartmouth-Hitchcock Medical CenterNovartis PharmaceuticalsNot recruiting12 Years75 YearsAll1N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346NCT02141958April 201421 July 2016Safety Study of Fenretinide in Adult Patients With Cystic FibrosisAn Adaptive Phase I Intra-patient Dose Escalation Study of Fenretinide in Adult Cystic Fibrosis PatientsCystic FibrosisDrug: Fenretinide;Drug: PlaceboElias MatoukNot recruiting18 YearsN/ABoth15Phase 1Canada
347NCT03341741March 11, 201416 December 2017Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF PatientsCombined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF PatientsCystic Fibrosis With Pulmonary ManifestationsDrug: Tobramycin Powder;Drug: ColistinUniversity Hospital TuebingenNot recruiting12 YearsN/AAll26Phase 3
348NCT02070744March 201411 June 2018Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label ExpansionA Phase 2, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 in Combination With Ivacaftor for 12 Weeks in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation With an Open-Label ExtensionCystic FibrosisDrug: VX-661;Drug: Ivacaftor;Drug: Placebo matched to VX-661;Drug: Placebo matched to IvacaftorVertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll40Phase 2United States
349NCT02081963March 201429 April 2019Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis BronchiectasisA Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis BronchiectasisNon-Cystic Fibrosis BronchiectasisDrug: Amikacin;Drug: Normal salineQilu Hospital of Shandong UniversityNot recruiting18 Years80 YearsAll178Phase 4China
350NCT02084043March 201429 June 2015In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive VentilationIn Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.Respiratory Diseases;Lung Diseases;Cystic Fibrosis;COPD;AsthmaDrug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)University Hospital St Luc, BrusselsUniversité Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, SwitzerlandNot recruitingN/AN/ABoth3N/ABelgium;Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351NCT02088216March 20148 August 2016Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of BronchiectaisisEffect of Long-term, High-dose N-acetylcysteine on Acute Exacerbations of Patients With Non-cystic Fibrosis Bronchiectasis: the BENE Randomized, Controlled TrialNon-Cystic Fibrosis BronchiectasisDrug: N-acetylcysteine;Drug: PlaceboQilu HospitalNot recruiting18 Years80 YearsBoth150Phase 4China
352NCT02148978March 201419 February 2015Cystic Fibrosis Related DiabetesDPP-IV Inhibition in Patients With Cystic FibrosisCystic FibrosisDrug: SaxagliptinRam WeissRecruiting18 Years65 YearsBoth30N/AIsrael
353NCT01746784February 201419 October 2017Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR MutationA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of N6022 to Evaluate Safety and Pharmacokinetics in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation (SNO1)Cystic FibrosisDrug: N6022;Drug: Normal salineNivalis Therapeutics, Inc.Not recruiting18 YearsN/AAll66Phase 1United States
354NCT01937325February 20148 August 2016CPET in CF Patients With One G551D Mutation Taking VX770Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor)Cystic FibrosisDrug: ivacaftor;Drug: placeboThe AlfredNot recruiting16 Years70 YearsBoth20Phase 4Australia
355EUCTR2013-004488-30-NL31/01/201410 February 2014Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CFCystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Bramitob
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: TOBRAMYCIN
CAS Number: 32986-56-4
Current Sponsor code: TAPAS-PK-2014
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 600-
Haga HospitalAuthorisedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356EUCTR2013-000604-41-IT21/01/201413 June 2016A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 83-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: ivacaftor 125mg tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
357EUCTR2013-003774-27-GB20/01/20143 April 2017A study to investigate lung deposition of radiolabelled OligoG(v1.0)An open label, randomised, two-way crossover scintigraphic study to investigate lung deposition of radiolabelled OligoG delivered as a dry powder and as a nebulised solution in cystic fibrosis patients - A study to investigate lung deposition of radiolabelled OligoG (v1.0)Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI)
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: OligoG
CAS Number: 9005-38-3
Current Sponsor code: OligoG CF-5/20
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 96-
Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: OligoG
CAS Number: 9005-38-3
Current Sponsor code: OligoG CF-5/20
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
AlgiPharma ASNot RecruitingFemale: yes
Male: yes
12Phase 2United Kingdom
358NCT02015507January 201419 February 2015An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With IvacaftorAn Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on the Multiple-Dose Pharmacokinetics of Ivacaftor and on the Multiple-Dose Pharmacokinetics of VX-661 Administered in Combination With IvacaftorCystic FibrosisDrug: ivacaftor;Drug: VX-661;Drug: ciprofloxacinVertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsBoth34Phase 1
359NCT02015663January 201416 December 2017Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off CyclesA 24-week, Open-label, Parallel-group, Interventional Phase IV Study Comparing Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles for the Treatment of Pulmonary Pseudomonas Aeruginosa in Patients With Cystic FibrosisCystic FibrosisDrug: Tobramycin Inhalation PowderNovartis PharmaceuticalsNot recruiting6 YearsN/AAll32Phase 4United States
360NCT02043717January 201416 December 2017Increased Vitamin D Reduces Pulmonary Exacerbations in CFIncreasing Vitamin D Serum Levels Reduces Pulmonary Exacerbations in Patients With Cystic FibrosisCystic FibrosisDietary Supplement: Vitamin DHadassah Medical OrganizationNot recruiting4 YearsN/AAll90N/AIsrael
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361EUCTR2014-003023-22-FR2 October 2017Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study)Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) - AZI-STOP studybronchiectasis excluding cystic fibrosis in children;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: ZITHOMAX 40 mg/ml ENFANTS
Product Name: zithromax
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
Current Sponsor code: azithromycine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 41,92-
Trade Name: ZITHROMAX 250 mg
Product Name: ZITHROMAX
Pharmaceutical Form: Tablet
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
Current Sponsor code: azithromycine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 262-
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLENot AvailableFemale: yes
Male: yes
Phase 3France
362EUCTR2014-003882-10-FR2 October 2017Evaluation of the efficacy of antibiotic treatments associated with the Nebcine® as intravenous injection only and / or monitoring of aerosols of Tobi® in order to optimize the therapeutic management of exacerbations in patients with cystic fibrosis .Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) associated with only 5 days of tobramycin ( Nebcine® ) by intravenous injection followed tobramycin aerosol ( Tobi® ) for 9 days in the context of cystic fibrosismucoviscidosis or cystic fibrosis
MedDRA version: 18.0 Level: LLT Classification code 10068288 Term: Cystic fibrosis pulmonary exacerbation System Organ Class: 100000004862 ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: NEBCINE
Product Name: NEBCINE
Pharmaceutical Form: Solution for injection
CAS Number: 32986-56-4
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: NEBCINE
Product Name: NEBCINE
Pharmaceutical Form: Solution for injection
CAS Number: 32986-56-4
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-0
Trade Name: NEBCINE
Product Name: NEBCINE
Pharmaceutical Form: Solution for injection
CAS Number: 32986-56-4
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: NEBCINE
Product Name: NEBCINE
Pharmaceutical Form: Solution for injection
CAS Number: 32986-56-4
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: TOBI
Product Name: TOBI
Pharmaceutical Form: Nebuliser solution
CAS Number: 32986-56-4
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
CHRU de LilleNot AvailableFemale: yes
Male: yes
Phase 2France
363NCT01946412December 201319 October 2017Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating MutationA Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsNot recruiting2 YearsN/AAll33Phase 3United States;Canada;United Kingdom
364NCT01958944December 201313 June 2016Evaluation of the Safety and Tolerability of Inhaled Nitric Oxide to Subjects With Cystic FibrosisPhase II Prospective, Open Labeled, Multi-Center, Evaluation of the Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Cystic FibrosisCystic FibrosisDrug: Nitric oxideAdvanced Inhalation Therapies LtdSoroka University Medical Center;Schneider Children's Medical Center, IsraelNot recruiting10 YearsN/ABoth9Phase 1/Phase 2Israel
365NCT01975259December 201314 September 2015Investigating the Incretin Effect in Cystic FibrosisInvestigating the Incretin Effect in Cystic FibrosisCystic FibrosisDrug: Oral Glucose Tolerance test (75g 2-hour);Drug: Modified Oral Glucose Tolerance Test (50g 4-hours);Drug: Matched isoglycemic clamp;Drug: Hyperglycemic clamp with concurrent GLP-1 infusion;Drug: Hyperglycemic Clamp with concurrent GIP infusion;Drug: Hyperglycemic clamp with placebo infusion;Other: Liquid Meal Test (Carbohydrate-rich);Other: Liquid Meal Test (Fat-rich);Other: Liquid Meal Test (Mixed);Device: Continuous Glucose MonitoringLiverpool Heart and Chest Hospital NHS Foundation TrustNot recruiting17 Years50 YearsBoth50N/AUnited Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366NCT02036879December 201311 February 2019Gender Disparity and Hormones in Cystic FibrosisGender Disparity and Hormones in Cystic FibrosisCystic Fibrosis (CF)Drug: Loestrin (norethindrone acetate and ethinyl estradiol)University of Texas Southwestern Medical CenterNot recruiting18 YearsN/AAll55N/AUnited States
367NCT02096315December 201316 December 2017Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.A Phase II, Open-label, Multicenter Study to Assess the Tolerance, Safety, Efficacy and Pharmacokinetics/Pharmacodynamics (PK/PD) of POL7080 in the Treatment of Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis Due to Pseudomonas Aeruginosa Infection Requiring Intravenous TreatmentBronchiectasis;Lower Respiratory InfectionDrug: POL7080Polyphor Ltd.Not recruiting18 Years79 YearsAll20Phase 2Spain;United Kingdom
368EUCTR2013-002819-10-HU29/11/201327 October 2014A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic FibrosisA Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic FibrosisPancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON N 25000
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not applicable
CAS Number: 8049-47-6
Current Sponsor code: CREON N
Other descriptive name: PANCREATIN
Concentration unit: IU/kg international unit(s)/kilogram
Concentration type: equal
Concentration number: 25000-
Trade Name: Creon 25000
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not assigned
CAS Number: 8049-47-6
Other descriptive name: PANCREATIN
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 25000-
Abbott Laboratories GmbHNot RecruitingFemale: yes
Male: yes
40Hungary;Spain;Russian Federation
369NCT00924547November 20133 August 2015Oral Docosahexanoic Acid Supplementation in Cystic FibrosisOral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in PlasmaCystic FibrosisDietary Supplement: Docosahexanoic Acid Supplement;Dietary Supplement: PlaceboVanderbilt UniversityNot recruiting6 YearsN/ABoth17Phase 2United States
370NCT01702415October 20132 November 2015Zoledronic Acid in Cystic FibrosisRandomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis.Cystic FibrosisDrug: Zoledronic acid;Drug: PlaceboPapworth Hospital NHS Foundation TrustNovartis PharmaceuticalsNot recruiting18 YearsN/ABoth0Phase 4United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371NCT01784419October 201319 February 2015Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis PatientsShort Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis PatientsCystic FibrosisDrug: ivacaftorUniversity of California, San FranciscoRecruiting6 YearsN/ABoth30N/AUnited States
372NCT01880346October 20137 December 2015Comparison of Absorption of Vitamin D in Cystic FibrosisVehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs OilCystic FibrosisDietary Supplement: Vitamin D Powder;Dietary Supplement: Vitamin D OilEmory UniversityNot recruiting18 Years59 YearsBoth17Phase 4United States
373NCT01931839October 201316 December 2017A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic FibrosisA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationDrug: Lumacaftor Plus Ivacaftor Combination;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll1164Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
374NCT02035488October 201319 February 2015Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis BronchiectasisPharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis BronchiectasisBronchiectasisDrug: TobramycinUniversity Medical Centre GroningenNot recruiting18 YearsN/ABoth8Phase 1/Phase 2Netherlands
375EUCTR2013-001258-82-IT12/09/201318 January 2016Phase II clinical study for the therapy of cystic fibrosis patients with a specific mutationA phase II pilot clinical study of experimental research to evaluate the functional rescue of CFTR protein through proteostasis regulators - Proteostasis regulators effect in cystic fibrosis therapyCystic fibrosis patients with F508del-CFTR in homozygous or compound heterozygous with Class I or II mutations;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]Trade Name: Cystagon
Product Name: Cysteamine bitartrate (Cystagon)
Product Code: EMEA/H/C/000125
Pharmaceutical Form: Capsule
European Institute for Cystic Fibrosis Research (IERFC)Not RecruitingFemale: yes
Male: yes
Phase 2Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376EUCTR2013-002202-31-GB11/09/201314 April 2014Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: POL7080
Product Code: POL7080
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: POL7080
CAS Number: 944252-63-5
Current Sponsor code: POL7080
Other descriptive name: POL7080
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 7.5-
Polyphor Ltd.AuthorisedFemale: yes
Male: yes
20Phase 2Spain;United Kingdom
377NCT01944735September 201316 March 2015Phase 1 Study Assessing the Safety and Tolerability of CTX-4430 in Cystic Fibrosis PatientsA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTX-4430 When Administered Orally to Cystic Fibrosis Patients for Fifteen DaysCystic FibrosisDrug: CTX-4430;Drug: PlaceboCeltaxsys, Inc.CelerionNot recruiting18 Years55 YearsBoth17Phase 1United Kingdom
378NCT01953367September 201319 February 2015Bioequivalence and Safety of Vantobra and TOBI in Healthy SubjectsBioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy SubjectsCystic FibrosisDrug: Vantobra (tobramycin);Drug: TOBI (tobramycin)Pari Pharma GmbHNot recruiting18 Years50 YearsBoth72Phase 1Germany
379NCT02048592September 201319 February 2015Impact of Immunonutrition on the Patients With Cystic FibrosisImpact of Immunonutrition on the Patients With Cystic FibrosisCystic Fibrosis;Malnutrition;Oxidative StressDietary Supplement: Impact-Nutridrink;Dietary Supplement: Nutridrink-ImpactUniversity Hospital, MotolRecruiting18 Years40 YearsBoth30Phase 4Czech Republic
380NCT02288429September 201315 July 2019Evaluation of Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate SodiumEvaluation of Steady-state Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate Sodium in Cystic Fibrosis and Critically Ill PatientsColistinDrug: colistimethate sodiumUniversity of Colorado, DenverNot recruiting18 Years89 YearsAll16Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
381NCT01885169August 201319 February 2015LAIV (Flumist®) Administration in CF PatientsSafety of Live-attenuated Influenza Vaccine (LAIV, Flumist®) in Patients With Cystic Fibrosis (CF)Cystic FibrosisBiological: Flumist®McGill University Health CenterMinistere de la Sante et des Services Sociaux;Canadian Cystic Fibrosis Foundation;PHAC/CIHR Influenza Research NetworkNot recruiting2 Years18 YearsBoth170N/ACanada
382NCT01916577August 201319 February 2018Autologous CD117+ Progenitor Cell Mobilization for Lung TransplantationAutologous CD117+ Progenitor Cell Mobilization for Lung TransplantationCOPD;Cystic Fibrosis;Pulmonary FibrosisDrug: Plerixafor mobilization of autologous CD117 stem cellsUniversity of Colorado, DenverSanofiNot recruiting18 Years70 YearsAll15Phase 1United States
383EUCTR2012-000386-20-GB31/07/201328 September 2015A Roll-over study in children with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term safety and pharmacodynamics of ivacaftorA Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutationcystic fibrosis
MedDRA version: 18.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
Pharmaceutical Form: Granules
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
35Phase 3United States;Canada;United Kingdom
384EUCTR2013-000219-25-IT18/07/201330 April 2018MRSA study.Early eradication of S. Aureus (MRSA) in patients with cystic fibrosis: a randomized multicenter study.Patients affected by cystic fibrosis and who present an initial infection of MRSA.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: Rifampin
Pharmaceutical Form: Tablet
INN or Proposed INN: RIFAMPICIN
CAS Number: 13292-46-1
Product Name: Trimethoprim-sulfamethoxazole
Pharmaceutical Form: Tablet
INN or Proposed INN: SULFAMETHOXAZOLE
CAS Number: 723-46-6
Other descriptive name: TRIMETHOPRIM
Product Name: minocycline
Pharmaceutical Form: Tablet
CAS Number: 13614-98-7
Other descriptive name: MINOCYCLINE HYDROCHLORIDE
AOU MeyerAuthorisedFemale: yes
Male: yes
100Phase 3Italy
385NCT01155752July 201316 December 2017Pulmozyme in Cystic Fibrosis With SinusitisZ4770s, Use of Recombinant Human DNASE in Cystic Fibrosis Patients With Chronic Sinusitis to Prevent Acute Sinusitis Exacerbations and Improve Symptoms and Outcomes - A Pilot StudySinusitis;Cystic FibrosisDrug: Pulmozyme single use ampule;Drug: placeboMilton S. Hershey Medical CenterGenentech, Inc.Not recruiting12 Years65 YearsAll0Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
386NCT01897233July 201316 December 2017Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: Lumacaftor;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNot recruiting6 Years11 YearsAll62Phase 3United States;Canada
387NCT01899105July 201319 February 2015A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With IvacaftorA Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult SubjectsCystic FibrosisDrug: lumacaftor;Drug: ivacaftorVertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsBoth28Phase 1United States
388EUCTR2012-001565-33-GB21/06/201317 November 2014An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosisChronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 17.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.1 Level: LLT Classification code 10021860 Term: Infection Pseudomonas aeruginosa System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Current Sponsor code: TBM100
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28-
Pharmaceutical Form: Nebulisation solution
INN or Proposed INN: Tobramycin
CAS Number: 3232986-56-4
Current Sponsor code: TBM100
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical Form: Powder and solvent for nebuliser solution
INN or Proposed INN: Colistimethate
CAS Number: 30387-39-4
Other descriptive name: COLISTIMETHATE
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 1-
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
67Phase 4Spain;Germany;Switzerland;United Kingdom
389EUCTR2012-003990-24-DE20/06/201330 June 2014A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 83-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: ivacaftor 125mg tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
390EUCTR2012-003990-24-GB10/06/201328 February 2019A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 83-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: ivacaftor 125mg tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Vertex Pharmaceuticals IncorporatedNot Recruiting Female: yes
Male: yes
501Phase 3France;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
391NCT01859390June 201316 December 2017Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic FibrosisA Multi-Center, Randomized, Controlled, Double-Blind Study of the Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis PatientsCystic FibrosisDrug: AquADEKs-2;Dietary Supplement: control multivitaminUniversity of Colorado, DenverCystic Fibrosis Foundation Therapeutics;Yasoo HealthNot recruiting10 YearsN/AAll73Phase 2United States
392NCT01879228June 201330 September 2019Effect of Chronic Incretin-based Therapy in Cystic FibrosisA Randomized, Double-blind, Placebo Controlled Study of the Effectiveness of Chronic Incretin-based Therapy on Insulin Secretion in Cystic FibrosisCystic Fibrosis;Pancreatic InsufficiencyDrug: SitagliptinUniversity of PennsylvaniaChildren's Hospital of PhiladelphiaNot recruiting18 YearsN/AAll26N/AUnited States
393NCT01887197June 201319 November 2018Repeatability and Response Study of Absorptive Clearance ScansRepeatability and Response Study of Absorptive Clearance ScansCystic FibrosisOther: Absorptive clearance scan;Drug: inhaled hypertonic saline (7%);Drug: mannitol inhalation powderTim CorcoranNot recruiting18 YearsN/AAll24Phase 1United States
394NCT01910415June 201319 February 2015Phase 1, QT/QTC Interval Study in Healthy SubjectsA Phase 1, Randomized, Placebo and Active Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of Lumacaftor in Combination With Ivacaftor on the QT/QTc Interval in Healthy SubjectsCystic FibrosisDrug: Lumacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor;Drug: Ivacaftor Placebo;Drug: moxifloxacin hydrochlorideVertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsBoth200Phase 1Netherlands
395EUCTR2012-004437-16-NL15/05/20133 June 2013Pharmacokinetic evaluation and local tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasisPharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis - Tobra-02Bronchiectasis Lung infections;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Dry powder tobramycin
Product Code: J01GB01
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Tobramycin dry powder
CAS Number: 32986-56-4
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
University Medical Center GroningenAuthorisedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
396EUCTR2012-003989-40-SE07/05/201324 July 2017A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 83-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: ivacaftor 125mg tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
397NCT01710644May 201313 June 2016Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisA Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisPancreatic Insufficiency;Cystic Fibrosis;Digestive System Diseases;Lung Diseases;Respiratory Tract DiseasesDrug: Burlulipase;Drug: Placebo (Caramel in sterile water)Nordmark Arzneimittel GmbH & Co. KGParexelNot recruiting12 YearsN/ABoth35Phase 1/Phase 2United States
398NCT01807923May 201319 October 2017A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis, Homozygous for the F508del CFTR MutationDrug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll559Phase 3United States;Australia;Canada;Czech Republic;France;Germany;Ireland;Italy;Netherlands;Sweden;United Kingdom
399NCT01840735May 201319 February 2015Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CFA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-5737 in Subjects With Cystic FibrosisCystic FibrosisDrug: GS-5737;Drug: PlaceboGilead SciencesNot recruiting18 YearsN/ABoth8Phase 1United States
400NCT01851694May 201323 April 2019Beta-cell Response to Incretin Hormones in Cystic FibrosisDetermination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic FibrosisCystic Fibrosis;Pancreatic InsufficiencyDrug: GLP-1;Drug: GIPUniversity of PennsylvaniaChildren's Hospital of PhiladelphiaRecruiting18 YearsN/AAll45N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
401NCT01852448May 201326 August 2019Genetics of Insulin and Incretins in Cystic FibrosisEvaluation of the Enteroinsular Axis in Cystic FibrosisCystic FibrosisGenetic: Blood or Saliva Sample Collection;Other: Glucose -potentiated arginine (GPA) stimulation testsChildren's Hospital of PhiladelphiaUniversity of PennsylvaniaRecruiting2 YearsN/AAll350Phase 1United States
402NCT01863238May 20135 September 2016An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic FibrosisAn Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic FibrosisCystic FibrosisOther: Ophthalmologic examinations;Drug: Ivacaftor ExposedVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsNot recruiting6 Years11 YearsBoth95N/AUnited States
403NCT01807949April 201319 October 2017A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis, Homozygous for the F508del CFTR MutationDrug: Placebo;Drug: Lumacaftor Plus Ivacaftor Combination;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNot recruiting12 Years65 YearsAll563Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Spain;United Kingdom
404EUCTR2011-003821-93-DE13/03/20136 February 2017A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR MutationA Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR MutationCystic Fibrosis
MedDRA version: 16.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-661
Product Code: VX-661, VRT-893661
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet assigned
Current Sponsor code: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: VX-661
Product Code: VX-661, VRT-893661
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet assigned
Current Sponsor code: VX-661
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
220Phase 2United Kingdom;Germany;Canada;United States
405NCT01746095March 201319 February 2015Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis PatientsA Phase 2, Randomized, Double Blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis PatientsCystic FibrosisDrug: Vancomycin inhalation powder;Drug: Placebo inhalation powderSavara Inc.Synteract, Inc.;Cystic Fibrosis Foundation TherapeuticsNot recruiting12 YearsN/ABoth87Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
406NCT01837355March 201311 June 2018Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic FibrosisModulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1)Pulmonary Inflammation;Cystic Fibrosis;MicrobiotaDietary Supplement: Lactobacillus rhamnosus;Dietary Supplement: PlaceboCantonal Hospital of St. GallenSwiss Federal Institute of Technology;University Hospital Inselspital, BerneRecruiting6 Years20 YearsAll68N/ASwitzerland
407NCT01775137February 201319 October 2017Ext. Long-term Safety Study in CF Patients: Single Arm TIPA 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401.Long-term Safety of TIPDrug: TBM100Novartis PharmaceuticalsNot recruiting6 YearsN/AAll45Phase 4United States;Argentina;Australia;Canada;Germany;Hungary;Italy;Mexico;Spain
408EUCTR2012-004491-18-GB30/01/201311 March 2013Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs.A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis BronchiectasisNon-Cystic Fibrosis Bronchiectasis
MedDRA version: 15.1 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BAY 85-8501
Product Code: BAY 85-8501
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: BAY 85-8501
Other descriptive name: BAY 85-8501
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Bayer HealthCare AGAuthorisedFemale: yes
Male: yes
90Phase 2aSpain;United Kingdom
409EUCTR2012-002699-14-GB28/01/20134 February 2013Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 yearsCystic fibrosis in children aged 6 to 17 years
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bronchitol
Product Name: Bronchitol
Product Code: N/A
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: mannitol
CAS Number: 69-95-8
Current Sponsor code: N/A
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Pharmaxis Ltd.AuthorisedFemale: yes
Male: yes
160Canada;Argentina;United Kingdom
410EUCTR2012-002880-86-GB25/01/20134 February 2013Resting the pancreas in Cystic FibrosisPRESERVING ?ETA-CELLS: ‘RESTING THE PANCREAS’ IN CYSTIC FIBROSISCystic Fibrosis Related Diabetes (CFRD)
MedDRA version: 14.1 Level: LLT Classification code 10022468 Term: Insulin System Organ Class: 100000004848 ;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Levemir FlexPen
Product Name: Levemir FlexPen
Pharmaceutical Form: Solution for injection in pre-filled pen
Liverpool Heart and Chest Hospital NHS TrustAuthorisedFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411NCT00928135January 22, 201311 June 2018Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) SubjectsRandomized Controlled Study of Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Hospitalized Patients With Exacerbation of Cystic FibrosisCystic FibrosisDrug: Xylitol;Drug: SalineJoseph ZabnerNot recruiting12 YearsN/AAll63Phase 1/Phase 2United States
412EUCTR2011-004208-39-DE21/01/20138 August 2016Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1bronchiectasis
MedDRA version: 18.1 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Ciprofloxacin
Current Sponsor code: BAYq3939
Other descriptive name: CIPROFLOXACIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 32.5-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use
Bayer HealthCare AGNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
413NCT01705145January 201319 October 2017Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating MutationA Phase 3, 2-Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are 2 Through 5 Years of Age and Have a CFTR Gating MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsNot recruiting2 Years5 YearsAll35Phase 3United States;Canada;United Kingdom
414NCT01768663January 201319 February 2015A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult SubjectsA Phase 1, Open-Label Study to Examine the Effect of Ciprofloxacin, Itraconazole, and Rifampin on the Pharmacokinetics of Lumacaftor in Combination With Ivacaftor in Healthy Adult SubjectsCystic FibrosisDrug: Lumacaftor;Drug: Ivacaftor;Drug: Ciprofloxacin;Drug: Itraconazole;Drug: RifampinVertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsBoth80Phase 1United States
415EUCTR2012-002503-17-NL21/12/20127 January 2013Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safetyTobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety - TONI study in children with CFCystic fibrosis
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bramitob
Product Name: Bramitob
Product Code: 033841
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: TOBRAMYCIN
CAS Number: 32986-56-4
Current Sponsor code: TONI-2012
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 600 -
Erasmus University Medical CentreAuthorisedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416EUCTR2012-003532-23-HU19/12/201223 February 2015An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisChronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1 Level: LLT Classification code 10021860 Term: Infection pseudomonas aeruginosa System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Current Sponsor code: TBM100
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
120Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
417NCT01641822December 201219 October 2017Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic FibrosisCystic FibrosisDrug: AZLI;Drug: Placebo to match AZLI;Drug: Tobramycin inhalation solutionGilead SciencesNot recruiting6 YearsN/AAll107Phase 3United States
418NCT01695343December 201219 February 2015Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic TreatmentA Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas AeruginosaCystic FibrosisBiological: KB001-A;Drug: Placebo ComparatorKaloBios PharmaceuticalsNot recruiting12 Years50 YearsBoth182Phase 2United States;Australia;Israel;New Zealand
419NCT01712334December 201219 October 2017A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic FibrosisA Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer SystemCystic FibrosisDrug: dornase alfa [Pulmozyme®]Genentech, Inc.Not recruiting6 YearsN/AAll99Phase 4United States
420NCT01684683November 201223 March 2015The Effect of Theophylline in the Treatment of BronchiectasisClinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) BronchiectasisBronchiectasisDrug: Theophylline;Drug: Placebo(for Theophylline)The First Affiliated Hospital of Guangzhou Medical UniversityNot recruiting18 Years70 YearsBoth100Phase 4China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
421NCT01721382November 201220 June 2016Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic FibrosisTreatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.Cystic FibrosisDrug: SitagliptinNemours Children's ClinicNot recruiting13 Years20 YearsBoth6Phase 1United States
422EUCTR2012-000389-39-GB25/10/201228 September 2015Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR MutationA Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutationcystic fibrosis
MedDRA version: 18.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
120Phase 3France;United States;Belgium;United Kingdom
423NCT01316276October 5, 201226 August 2019Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) InfectionLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaCystic FibrosisDrug: Liposomal amikacin for inhalationInsmed IncorporatedNot recruiting6 YearsN/AAll206Phase 3Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;United Kingdom
424NCT01586728October 201229 June 2015Oxygen Therapy in Cystic FibrosisIndication and Benefits of Nocturnal Oxygen Therapy in Cystic FibrosisCystic FibrosisOther: Air - oxygen;Other: Oxygen - AirAssistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseNot recruiting6 YearsN/ABoth8N/AFrance
425NCT01594827October 201222 January 2018Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)Persistent MRSA Eradication Protocol (PMEP)Cystic FibrosisDrug: Inhaled Vancomycin;Drug: Placebo (Sterile Water);Drug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX);Drug: Doxycycline;Drug: Mupirocin Intranasal Creme;Drug: 4% chlorhexidine gluconate liquid skin cleanserJohns Hopkins UniversityCase Western Reserve University;Cystic Fibrosis Foundation TherapeuticsNot recruiting12 YearsN/AAll29Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
426NCT01793649October 201219 February 2015A Phase 1 Study to Characterize the Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) in Healthy SubjectsA Phase 1, Randomized, Double-Blind, Cross-Over, Vehicle-Controlled, Single-Dose Study To Characterize The Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) In Healthy SubjectsCystic Fibrosis;Chronic Obstructive Pulmonary DiseaseDrug: GS-5737Gilead SciencesNot recruiting18 Years45 YearsBoth7Phase 1United States
427ChiCTR-TRC-120024702012-09-1518 April 2017The effect of theophylline in the treatment of bronchiectasis, a random, double blind studyThe effect of theophylline in the treatment of bronchiectasis, a random, double blind study.bronchiectasis not due to cystic fibrosis1:theophylline;2:theophylline;The first affiliated hospital of Guangzhou Medical UniversityNot Recruiting1565Both1:46;2:46;Post-marketChina
428NCT01667094September 201216 December 2017A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic FibrosisContinuous-infusion Anti-pseudomonal ß-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic FibrosisCystic FibrosisDrug: Intermittent, short infusion Ceftazidime;Drug: Continuous infusion Ceftazidime;Drug: Intermittent, short infusion Meropenem;Drug: Continuous infusion Meropenem;Drug: Intermittent, short infusion Ticarcillin-clavulanate;Drug: Continuous infusion Ticarcillin-clavulanate;Drug: Intermittent, short infusion Cefepime;Drug: Continuous infusion Cefepime;Drug: Continuous infusion Piperacillin tazobactam;Drug: Intermittent, short infusion Piperacillin tazobactamThe AlfredNot recruiting18 YearsN/AAll50Phase 4Australia
429NCT01685801September 201219 October 2017Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR FunctionA Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis, Residual CFTR Function, and FEV1 =40% PredictedCystic FibrosisDrug: Ivacaftor;Drug: Placebo-matched-to-ivacaftor tabletVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll24Phase 2United States
430NCT01694069September 201219 February 2015Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic FibrosisContinuous Infusion Piperacillin-Tazobactam for the Treatment of Pulmonary Exacerbations in Patients With Cystic FibrosisCystic FibrosisDrug: Piperacillin-tazobactam combination productWest Virginia UniversityNot recruiting8 YearsN/ABoth6Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431NCT02201082September 20127 September 2015Evaluation of the Timing of the Nebulization Related to the Physiotherapy SessionCystic FibrosisProcedure: Airway clearance technique;Drug: Amikacin nebulizationCliniques universitaires Saint-Luc- Université Catholique de LouvainNot recruiting16 Years50 YearsBoth15N/ABelgium
432NCT01194232August 201219 February 2015Sildenafil Trial in Children and Young Adults With CFRandomized Controlled Study of Sildenafil in Children and Young Adults With Mild to Moderate Cystic Fibrosis Lung DiseaseCystic Fibrosis With Mild to Moderate Lung Disease;CMRI of Lung Perfusion;Lung Perfusion;Lung VascularizationDrug: SildenafilChildren's Hospital Medical Center, CincinnatiNot recruiting8 Years21 YearsBoth0Phase 1/Phase 2United States
433NCT01684410August 201219 October 2017Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic FibrosisA Three Week Dose Escalation, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of 100 mg or 200 mg of Inhaled Alpha-1 HC, Once a Day in Subjects With Cystic Fibrosis.Cystic FibrosisBiological: Alpha-1 HC 100 mg;Biological: Placebo;Biological: Alpha-1 HC 200 mgGrifols Therapeutics Inc.Not recruiting18 YearsN/AAll30Phase 2United States
434NCT01652157July 31, 201224 September 2018Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)Fibrosing ColonopathyBiological: CREON;Biological: ZENPEP;Biological: ULTRESA;Biological: PANCREAZE;Biological: PERTZYE;Biological: other non-sponsor pancreatic enzyme replacement therapy;Other: No pancreatic enzyme replacement therapyAbbVie (prior sponsor, Abbott)Cystic Fibrosis Foundation Therapeutics;Digestive Care, Inc.;Janssen Research & Development, LLC;Forest Research Institute, Inc., an Allergan affiliate;VIVUS, Inc.RecruitingN/A99 YearsAll50Phase 3United States
435NCT02190604July 31, 201215 April 2019Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis PatientsA Randomized, Double Blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Ascending Doses of QBW251 in Healthy Subjects and Multiple Doses in Cystic Fibrosis PatientsCystic FibrosisDrug: Placebo;Drug: QBW251Novartis PharmaceuticalsNot recruiting18 Years65 YearsAll153Phase 1/Phase 2United States;Belgium;France;Germany;Ireland;Romania;United Kingdom;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436EUCTR2012-000388-26-BE23/07/201221 August 2017Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating MutationA Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating MutationCystic Fibrosis
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
40Phase 3France;United States;Belgium
437EUCTR2011-005085-37-GB20/07/20127 October 2014Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.A randomized, double blind placebo-controlled study to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients.cystic fibrosis
MedDRA version: 17.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QBW251
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not assigned
CAS Number: Not assigned
Current Sponsor code: QBW251
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Code: QBW251
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not assigned
CAS Number: Not assigned
Current Sponsor code: QBW251
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
156France;United States;Ireland;Romania;Netherlands;Germany;United Kingdom
438EUCTR2011-005790-23-GB17/07/201228 August 2012Comparison of recovery of adrenal gland function following short and long term steroid treatmentComparison of adrenal recovery following short and long-term glucocorticoid therapy. - Adrenal recovery following short and long-term glucocorticoid therapyAdrenal recovery following long and short term steroid treatment.
MedDRA version: 14.1 Level: LLT Classification code 10066550 Term: Chronic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1 Level: LLT Classification code 10000842 Term: Acute lymphatic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1 Level: LLT Classification code 10008953 Term: Chronic liver disease System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 53-03-2
Current Sponsor code: N/A
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 2.5-
Product Name: Hydrocortisone
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydrocortisone
CAS Number: 50-23-7
Current Sponsor code: N/A
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 5-10
Birmingham Children's Hospital NHS Foundation TrustAuthorisedFemale: yes
Male: yes
60United Kingdom
439NCT01614457July 201219 October 2017Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsNot recruiting6 YearsN/AAll70Phase 3United States;United Kingdom;Ireland
440NCT01614470July 201219 October 2017Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating MutationA Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsNot recruiting6 YearsN/AAll39Phase 3United States;Belgium;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441NCT02014181July 201219 February 2015Flaxseed Modulates Inflammation and Oxidative Stress in CFFlaxseed Modulates Oxidative Stress and Inflammatory Biomarkers in Stable Patients With Cystic Fibrosis and Healthy ControlsCystic Fibrosis;Oxidative Stress;InflammationDietary Supplement: finely ground flaxseed powderUniversity of PennsylvaniaNot recruiting18 Years64 YearsBoth10Phase 1United States
442EUCTR2012-000387-19-GB11/06/201217 March 2014Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis who Have the R117H-CFTR Mutationcystic fibrosis
MedDRA version: 16.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVACAFTOR
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
80Phase 3United States;United Kingdom
443NCT01619657June 201216 December 2017Preventive Inhalation of Hypertonic Saline in Infants With Cystic FibrosisRandomized, Double-blind, Controlled Pilot Study on Safety of Hypertonic Saline as Preventive Inhalation Therapy in Newborns and Infants With Cystic FibrosisCystic Fibrosis Lung DiseaseDrug: 6% Hypertonic Saline (HS), 4mL;Drug: 0.9% Isotonic Saline (IS), 4mLHeidelberg UniversityGerman Center for Lung ResearchNot recruitingN/A4 MonthsAll42Phase 2Germany
444NCT01747330June 201219 October 2017Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine InsufficiencyAn Open Label, Multicenter Study Evaluating Safety and Tolerability of Creon Micro in Pediatric Subjects From at Least One Month to Less Than Four Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisPancreatic Exocrine InsufficiencyDrug: PancreatinAbbott ProductsNot recruitingN/A4 YearsAll40Phase 3Russian Federation
445EUCTR2011-001916-69-NL22/05/201217 June 2013treatment with insulin in patients with cystic fibrosis without diabetesinsulin therapy in non-diabetic adults with cystic fibrosis - insulin in CF without CFRDcystic fibrosis patients without cystic fibrosis related diabetes;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Trade Name: Lantus 100 units/ml solution for injection in a cartridge
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
HagaZiekenhuis, pulmonary departmentNot RecruitingFemale: yes
Male: yes
40Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446NCT01270074April 20129 May 2016Prevention of Bronchiectasis in Infants With Cystic FibrosisA Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis.Cystic Fibrosis;BronchiectasisDrug: Azithromycin;Drug: Placebo controlQueensland Children's Medical Research InstituteTelethon Kids InstituteRecruiting6 Weeks6 MonthsBoth130Phase 3Australia;New Zealand
447NCT01572194April 201211 June 2018Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC)Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.Lung Transplantation;Cystic Fibrosis;Renal FailureBiological: Urinary levels of PIIINP as a marker of changes in renal functionNantes University HospitalNot recruiting18 YearsN/AAll45N/AFrance
448EUCTR2011-004761-33-GB08/03/201228 February 2019Repeated application of gene therapy in patients with cystic fibrosisA randomised double-blind placebo-controlled Phase 2B clinical trial of repeated application of gene therapy in patients with cystic fibrosis - Repeated application of gene therapy in patients with CF v01-010204Cystic fibrosis
MedDRA version: 20.0 Level: PT Classification code 10011763 Term: Cystic fibrosis lung System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: pGM169/GL67A
Pharmaceutical Form: Inhalation solution
Other descriptive name: pGM169/GL67A
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 2.5-2.8
Pharmaceutical form of the placebo: Inhalation solution
Route of administration of the placebo: Inhalation use
Imperial CollegeNot Recruiting Female: yes
Male: yes
130Phase 2United Kingdom
449NCT01417481March 201219 October 2017Effect of Glycine in Cystic FibrosisEvaluation of the Capability of a Glycine Oral Supplement for Diminishing Bronchial Inflammation in Children With Cystic FibrosisCystic FibrosisDietary Supplement: Glycine;Dietary Supplement: PlaceboInstituto Nacional de Enfermedades RespiratoriasHospital Infantil de Mexico Federico Gomez;Instituto Mexicano del Seguro SocialNot recruiting5 Years15 YearsAll13Phase 2Mexico
450NCT03045198March 201220 August 2018Effect of Azithromycin on Fatty Acids in CFEffect of Azithromycin on Lipoproteins and Docosahexaenoic Acid in Patients With Cystic FibrosisCystic FibrosisDrug: AzithromycinUniversity Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn)University Hospital, Frankfurt;University of BonnRecruiting10 Years60 YearsAll20Phase 4
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
451NCT01315678February 29, 201215 July 2019Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa InfectionsRandomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaPseudomonas Aeruginosa InfectionDrug: Tobramycin inhalation solution using a PARI LC® Plus nebulizer.;Drug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.Insmed IncorporatedNot recruiting6 YearsN/AAll302Phase 3Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;Sweden;United Kingdom
452NCT01429259February 201219 October 2017Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) ChildrenAn Open Label Study to Assess the Population Pharmacokinetics, Safety, and Practicality of Administering Meropenem as a Prolonged Infusion to Cystic Fibrosis Children Admitted With an Acute Pulmonary ExacerbationCystic Fibrosis;Pneumonia;Pseudomonas Aeruginosa InfectionDrug: meropenemJoseph KutiThrasher Research FundNot recruiting6 Years17 YearsAll30Phase 4United States
453NCT01531673February 201211 June 2018Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) MutationA Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: VX-661;Drug: Ivacaftor;Drug: Placebo matched to VX-661;Drug: Placebo matched to ivacaftorVertex Pharmaceuticals IncorporatedNot recruiting12 YearsN/AAll194Phase 2United States;Canada;Germany;United Kingdom
454NCT01543191February 201219 February 2015A Safety and Tolerability Study OF PUR118 In Subjects With Cystic FibrosisA Phase 1 Dose-escalation Study TO Evaluate the Safety and Tolerability of PUR118 and Placebo in Subjects With CFCystic FibrosisDrug: PUR118Pulmatrix Inc.CelerionNot recruiting18 Years55 YearsBoth10Phase 1United Kingdom
455NCT01509339January 201219 February 2015Pharmacokinetics of Vancomycin for Inhalation in Cystic FibrosisPharmacokinetics of Vancomycin for Inhalation in Cystic FibrosisCystic Fibrosis;Methicillin-resistant Staphylococcus AureusDrug: VancomycinCase Western Reserve UniversityCystic Fibrosis Foundation TherapeuticsNot recruiting18 YearsN/ABoth10Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456NCT01731015January 201219 February 2015Imaging Lung Function Using Oxygen Enhanced MRIA Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast AgentCOPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways DiseaseDrug: Medical Grade OxygenHal C CharlesNot recruiting18 Years90 YearsBoth15Phase 1United States
457NCT02128984January 201229 July 2019Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished ChildrenClinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished ChildrenCystic Fibrosis;Failure to Thrive;MalnutritionDietary Supplement: Symbiotic Formula with DHA and antioxidants;Dietary Supplement: Standard FormulaLaboratorios OrdesaQuantum Experimental;Peruvian Clinical ResearchNot recruiting1 YearN/AAll109N/APeru;Spain
458EUCTR2011-002719-27-IT30/12/201127 January 2014EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUSGLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS - RH-IGF-I IN CYSTIC FIBROSISPATIENTS WITH CYSTIC FIBROSIS
MedDRA version: 14.1 Level: PT Classification code 10011766 Term: Cystic fibrosis pancreatic System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: INCRELEX*SC 1FL 4ML 10MG/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MECASERMIN
CAS Number: 68562-41-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
AZIENDA OSPEDALIERA DI PARMANot RecruitingFemale: yes
Male: yes
20Italy
459NCT01404234December 201119 October 2017Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower AirwaysOpen-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower AirwaysCystic Fibrosis;Pseudomonas AeruginosaDrug: AZLIGilead SciencesNot recruitingN/A12 YearsAll61Phase 3United States;France;Germany;Italy;Poland;Spain
460EUCTR2011-002000-32-HU25/11/20113 February 2014A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisPseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0 Level: LLT Classification code 10021860 Term: Infection pseudomonas aeruginosa System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler 28 mg inhalációs por, kemény kapszula
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tobramycin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
150Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461NCT00889434November 1, 201116 December 2017Efficacy and Safety Study of EGCG/Tocotrienol in 18 Patients With Splicing-mutation-mediated Cystic Fibrosis (CF)Single-site, Open-label, Dose-ranging, Efficacy, and Safety Study of EGCG/Tocotrienol in 18 Patients With Splicing-mutation-mediated CFCystic FibrosisDietary Supplement: ECGC;Dietary Supplement: Tocotrienol;Dietary Supplement: EGCG + TocotrienolHadassah Medical OrganizationNot recruiting18 YearsN/AAll7N/AIsrael
462NCT01537666November 201119 October 2017Inhaled Vancomycin Tolerability, Safety and PharmacokineticsPhase I, Reference-controlled, Dose Escalating Study to Examine the Pharmacokinetics and Safety of AeroVanc Inhalation Powder.Healthy;Cystic FibrosisDrug: AeroVanc;Drug: IV vancomycin hydrochlorideSavara Inc.INC Research LimitedNot recruiting18 Years50 YearsAll25Phase 1Australia
463NCT02276898November 20111 June 2015A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance IndexA Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index as a Short-term Pharmacodynamic Biomarker in Patients With Cystic Fibrosis.Cystic FibrosisDrug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo)The Hospital for Sick ChildrenNot recruiting6 Years18 YearsBoth24Phase 2Canada
464EUCTR2011-006171-19-IT27/10/20113 July 2012Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old.randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old.Cystic fibrosis patients with early P.aeruginosa infection.
MedDRA version: 14.1 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: CIPROXIN*6CPR RIV 500MG
Pharmaceutical Form: Tablet
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: BRAMITOB*NEBUL 56F 300MG/4ML
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
CAS Number: 32986-56-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: CIPROXIN*6CPR RIV 500MG
Pharmaceutical Form: Tablet
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
CAS Number: 86483-48-9
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 750-
Trade Name: PROMIXIN*NEBUL 30MONOD 1MUI
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: COLISTIN MESILATE SODIUM
CAS Number: 2680-63-9
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 1000000-
AZIENDA OSPEDALIERA MEYERAuthorisedFemale: yes
Male: yes
Italy
465EUCTR2011-001821-26-IT18/10/201128 August 2012Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosisAerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis: pilot study of antimicrobial activityAdult patient with cystic fibrosis
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: BRAMITOB*NEBUL 28F 300MG/4ML
Pharmaceutical Form: Nebuliser liquid
INN or Proposed INN: TOBRAMYCIN
CAS Number: 32986-56-4
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 300-
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANONot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
466NCT01002534October 20114 March 2019Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients?Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind, Placebo-controlled Study.Cystic FibrosisDrug: Vardenafil;Drug: PlaceboCliniques universitaires Saint-Luc- Université Catholique de LouvainNot recruiting14 YearsN/AAll5Phase 2Belgium
467NCT01426256October 201116 December 2017Vitamin D for Enhancing the Immune System in Cystic Fibrosis (DISC Study)Vitamin D for Enhancing the Immune System in Cystic FibrosisCystic Fibrosis;Respiratory Tract InfectionsDietary Supplement: CholecalciferolEmory UniversityCystic Fibrosis Foundation TherapeuticsNot recruiting16 YearsN/AAll91Phase 3United States
468NCT01537614October 201124 October 2016Pharmacokinetic Study of Aerosolized Colimycin in Cystic FibrosisCystic FibrosisDrug: COLIMYCINE inhalation;Drug: COLIMYCINE injectablePoitiers University HospitalNot recruiting18 YearsN/ABoth7Phase 1France
469NCT01783613October 201116 December 2017Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic FibrosisStudy of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic FibrosisCystic FibrosisDietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months;Dietary Supplement: Placebo: 50 mg/kg/day during 12 monthsFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalNot recruiting2 Months100 YearsAll96N/ASpain
470EUCTR2011-000801-39-DE31/08/20116 November 2017Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgYCystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 17.1 Level: LLT Classification code 10011764 Term: Cystic fibrosis NOS System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
Pharmaceutical Form: Gargle
INN or Proposed INN: IgY
Current Sponsor code: PsAer IgY
Concentration unit: ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
Concentration type: not less then
Concentration number: 5-
Pharmaceutical form of the placebo: Gargle
Route of administration of the placebo: Oromucosal use
Mukoviszidose Institute gGmbHNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
471NCT01375049August 201119 October 2017Aztreonam Lysine for Pseudomonas Infection Eradication StudyOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA)Cystic FibrosisDrug: Aztreonam for Inhalation Solution (AZLI)Gilead SciencesNot recruiting3 Months17 YearsAll105Phase 2United States;Austria;Belgium;France;Germany;Italy;Netherlands;Poland;Spain;Ireland
472NCT01772758August 201115 July 2019Cystic Fibrosis and Endothelial Function: At Rest and During ExerciseInfluence of Cystic Fibrosis on Vascular Endothelial Function at Rest and During ExerciseCystic FibrosisDrug: BH4 5mg;Drug: BH4 20mg;Dietary Supplement: Antioxidant CocktailAugusta UniversityNot recruiting7 YearsN/AAll64Phase 2United States
473EUCTR2011-000130-11-IT25/07/201127 January 2014Clinical trials in rare diseases: therapeutic alternative to the use of oral corticosteroids in patients with cystic fibrosis underwent double lung transplantation.Clinical trials in rare diseases: therapeutic alternative to the use of oral corticosteroids in patients with cystic fibrosis underwent double lung transplantation.Double lung transplantation in patients with Cystic Fibrosis
MedDRA version: 14.1 Level: PT Classification code 10011763 Term: Cystic fibrosis lung System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1 Level: PT Classification code 10025127 Term: Lung transplant System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Dexamethasone sodium phosphate 250 mg/10 ml solution
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dexamethasone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 500-
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMAAuthorisedFemale: yes
Male: yes
Italy
474NCT01381289June 201119 February 2015VX-770 Expanded Access ProgramVX-770 Expanded Access Program (EAP)Cystic FibrosisDrug: VX-770Vertex Pharmaceuticals IncorporatedNot recruiting6 YearsN/ABothN/A
475NCT01755455June 201116 December 2017Does a Daily Iron Tablet Improve Anemia in Cystic FibrosisIron Supplementation for the Hypoferremic Anemia of Cystic FibrosisCystic Fibrosis;Anemia, Iron-DeficiencyDrug: Ferrous sulfate 325mg;Drug: PlaceboDartmouth-Hitchcock Medical CenterNot recruiting18 Years70 YearsAll22N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
476NCT02782312June 201113 June 2016Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis BronchiectasisSalmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis With Airway Limitation: a Prospective StudyBronchiectasisDrug: ICS+LABA;Other: routine therapyShanghai Pulmonary Hospital, Shanghai, ChinaNot recruiting18 YearsN/ABoth120Phase 4China
477NCT01207245May 20113 August 2015Circadian Rhythm In Tobramycin Elimination In Cystic FibrosisCircadian Rhythm In Tobramycin Elimination In Cystic Fibrosis (CRITIC) A Randomized Pharmacokinetic Comparison of Tobramycin in Cystic FibrosisCystic FibrosisOther: Tobramycin time of administrationUniversity of NottinghamNot recruiting5 YearsN/ABoth18Phase 4United Kingdom
478NCT01355796May 201110 September 2018Inhaled Xylitol Versus Saline in Stable Subjects With Cystic FibrosisRandomized Cross Over Study of Inhaled Hypertonic Xylitol Versus Hypertonic Saline in Stable Subjects With Cystic FibrosisCystic FibrosisDrug: Xylitol;Drug: Hypertonic salineJoseph ZabnerAnn & Robert H Lurie Children's Hospital of Chicago;Northwestern UniversityNot recruiting16 YearsN/AAll30Phase 1/Phase 2United States
479EUCTR2011-000192-13-GB28/04/201126 June 2012A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) studyA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) studycystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 13.1 Level: PT Classification code 10011763 Term: Cystic fibrosis lung System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 13.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Colobreathe
Product Code: N/A
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Colistimethate sodium
CAS Number: 8068288
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 125-
Forest Laboratories UK Ltd.Not RecruitingFemale: yes
Male: yes
28Germany;United Kingdom;Poland
480NCT01313624April 201119 October 2017Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial InfectionBronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNot recruiting18 YearsN/AAll266Phase 3United States;Australia;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
481NCT01314716April 201119 October 2017Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)BronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNot recruiting18 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
482NCT01315665April 201116 December 2017Effect of Sulforaphane in Broccoli Sprouts on Nrf2 ActivationEvaluation of the Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation, Measures of Oxidative Stress, and Neutrophil Migration to Mucosal Surfaces in Healthy and CF SubjectsCystic FibrosisDietary Supplement: Broccoli sproutsUniversity Hospitals Cleveland Medical CenterCystic Fibrosis Foundation TherapeuticsNot recruiting18 Years49 YearsAll15N/AUnited States
483NCT01337219April 201119 February 2015Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic FibrosisPharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.Cystic FibrosisDrug: TobramycinErempharmaUniversity of Lyon;Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME);Clininfo;Hospices Civils de LyonRecruiting16 YearsN/ABoth36Phase 1/Phase 2France
484NCT01347190April 201119 February 2015Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic FibrosisA Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic FibrosisCystic FibrosisBiological: CR002 Liquid API;Biological: PlaceboCSL BehringNot recruiting18 Years65 YearsBoth25Phase 1Bulgaria;Hungary;Poland;United Kingdom
485NCT01349192April 201116 December 2017Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)Cystic Fibrosis;Methicillin-resistant Staphylococcus AureusDrug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole;Drug: Minocycline;Drug: Mupirocin;Drug: chlorhexidine gluconate oral rinse;Drug: 2% Chlorhexidine solution wipes;Behavioral: Environmental DecontaminationUniversity of North Carolina, Chapel HillCF Therapeutics Development Network Coordinating Center;Seattle Children's Hospital;Washington University School of Medicine;University of Washington;University of Colorado, Denver;Baylor College of Medicine;University of Alabama at Birmingham;Cook Children's Medical Center;University of Michigan;University of Florida;University of Texas Southwestern Medical Center;Children's Hospital Medical Center, Cincinnati;St. Louis Children's HospitalNot recruiting4 Years45 YearsAll47Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
486EUCTR2010-023090-19-GB29/03/201119 March 2012A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosaA double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosisCystic Fibrosis
MedDRA version: 14.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: OligoG (60 mg/ml)
Product Code: OligoG
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: OligoG
CAS Number: 9005-38-3
Current Sponsor code: OligoG
Other descriptive name: OligoG-CF5/20, Alginate oligosaccharide (G-block) fragment
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
AlgiPharma ASAuthorisedFemale: yes
Male: yes
24Phase 2United Kingdom;Ireland
487NCT01315691March 201120 August 2018Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas AeruginosaRandomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaCystic FibrosisDrug: Liposomal amikacin for inhalation;Drug: Placebo for liposomal amikacin for inhalationInsmed IncorporatedNot recruiting6 YearsN/AAll0Phase 3
488NCT02029521March 201119 October 2017Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis PatientsSupplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis for Growth FailureCystic FibrosisDietary Supplement: Oral reduced l-glutathione;Dietary Supplement: PlaceboClark BishopNot recruiting18 Months10 YearsAll47N/AItaly
489EUCTR2010-023529-39-GB18/02/201116 October 2012Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0Cystic FibrosisTrade Name: INOmax 400ppm mol/mol inhalation gas
Product Name: Nitric Oxide
Product Code: NO
Pharmaceutical Form: Inhalation gas
Southampton University Hopsitals NHS TrustNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
490EUCTR2010-020413-90-BE08/02/201117 August 2015Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis
MedDRA version: 16.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lumacaftor
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: Ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
293Phase 2United States;Belgium;Ireland;Australia;Germany;United Kingdom;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
491NCT01229553January 201129 June 2015Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) PatientsEffect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients at the CF Center at SUNY Upstate Medical University, Syracuse, NY.Cystic FibrosisDrug: decolonizationState University of New York - Upstate Medical UniversityNot recruiting2 Months23 MonthsBoth0N/AUnited States
492NCT01270347January 201129 January 2018Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) PatientsPhase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF PatientsCystic FibrosisDrug: MP-376 (Levofloxacin Solution for Inhalation);Drug: TIS (Tobramycin Inhalation Solution)Horizon Pharma USA, Inc.Forest LaboratoriesNot recruiting12 YearsN/AAll267Phase 3United States;France;Germany;Ireland;Israel;United Kingdom
493NCT01280994January 201123 April 2019Hyperpolarized 129Xe MRI for Imaging Pulmonary FunctionHyperpolarized 129Xe MR Imaging of the Lung Function in Healthy Volunteers and Subjects With Pulmonary DiseaseInterstitial Lung Disease;Cystic Fibrosis;Pulmonary Hypertension;NSIP;Alpha 1-Antitrypsin DeficiencyDrug: XenonBastiaan DriehuysRecruiting18 Years80 YearsAll445Phase 1United States
494NCT01494909January 20116 May 2019Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and FunctionDevelopment Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and FunctionCystic FibrosisDietary Supplement: Ensure plusTexas A&M UniversityArkansas Children's Hospital Research Institute;University of ArkansasNot recruiting10 YearsN/AAll31N/AUnited States
495NCT02163681January 201116 December 2017MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and ChildrenHealthy;Cystic Fibrosis (CF);Asthma;Bronchopulmonary Dysplasia (BPD)Drug: Hyperpolarized Helium-3 MRI of the chestUniversity of VirginiaXemed LLCRecruiting4 Months65 YearsAll77N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
496NCT00625703December 201030 September 2019Pharmacokinetics of Linezolid in Children With Cystic FibrosisPharmacokinetics of Linezolid in Children With Cystic FibrosisCystic FibrosisDrug: LinezolidUniversity of Texas Southwestern Medical CenterCystic Fibrosis FoundationNot recruitingN/A18 YearsAll14Phase 2United States
497NCT01100892December 201015 April 2019Cystic Fibrosis - Insulin Deficiency, Early ActionCystic Fibrosis - Insulin Deficiency, Early ActionCystic Fibrosis;DiabetesDrug: Once-daily insulin detemirSydney Children's Hospitals NetworkJohn Hunter Children's Hospital;Lady Cilento Children's Hospital, Brisbane;Women's and Children's Hospital, AdelaideRecruiting5 Years19 YearsAll100Phase 3Australia
498NCT01180634November 201029 January 2018MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic FibrosisA Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis PatientsCystic FibrosisDrug: MP-376 (Levofloxacin solution for Inhalation);Drug: PlaceboHorizon Pharma USA, Inc.Forest LaboratoriesNot recruiting12 YearsN/AAll330Phase 3United States;Australia;Canada;Israel;New Zealand
499NCT01299181November 201019 February 2015A Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis BronchiectasisA Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: AtorvastatinUniversity of EdinburghNHS LothianNot recruiting18 Years75 YearsBoth60Phase 4United Kingdom
500NCT01299194November 201016 December 2017Atorvastatin in Bronchiectasis in Patients With Pseudomonas AeruginosaA Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in Patients With Pseudomonas AeruginosaBRONCHIECTASISDrug: ATORVASTATINUniversity of EdinburghNHS LothianNot recruiting18 Years80 YearsAll32Phase 4United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
501EUCTR2010-020546-96-GB08/10/201025 September 2012Study of the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects with Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted -Cystic Fibrosis
MedDRA version: 14.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Other descriptive name: VRT-813077
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
16Phase 2United States;Canada;United Kingdom
502NCT01161537October 201019 October 2017Study of the Effect of VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging in Subjects With Cystic Fibrosis and the G551D MutationA Phase 2, Single-Blind, Placebo-Controlled Study to Evaluate the Effect of VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging in Subjects With Cystic Fibrosis, the G551D Mutation, and FEV1 =40% PredictedCystic FibrosisDrug: VX-770;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsNot recruiting12 YearsN/AAll13Phase 2United States
503NCT01201434October 201019 February 2015Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic FibrosisThe Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled TrialCystic FibrosisDietary Supplement: Bio-25 probioticSheba Medical CenterNot recruiting5 Years40 YearsBoth12N/A
504NCT01216046October 201019 February 2015Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy SubjectsA Phase 1, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose-Escalation, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy SubjectsCystic FibrosisDrug: VX-809;Drug: VX-770;Drug: VX-809 placebo;Drug: VX-770 placeboVertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsBoth48Phase 1United States
505NCT01225211October 201019 October 2017Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: Lumacaftor;Drug: Ivacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor PlaceboVertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll312Phase 2United States;Australia;Belgium;France;Germany;New Zealand;United Kingdom;Ireland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
506EUCTR2009-012842-21-GB20/09/20104 February 2013Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic FibrosisExocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1 Level: HLGT Classification code 10015674 Term: Exocrine pancreas conditions System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pancreas Powder
CAS Number: 8049-47-6
Other descriptive name: PANCREATIN
Concentration unit: Other
Concentration type: equal
Concentration number: 25000-
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pancreas Powder
CAS Number: 53608-75-6
Current Sponsor code: EUR-1008
Other descriptive name: PANCREASLIPASE
Concentration unit: Other
Concentration type: equal
Concentration number: 25000-
Aptalis Pharma US Inc.AuthorisedFemale: yes
Male: yes
86Bulgaria;Germany;Italy;United Kingdom
507EUCTR2010-020516-11-IT16/09/201019 March 2012EXPERIMENTAL STUDY, RANDOMIZED, OPEN LABEL, TO EVALUATE THE EFFECT OF DOCOSAHEXAENOIC ACID (DHA) SUPPLEMENTATION VERSUS 5-METHYLTETHRAHYDROFOLATE + B12 VITAMIN AND DHA, IN CYSTIC FIBROSIS PATIENTS AND PANCREATIC INSUFFICIENCY - NDEXPERIMENTAL STUDY, RANDOMIZED, OPEN LABEL, TO EVALUATE THE EFFECT OF DOCOSAHEXAENOIC ACID (DHA) SUPPLEMENTATION VERSUS 5-METHYLTETHRAHYDROFOLATE + B12 VITAMIN AND DHA, IN CYSTIC FIBROSIS PATIENTS AND PANCREATIC INSUFFICIENCY - NDCYSTIC FIBROSIS AND PANCREATIC INSUFFICIENCY
MedDRA version: 9.1 Level: PT Classification code 10033628
MedDRA version: 9.1 Level: PT Classification code 10011762
Trade Name: PREFOLIC*30CPR GASTROR 15MG
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Detoxifying agents for antineoplastic treatment
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Trade Name: INDUSIL*OS GTT FL 30MG+FL 15ML
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Cobamamide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONAAuthorisedFemale: yes
Male: yes
Italy
508EUCTR2010-019802-17-PT13/09/20109 October 2012A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. -Cystic Fibrosis Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Pharmaceutical Form: Inhalation vapour, solution
CAS Number: 411207313
Current Sponsor code: Ba 679 Br
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3.124-
Pharmaceutical form of the placebo: Inhalation vapour*
Route of administration of the placebo: Inhalation use
Boehringer Ingelheim FranceNot RecruitingFemale: yes
Male: yes
360Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
509NCT01090908September 201019 February 2015Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. AeruginosaA Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas AeruginosaCystic FibrosisDrug: AntibioticAradigm CorporationNot recruiting6 Years18 YearsBoth0N/A
510NCT01208285September 201019 February 2015Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy SubjectsA Phase 1 Non-Randomized, Open-Label Study to Assess the Safety and Pharmacokinetics of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy SubjectsIn Development for Cystic FibrosisDrug: VX-770Vertex Pharmaceuticals IncorporatedNot recruiting18 Years65 YearsBoth24Phase 1Czech Republic;Slovakia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
511NCT01222273September 201011 June 2018Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary AspergillosisOpen-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary AspergillosisCystic Fibrosis;Allergic Bronchopulmonary AspergillosisDietary Supplement: cholecalciferol (Vitamin D3)University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting12 YearsN/AAll7N/AUnited States
512NCT01223183September 201019 February 2015Absorptive Clearance After Inhaled Osmotics in Cystic FibrosisAbsorptive Clearance After Inhaled Osmotics in Cystic FibrosisCystic FibrosisDrug: hypertonic saline (7%);Drug: isotonic salineUniversity of PittsburghNot recruiting18 YearsN/ABoth20Phase 1United States
513NCT01257464September 201019 February 2015Sitagliptin in Cystic Fibrosis-Related DiabetesThe Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related DiabetesCystic FibrosisDrug: Sitagliptin;Drug: PlaceboUniversity of British ColumbiaNot recruiting19 YearsN/ABoth3Phase 2Canada
514EUCTR2010-018454-13-DE31/08/201019 March 2012A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Cystic fibrosis
MedDRA version: 12.1 Level: PT Classification code 10011762 Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Current Sponsor code: NAL
Other descriptive name: Nacystelyn®
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Product Name: Nacystelyn®
Product Code: NAL
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Current Sponsor code: NAL
Other descriptive name: Nacystelyn®
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Laboratoires SMB S.A.Not RecruitingFemale: yes
Male: yes
552Phase 3Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
515NCT01140451August 31, 201015 April 2019Extension Study of Ataluren (PTC124) in Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124) in Subjects With Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: Ataluren (PTC124)PTC TherapeuticsCystic Fibrosis FoundationNot recruiting6 YearsN/AAll191Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
516EUCTR2009-012997-11-FR25/08/201015 May 2012An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSISTAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSISTCystic Fibrosis
MedDRA version: 12.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Product Name: VX-770
Product Code: VX-770, VRT-8130077
Pharmaceutical Form: Tablet
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Other descriptive name: VRT-813077
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Vertex Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
217Germany;United Kingdom;Czech Republic;France;Ireland
517NCT00782288August 201025 March 2019Phase II Study of Digitoxin to Treat Cystic FibrosisPhase II Study of Digitoxin to Treat Cystic FibrosisCystic FibrosisDrug: digitoxin;Other: placeboNational Jewish HealthNot recruiting18 Years45 YearsAll24Phase 2United States
518NCT01181622August 201019 February 2015A Safety and Tolerability Study of Denufosol in 2-4 Year OldsA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic FibrosisCystic FibrosisDrug: denufosol tetrasodium Inhalation Solution;Drug: 0.9% w/v sodium chloride solutionMerck Sharp & Dohme Corp.Not recruiting2 Years4 YearsBoth25Phase 2United States
519NCT01116089July 201019 February 2015Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS NebulizerPHARMACOKINETIC STUDY OF BRAMITOB® ADMINISTERED FOR INHALATION BY PARI eFLOW® RAPID ELECTRONIC NEBULIZER VS PARI LC® PLUS NEBULIZER COUPLED WITH THE PARI TURBO BOY® N COMPRESSOR IN CYSTIC FIBROSIS PATIENTS INFECTED WITH PSEUDOMONAS AERUGINOSACystic FibrosisDrug: Bramitob® administered by PARI LC® PLUS nebulizer;Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizerChiesi Farmaceutici S.p.A.Not recruiting18 YearsN/ABoth25Phase 1Czech Republic;Moldova, Republic of;Slovakia;Russian Federation
520NCT01131507July 201016 December 2017PR-018: An Open-Label, Safety Extension of Study PR-011A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)Cystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNot recruitingN/A12 MonthsAll15Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
521EUCTR2010-018738-27-DE02/06/20101 April 2013A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic FibrosisA Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic FibrosisCystic fibrosis
MedDRA version: 12.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Product Name: SB-656933 Tablets
Product Code: SB-656933-AAA
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: SB-656933-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: SB-656933 Tablets
Product Code: SB-656933-AAA
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: SB-656933-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
GlaxoSmithKline Research & Development LimitedNot RecruitingFemale: yes
Male: yes
100Germany
522NCT01100606June 201019 October 2017A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of AgeA Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)Cystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNot recruiting1 Month12 MonthsAll15Phase 4United States
523NCT01149005June 201019 February 2015Cystic Fibrosis (CF) Exacerbation and Insulin TreatmentEvaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary ExacerbationCystic Fibrosis;Impaired Glucose Tolerance;Pulmonary ExacerbationDrug: novorapid / humalog short acting insulin;Drug: Novo Rapid Insulin (Novonordisk)Hadassah Medical OrganizationNot recruiting10 YearsN/ABoth30N/AIsrael
524NCT01153542June 201019 February 2015Study of VX-770 on DesipramineAn Open-Label Phase 1 Study to Examine the Effect of VX 770 on Desipramine in Healthy SubjectsIn Development for Cystic FibrosisDrug: VX-770Vertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsBoth24Phase 1United States
525NCT01450267June 201019 February 2015Inhaled Glutathione (GSH) Versus Placebo in Cystic FibrosisRandomized, Single Blind, Controlled Trial of Inhaled Glutathione Versus Placebo in Patients With Cystic FibrosisCystic FibrosisDrug: Inhaled Reduced Glutathione;Drug: Physiological solutionSerafino A. MarsicoFederico II UniversityRecruiting6 Years45 YearsBoth150Phase 3Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
526EUCTR2007-001401-15-DK21/05/20105 December 2016Treatment of patients with cystic fibrosis with N-acetylcysteineTreatment of patients with cystic fibrosis with N-acetylcysteinePatients with cystic fibrosis and chronic Pseudomonas lung infection
MedDRA version: 12.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Trade Name: ACC600Tabs
Product Name: N-acetylcystein
Product Code: R05C B01
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLCYSTEINE
CAS Number: 616-91-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
RigshospitaletNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
527EUCTR2010-019194-15-IT12/05/201019 March 2012Esplorative study to evaluate the tolerability of Amphotericin B lipid complex (Abelcet) by aerosol in patients with Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis (ABPA) - NDEsplorative study to evaluate the tolerability of Amphotericin B lipid complex (Abelcet) by aerosol in patients with Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis (ABPA) - NDCystic Fibrosis and Allergic Bronchopulmonary Aspergillosis (ABPA)
MedDRA version: 9.1 Level: SOC Classification code 10021881
MedDRA version: 9.1 Level: PT Classification code 10011762
Trade Name: ABELCET
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Amphotericin B
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONAAuthorisedFemale: yes
Male: yes
Italy
528NCT00967798May 201029 January 2018Prevention of Cystic Fibrosis DiabetesA Randomized, Double-blind, Placebo-controlled Study to Determine Whether Chronic Treatment of Cystic Fibrosis Subjects With Impaired Glucose Tolerance Using Sitagliptin (Januvia) Prevents the Development of DiabetesCystic Fibrosis;PrediabetesDrug: SitagliptinEmory UniversityNot recruiting13 YearsN/AAll30Phase 3United States;Canada
529NCT01092572May 201019 February 2015Statins To Treat Adult Cystic FibrosisThe Effect of Simvastatin on Systemic Inflammation in Adult Cystic Fibrosis Subjects: A Pilot StudyCystic Fibrosis;Systemic InflammationDrug: Simvastatin;Drug: placeboUniversity of British ColumbiaNot recruiting18 YearsN/ABoth0Phase 1/Phase 2Canada
530NCT01158937May 20101 June 2015Pharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis PatientsPharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis Patient With Exacerbation of Pulmonary InfectionCystic Fibrosis Pulmonary ExacerbationDrug: Meropenem InfusionSt. Michael's Hospital, TorontoSunnybrook Health Sciences Centre;University of TorontoNot recruiting18 YearsN/ABoth2N/ACanada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
531NCT02690857May 20103 June 2019Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF)Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic FibrosisCystic FibrosisDrug: Docosahexaenoic acid;Drug: Sunflower OilHospices Civils de LyonNot recruiting6 Years30 YearsMale10Phase 2
532NCT00763477April 201019 February 2015Ghrelin in Cystic FibrosisThe Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic FibrosisCystic FibrosisBiological: ghrelinPapworth HospitalRecruiting18 Years80 YearsBoth20N/AUnited Kingdom
533NCT01093521April 201011 February 2019A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis PatientsA Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis PatientsCystic FibrosisDrug: 100 mg/m2 dose;Drug: 200 mg/m2 doseUniversity of WashingtonCystic Fibrosis FoundationNot recruiting18 Years55 YearsAll20Phase 1United States
534NCT01321905April 201019 February 2015Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis5-month Pilot Intervention Study on Vitamin D in Patients With Cystic FibrosisCystic FibrosisDietary Supplement: Supplementation with vitamin D2/D3Karolinska InstitutetStockholm County Council, Sweden;Swedish Cystic Fibrosis AssociationRecruiting6 YearsN/ABoth15Phase 2Sweden
535NCT01460836April 201019 February 2015Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisIndirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisCystic FibrosisDrug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalationNovartis PharmaceuticalsNot recruiting6 YearsN/ABothN/A
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
536NCT01086839March 201019 February 2015Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic RhinosinusitisSino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical TrialCystic Fibrosis;RhinosinusitisDrug: sodium chloride 6%;Drug: sodium chloride 0,9%University of JenaNot recruiting8 YearsN/ABoth69N/AGermany
537NCT01348204March 201019 February 2015Nasal Potential Studies Utilizing Cystic Fibrosis Transmembrane Regulator (CFTR) ModulatorsNasal Potential Studies Utilizing CFTR Modulators (UAB Center for Clinical and Translational Science)Cystic FibrosisOther: quercetinUniversity of Alabama at BirminghamNational Institutes of Health (NIH)Not recruiting8 Years65 YearsBoth32Phase 2United States
538NCT02198079March 20101 June 2015A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in FloridaA Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in FloridaCystic Fibrosis;PediatricsBiological: SputumUniversity of MiamiUniversity of FloridaNot recruitingN/A18 YearsBoth85N/AUnited States
539EUCTR2009-014412-35-GB23/02/201019 March 2012An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/AAn International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/ANon-cystic fibrosis bronchiectasis
MedDRA version: 12.0 Level: LLT Classification code 10006446 Term: Bronchiectasis NOS
Product Name: Ciprofloxacin for Inhalation
Product Code: None assigned
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
CAS Number: 86483-48-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Aradigm CorporationAuthorisedFemale: yes
Male: yes
96Germany;United Kingdom
540NCT00889967February 201016 December 2017Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis ORBIT-1An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis BronchiectasisNon-Cystic Fibrosis BronchiectasisDrug: Ciprofloxacin for Inhalation;Drug: PlaceboAradigm CorporationNot recruiting18 Years80 YearsAll95Phase 2United States;Canada;Germany;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
541NCT01051999February 201019 February 2015Glutamine Supplementation in Cystic FibrosisGlutamine Supplementation and Immunity in Adults With Cystic FibrosisCystic Fibrosis;Immune FunctionDietary Supplement: Glutamine;Dietary Supplement: L-alanineEmory UniversityEmmaus Medical, Inc.Not recruiting18 YearsN/ABoth17Phase 2United States
542NCT01059565February 201019 October 2017Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species InfectionPhase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects With Cystic Fibrosis (CF) and Chronic Burkholderia Species InfectionCystic Fibrosis;Burkholderia InfectionsDrug: AZLI;Drug: PlaceboGilead SciencesNot recruiting6 YearsN/AAll102Phase 3United States;Canada
543NCT01060566February 201019 February 2015Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770An Open-Label Phase 1 Study to Examine the Effect of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770 in Healthy SubjectsCystic FibrosisDrug: VX-770Vertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsBoth24Phase 1United States
544NCT01069705February 201016 December 2017Second Open Label Extension to Bridging Study CTBM100C2303A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Completed Participation in Study CTBM100C2303E1.Pulmonary Infections;Pseudomonas AeruginosaDrug: Tobramycin inhalation powderNovartis PharmaceuticalsNot recruiting6 Years21 YearsAll49Phase 3Bulgaria;Estonia;Latvia;Lithuania;Romania;Russian Federation;South Africa
545NCT01288170February 201019 February 2015Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®Cystic FibrosisDrug: Nebcinal Tobi;Drug: Tobi NebcinalErempharmaHopitaux de Lyon;University of LyonRecruiting6 YearsN/ABoth12N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
546EUCTR2009-013340-36-IT25/01/201027 January 2014PREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - NDPREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - NDcystic fibrosis
MedDRA version: 12.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Product Name: reparixin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Reparixin
CAS Number: 266359-83-5
Current Sponsor code: DF 1681Y
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 33-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
IST. DI RICERCHE FARMACOLOG. M. NEGRINot RecruitingFemale: yes
Male: yes
Italy
547EUCTR2009-016734-26-EE08/01/201029 October 2012A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0 Level: LLT Classification code 10021860 Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tobramycin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
548NCT00996424January 201019 February 2015The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung FunctionThe Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function.Cystic FibrosisDrug: Acetylcysteine;Drug: normal salineUniversity Hospital, GhentBVSMNot recruiting6 Years64 YearsBoth19Phase 4Belgium
549NCT01044719January 201019 February 2015Duration of Antibiotics in Infective Exacerbations of Cystic FibrosisWhat Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas AeruginosaCystic FibrosisDrug: Ceftazidime;Drug: Tobramycin;Drug: MeropenemImperial College LondonNot recruiting16 YearsN/ABoth240Phase 4United Kingdom
550NCT01155115January 20101 June 2015Inflammatory and Microbiologic Markers in Sputum: Comparing Cystic Fibrosis With Primary Ciliary DyskinesiaInflammatory and Microbiologic Markers in Sputum in Response to Pulmonary Exacerbation: Comparing Cystic Fibrosis With Primary Ciliary DyskinesiaCystic Fibrosis;Primary Ciliary DyskinesiaProcedure: Sputum Collection;Procedure: Pulmonary Function Testing;Procedure: Exhaled Nitric OxideThe Hospital for Sick ChildrenNot recruiting6 Years18 YearsBoth46N/ACanada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
551EUCTR2010-019267-11-DE29 May 2012AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI)AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI)Correction of steathorrea associated with chronic exocrine pancreatic insufficiency in cystic fibrosis
MedDRA version: 13.1 Level: PT Classification code 10033628 Term: Pancreatic insufficiency System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1 Level: LLT Classification code 10041968 Term: Steatorrhea System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: PANZYTRAT 25000
Product Name: PANZYTRAT 25000
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pancreas Powder
CAS Number: 8049-47-6
Other descriptive name: PANCREATIN
Concentration unit: Other
Concentration type: equal
Concentration number: 25000-
Trade Name: KREON 25000
Product Name: KREON 25000
Pharmaceutical Form: Capsule, hard
CAS Number: 8049-47-6
Other descriptive name: PANCREATIN
Concentration unit: Other
Concentration type: equal
Concentration number: 25000-
Axcan Pharma Inc.Not RecruitingFemale: yes
Male: yes
68Germany
552EUCTR2010-023235-41-PL2 October 2017A comparative, randomised, two period, multi-center, cross-over 14 weeks bioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) in cystic fibrosis patients with bronchopulmonary chronic Pseudomonas aeruginosa infection - T-100 BEA comparative, randomised, two period, multi-center, cross-over 14 weeks bioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) in cystic fibrosis patients with bronchopulmonary chronic Pseudomonas aeruginosa infection - T-100 BECystic fibrosis with bronchopulmonary chronic Pseudomonas aeruginosa infection
MedDRA version: 12.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Product Name: Tobramycin
Product Code: T100
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Other descriptive name: Tobramycinum
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 170/1,7-
Trade Name: TOBI®
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: TOBRAMYCIN
CAS Number: 32986-56-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 300/5,0-
PARI Pharma GmbHNot RecruitingFemale: yes
Male: yes
60Phase 1Poland
553EUCTR2010-023533-34-FR2 October 2017Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® /Pulmoaid ® chez des patients atteints de mucoviscidose.Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® /Pulmoaid ® chez des patients atteints de mucoviscidose.Mucoviscidose
MedDRA version: 12.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Product Name: Nebcinal
Product Code: Nebcinal
Pharmaceutical Form: Inhalation vapour, solution
Trade Name: Tobi
Product Name: Tobi
Pharmaceutical Form: Inhalation vapour, solution
EREMPHARMA SASNot AvailableFemale: yes
Male: yes
Phase 1France
554EUCTR2009-016590-15-HU29/12/20094 August 2015A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years includedA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1 Level: LLT Classification code 10068292 Term: Pseudomonas colonization System Organ Class: 100000004862
MedDRA version: 14.1 Level: LLT Classification code 10068297 Term: Pseudomonas colonisation System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI 300 mg / 5 mL nebuliser solution
Product Name: TOBI
Product Code: TBM100
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Current Sponsor code: TBM100
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
50France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Italy;Switzerland
555NCT00812045December 200919 February 2015Study to Assess Efficacy of AZD1236 in Patients With Cystic FibrosisA Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II Study to Assess the Efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients With Cystic FibrosisCystic FibrosisDrug: AZD1236;Drug: PlaceboAstraZenecaNot recruiting18 YearsN/ABoth44Phase 2Canada;Netherlands;Poland;Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
556NCT01025713December 20093 August 2015A Phase 1 Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS 9411 in Subjects With Cystic Fibrosis (CF)A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS 9411 in Subjects With Cystic Fibrosis (CF)Cystic Fibrosis;Mucociliary ClearanceDrug: GS-9411;Drug: PlaceboGilead SciencesNot recruiting18 Years65 YearsBoth0Phase 1Australia
557NCT01035853December 200919 February 2015Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa ColonizationSino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas AeruginosaCystic Fibrosis;Pseudomonas AeruginosaDrug: ColistinUniversity of JenaNot recruiting6 YearsN/ABoth10Phase 2Germany
558NCT01658449December 200919 February 2015Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis PatientsCystic FibrosisOther: Inhalable Hypertonic saline 7% + Hyaluronan 0.1%;Other: Inhalable Hypertonic saline 7%Ospedale Civile Ca' FoncelloNot recruiting8 YearsN/ABoth40N/AItaly
559EUCTR2008-008317-20-BE13/11/20097 October 2014The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung functionThe effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung functionCystic Fibrosis
MedDRA version: 12.0 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Trade Name: Lysomucil 10 %
Product Name: N-acetylcysteine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Acetylcysteine
CAS Number: 616-91-1
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Inhalation use
University Hospital GhentNot RecruitingFemale: yes
Male: yes
Belgium
560EUCTR2009-016662-90-FR03/11/200919 March 2012Etude de cohorte évaluant l'efficacité cliique, la tolérance et l'immunogénicité à la vaccination antigrippale pandémique chez les patients atteints de mucoviscidose et, le cas échéant, l'expression clinique de la grippe A (H1N1) et les facteurs associés à la survenue de formes sévères dans cette population. - Etude MUCOFLUEtude de cohorte évaluant l'efficacité cliique, la tolérance et l'immunogénicité à la vaccination antigrippale pandémique chez les patients atteints de mucoviscidose et, le cas échéant, l'expression clinique de la grippe A (H1N1) et les facteurs associés à la survenue de formes sévères dans cette population. - Etude MUCOFLUpatients atteints de mucoviscidose
MedDRA version: 12.0 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Trade Name: Oseltamivir
Pharmaceutical Form: Capsule*
Product Name: Vaccin grippal pandémique H1N1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Vaccin grippal pandémique H1N1
InsermAuthorisedFemale: yes
Male: yes
France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
561NCT01018368November 200919 February 2015Study of VX-770 and Rifampin in Healthy Male SubjectsAn Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy SubjectsCystic FibrosisDrug: VX-770;Drug: RifampinVertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsMale24Phase 1United States
562NCT01094704November 200919 October 2017Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic FibrosisDurability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic FibrosisCystic FibrosisDrug: sodium chloride (7%)University of North Carolina, Chapel HillJohns Hopkins University;Novartis PharmaceuticalsNot recruiting18 YearsN/AAll16Phase 1United States
563EUCTR2009-014042-28-GB16/10/200919 March 2012What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosisWhat duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosisCystic FibrosisTrade Name: Meropenem
Product Name: Meropenem
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Meropenem
CAS Number: 119478-56-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 50-
Trade Name: Ceftazidime
Product Name: Ceftazidime
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Ceftazidime
CAS Number: 72558-82-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 200-
Trade Name: Tobramycin
Product Name: Tobramycin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 40-
Imperial College, LondonAuthorisedFemale: yes
Male: yes
240United Kingdom
564EUCTR2009-015875-28-IT07/10/20093 April 2012Modulation of intestinal and extraintestinal inflammation in infants with Cystic Fibrosis by early modification of intestinal microflora - Role of intestinal microflora in infants with Cystic FibrosisModulation of intestinal and extraintestinal inflammation in infants with Cystic Fibrosis by early modification of intestinal microflora - Role of intestinal microflora in infants with Cystic Fibrosisinfants with cystic fibrosis
MedDRA version: 9.1 Level: SOC Classification code 10017947
MedDRA version: 9.1 Level: SOC Classification code 10038738
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lactic acid producing organisms
Concentration unit: CFU/g colony forming unit(s)/gram
Concentration type: equal
Concentration number: 20000000000-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO IIAuthorisedFemale: yes
Male: yes
Italy
565NCT00999531October 200919 February 2015A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy VolunteersA Phase 1, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy VolunteersCystic Fibrosis;Mucociliary Clearance;Airway HydrationDrug: GS-9411;Drug: PlaceboGilead SciencesNot recruiting18 Years65 YearsBoth24Phase 1Australia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
566NCT00903201September 28, 200916 December 201728 Day Repeat Dose in Cystic Fibrosis PatientsA Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients With Cystic Fibrosis.Cystic FibrosisDrug: SB656933;Drug: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/AAll146Phase 2United States;Canada;France;Germany;Israel
567EUCTR2009-014050-15-BE18/09/200914 October 2013Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XLConversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XLStable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant
MedDRA version: 12.0 Level: LLT Classification code 10025127 Term: Lung transplant
Trade Name: Prograft capsules
Product Name: Tacrolimus capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 104987113
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
INN or Proposed INN: TACROLIMUS
CAS Number: 104987113
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: TACROLIMUS
CAS Number: 104987113
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Advagraf prolonged-release hard capsules
Product Name: Tacrolimus prolonged-release hard capsules
Pharmaceutical Form: Capsule, hard
Hopital Erasme - Chest serviceAuthorisedFemale: yes
Male: yes
Belgium
568EUCTR2009-013660-39-FR10/09/200919 March 2012Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ®Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ®Mucoviscidose
MedDRA version: 12.0 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Product Name: Nebcinal
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: tobramycine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: Tobi
Product Name: Tobi
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: tobramycine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Erempharma SASAuthorisedFemale: yes
Male: yes
France
569EUCTR2008-002318-22-LT07/09/200929 May 2012A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1 Level: LLT Classification code 10021860 Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: tobramycin
Other descriptive name: TBM100C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
570EUCTR2008-004764-39-LT07/09/200915 May 2012A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 13.1 Level: LLT Classification code 10021860 Term: Infection pseudomonas aeruginosa System Organ Class: 10021881 - Infections and infestations
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: tobramycin
Current Sponsor code: TBM100C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
571NCT00951522September 200919 February 2015A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male VolunteersA Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male VolunteersCystic Fibrosis;Mucociliary Clearance;Airway HydrationDrug: GS-9411;Drug: PlaceboGilead SciencesNot recruiting18 Years45 YearsMale15Phase 1Australia
572NCT00953706September 200919 October 2017Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsNot recruiting12 YearsN/AAll140Phase 2United States
573NCT00966602September 200919 February 2015Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy SubjectsA Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy SubjectsCystic FibrosisDrug: VX-809;Drug: VX-770;Drug: VX-809 & VX-770;Drug: PlaceboVertex Pharmaceuticals IncorporatedNot recruiting18 Years55 YearsBoth24Phase 1Netherlands
574NCT00970346September 200911 April 2016Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic FibrosisA Randomised, Double-blind, Placebo-controlled Dose-escalation Phase I Study to Evaluate the Safety and Tolerability of Inhaled Aerosolised OligoG CF-5/20 (G-block Oligosaccharide Derived From Alginate Polysaccharide) in Healthy VolunteersCystic FibrosisDrug: OligoG CF-5/20AlgiPharma ASSmerud Medical Research International ASNot recruiting18 Years65 YearsMale26Phase 1United Kingdom
575NCT00975663September 200919 February 2015Bayesian Dose Adjustment of Immunosuppressants After Lung TransplantationEvaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic FibrosisLung and Heart-lung TransplantationDrug: Tacrolimus and MMFUniversity Hospital, LimogesNot recruiting18 YearsN/ABoth180Phase 4Belgium;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
576NCT00989807September 200919 February 2015Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic FibrosisExpanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease ProgressionCystic Fibrosis;Pseudomonas AeruginosaDrug: Aztreonam lysineGilead SciencesNot recruiting6 YearsN/ABothN/ACanada
577NCT01031706September 200916 December 2017Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic FibrosisSustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic FibrosisCystic FibrosisDrug: Hypertonic Saline;Drug: PlaceboUniversity of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting5 Years12 YearsAll23N/AUnited States
578NCT01111383September 200911 June 2018A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa)Cystic FibrosisDrug: tobramycinChiesi Farmaceutici S.p.A.Not recruiting6 YearsN/AAll209Phase 3France;Poland;Ukraine
579NCT01710449September 200919 February 2015Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With OxygenEvaluation of Regional Ventilation in Normal Subjects and Subjects With Airway and Lung Disorders (COPD, Asthma, Emphysema, Small Airway Disease and Cystic Fibrosis) Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen.COPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways DiseasesDrug: perfluorinated gas/oxygen mixtureHal C CharlesNot recruiting18 YearsN/ABoth44Phase 1United States
580NCT01961661September 200919 February 2015Probiotics on Intestinal Inflammation in Cystic FibrosisEffect of Probiotics on Intestinal Inflammation and Microflora in Cystic Fibrosis: a Pilot StudyCystic FibrosisDietary Supplement: Lactobacillus rhamnosus GG;Dietary Supplement: placeboFederico II UniversityNot recruiting2 Years18 YearsBoth22Phase 3Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
581EUCTR2008-006446-25-NL26/08/200919 March 2012A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101Cystic Fibrosis
MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
MedDRA version: 9.1 Level: LLT Classification code 10011764 Term: Cystic fibrosis NOS
Product Name: VX-809
Product Code: VX-809
Pharmaceutical Form: Capsule, hard
CAS Number: 936727-05-8
Current Sponsor code: VX-809
Other descriptive name: VRT-826809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-50
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
90Germany;Netherlands;Belgium
582EUCTR2008-007416-15-IE11/08/200910 July 2015Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVECystic Fibrosis
MedDRA version: 14.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Other descriptive name: VRT-813077
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
583EUCTR2008-007479-26-IE11/08/200929 May 2012Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D MutationA Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISIONCystic Fibrosis
MedDRA version: 14.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ivacaftor
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Other descriptive name: VRT-813077
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Vertex Pharmaceuticals IncorporatedNot RecruitingFemale: yes
Male: yes
40Phase 3Germany;United Kingdom;Canada;France;Ireland;United States;Australia
584NCT00803205July 200916 December 2017Study of Ataluren (PTC124™) in Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: Ataluren (PTC124);Drug: PlaceboPTC TherapeuticsCystic Fibrosis Foundation TherapeuticsNot recruiting6 YearsN/AAll238Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom
585NCT00910351July 200919 February 2015Cipro Inhaler for Cystic Fibrosis Children Ages 6-12A Study to Evaluate the Safety and Pharmacokinetics of Ciprofloxacin in Adults and Children Aged 6 - 12 Years With Cystic Fibrosis Following Inhalation of Ciprofloxacin Dry PowderPseudomonas InfectionDrug: Ciprofloxacin (Cipro, BAYQ3939)BayerNot recruiting6 Years12 YearsBoth19Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
586NCT00945347July 200919 February 2015Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients ?Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind Placebo-controlled Study.Cystic FibrosisDrug: Miglustat;Drug: PlaceboCliniques universitaires Saint-Luc- Université Catholique de LouvainNot recruiting14 YearsN/ABoth10Phase 2Belgium
587EUCTR2008-007877-19-DE15/06/200929 April 2013Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich. Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilotNasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich. Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilotsubjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Trade Name: Colistin CF
Product Name: Colistin CF
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Colistimethat-Natrium
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1 million-
University of JenaNot RecruitingFemale: yes
Male: yes
14Germany
588EUCTR2009-009869-34-DE08/06/200911 March 2013Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted)
MedDRA version: 9.1 Level: LLT Classification code 10006445 Term: Bronchiectasis
MedDRA version: 9.1 Level: PT Classification code 10006445 Term: Bronchiectasis
Product Name: Cipro Inhale
Product Code: BAYq3939
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Ciprofloxacin
CAS Number: 85721-33-1
Current Sponsor code: BAYQ3939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 32,5-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use
Bayer HealthCare AGNot RecruitingFemale: yes
Male: yes
122Spain;Germany;United Kingdom;Sweden
589ChiCTR-TRC-130039792009-05-0718 April 2017Application of roxithromycin in patients with bronchiectasis in stable conditionEffect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasisBronchietasisRoxithromycin group:The patients received oral roxithromycin in roxithromycin group;Control group:The patients received no drug in control group;First Affiliated Hospital of Guangxi Medical UniversityNot Recruiting1870BothRoxithromycin group:26;Control group:26;Post-marketChina
590NCT01737983May 200919 February 2015Effect of Lactobacillus Reuteri in Cystic FibrosisLactobacillus Reuteri Reduces Pulmonary Exacerbations and Upper Respiratory Tract Infections in CF Patients With Mild-to-moderate Lung Disease. LR Administration Might Have a Beneficial Effect on the Disease Course of Cystic Fibrosis.CYSTIC FIBROSISDietary Supplement: Lactobacillus reuteri;Dietary Supplement: placeboAzienda Policlinico Umberto INot recruiting6 Years42 YearsBoth61Phase 4Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
591NCT01880723May 200919 October 2017Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic FibrosisModifying Genes in Cystic Fibrosis: The Beta-2 Adrenergic Receptors and Epithelial Na+ ChannelsCystic Fibrosis;HealthyDrug: Albuterol;Drug: Placebo salineUniversity of ArizonaNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting15 Years55 YearsAll32N/AUnited States
592EUCTR2009-011289-27-IT22/04/20093 April 2012Probiotics in Cystic Fibrosis - NDProbiotics in Cystic Fibrosis - NDCystic Fibrosis Patients
MedDRA version: 9.1 Level: SOC Classification code 10017947
Pharmaceutical Form: Modified-release capsule, soft
INN or Proposed INN: Lactic acid producing organisms
Concentration unit: CFU/g colony forming unit(s)/gram
Concentration type: equal
Concentration number: 20000000000-
Pharmaceutical form of the placebo: Modified-release capsule, soft
Route of administration of the placebo: Oral use
UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO IIAuthorisedFemale: yes
Male: yes
Italy
593EUCTR2008-003924-52-SE08/04/200919 November 2012A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisNonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: ataluren
CAS Number: 775304-57-9
Current Sponsor code: PTC124
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Powder for oral suspension
Route of administration of the placebo: Oral use
Product Name: PTC124
Product Code: PTC124
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: ataluren
CAS Number: 775304-57-9
Current Sponsor code: PTC124
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Powder for oral suspension
Route of administration of the placebo: Oral use
Product Name: PTC124
Product Code: PTC124
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: ataluren
CAS Number: 775304-57-9
Current Sponsor code: PTC124
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Powder for oral suspension
Route of administration of the placebo: Oral use
PTC Therapeutics, IncNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
594NCT00709280April 200919 February 2015Infant Study of Inhaled Saline in Cystic FibrosisInfant Study of Inhaled Saline in Cystic FibrosisCystic FibrosisDrug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS)CF Therapeutics Development Network Coordinating CenterCystic Fibrosis Foundation Therapeutics;National Heart, Lung, and Blood Institute (NHLBI)Not recruiting4 Months59 MonthsBoth321N/AUnited States;Canada
595NCT00775528April 200919 October 2017Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisAn Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisCystic Fibrosis;Pancreatic Exocrine InsufficiencyDrug: Pancrelipase Delayed ReleaseSolvay PharmaceuticalsNot recruiting1 Month6 YearsAll19Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
596NCT00840333April 200929 January 2018Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) PatientsA Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Given Daily for 14 Days to Stable Pediatric Cystic Fibrosis Patients.Cystic FibrosisDrug: MP-376 (Levofloxacin solution for Inhalation)Horizon Pharma USA, Inc.Not recruiting6 Years16 YearsAll27Phase 1United States
597NCT00843817April 200916 December 2017RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis SputumRhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis SputumCystic FibrosisDrug: PulmozymeUniversity Hospital, ToursNot recruiting18 YearsN/AAll15Phase 4France
598NCT00880100April 200916 December 2017Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)Efficacy and Safety of Ultrase MT12 in the Control of Steatorrhea in Cystic Fibrosis (CF) and Pancreatic Insufficient (PI) Children Aged 2 to 6 Years OldCystic Fibrosis;Pancreatic InsufficiencyDrug: Ultrase® MT12Forest LaboratoriesNot recruiting2 Years6 YearsAll49Phase 3United States
599NCT00885365April 200919 October 2017A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas AeruginosaCystic FibrosisDrug: tobramycin / Bramitob;Drug: tobramycin / TOBIChiesi Farmaceutici S.p.A.Not recruiting6 YearsN/AAll324Phase 3Czech Republic;France;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine
600EUCTR2008-001530-27-GB11/03/200919 March 2012A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic FibrosisA Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic FibrosisCystic Fibrosis
MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Product Name: AZD9668
Product Code: AZD9668
Pharmaceutical Form: Tablet
INN or Proposed INN: none
CAS Number: none
Current Sponsor code: AZD9668
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
AstraZeneca ABNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom;Denmark;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
601EUCTR2009-009875-37-NL11/03/200910 June 2013A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRDA placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRDCystic fibrosis-related diabetes
MedDRA version: 9.1 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes)
MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Trade Name: Metformine HCL 500 PCH
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Staf LongziektenNot RecruitingFemale: yes
Male: yes
25Netherlands
602NCT00865904March 200919 October 2017Study of VX-809 in Cystic Fibrosis Subjects With the ?F508-CFTR Gene MutationA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of VX-809 to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of VX-809 in Cystic Fibrosis Subjects Homozygous for the ?F508-CFTR Gene MutationCystic FibrosisDrug: VX-809;Drug: PlaceboVertex Pharmaceuticals IncorporatedNot recruiting18 YearsN/AAll93Phase 2United States;Belgium;Canada;Germany;Netherlands
603NCT01377792March 200919 February 2015Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic FibrosisPhase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic FibrosisCystic FibrosisDrug: Hypertonic salineAdelaida Lamas FerreiroNot recruiting6 YearsN/ABoth71Phase 4Spain
604EUCTR2008-005080-33-IT05/02/20093 April 2012RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSISRANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSISCystic fibrosis.
MedDRA version: 9.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Trade Name: TAD 600
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: Glutathione
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Powder for nebuliser solution
Route of administration of the placebo: Inhalation use
AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLIAuthorisedFemale: yes
Male: yes
Italy
605NCT00663975February 200919 February 2015Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) PatientsAn Open-Label, Multi-Center Safety and Efficacy Study of DCI-1020 in Pediatric Cystic Fibrosis Patients With Exocrine Pancreatic InsufficiencyDigestive System Diseases;Pancreatic Disease;Cystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: DCI 1020Digestive Care, Inc.Not recruitingN/A2 YearsBoth24N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
606NCT00846781February 200919 February 2015Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)Cystic FibrosisDrug: Denufosol tetrasodium Inhalation SolutionMerck Sharp & Dohme Corp.Not recruiting5 YearsN/ABoth308Phase 3United States;Australia;Canada;New Zealand
607EUCTR2008-008228-34-GB28/01/200919 March 2012Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patientsDetermination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patientsCystic Fibrosis
MedDRA version: 8.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Product Name: IDPM: Inhaled Dry Powder Mannitol
Product Code: IDPM
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: MANNITOL
CAS Number: 69658
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaxis LtdNot RecruitingFemale: yes
Male: yes
18United Kingdom
608EUCTR2008-001284-11-ES19/01/200919 March 2012Estudio de la eficacia del tratamiento a largo plazo con suero salino hipertónico sobre las exacerbaciones pulmonares en pacientes con Fibrosis QuísticaEstudio de la eficacia del tratamiento a largo plazo con suero salino hipertónico sobre las exacerbaciones pulmonares en pacientes con Fibrosis QuísticaFibrosis Quística
MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Trade Name: CLORURO SODICO 7%
Product Name: CLORURO SODICO 7%
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: CLORURO SODICO 7%
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-12H
Trade Name: CLORURO SODICO 7%
Product Name: CLORURO SODICO 7%
Pharmaceutical Form:
INN or Proposed INN: CLORURO SODICO 7%
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 5-12H
ADELAIDA LAMAS FERREIROAuthorisedFemale: yes
Male: yes
Spain
609NCT03905642January 8, 200915 April 2019Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) - Extension PhaseMultidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE TM) in Cystic Fibrosis Patients With Chronic Infections Due to Pseudomonas AeruginosaCystic FibrosisDrug: ArikaceInsmed IncorporatedNot recruiting6 YearsN/AAll49Phase 2Belgium;Hungary;Macedonia, The Former Yugoslav Republic of;Poland;Serbia;Slovakia;Ukraine
610EUCTR2009-011740-19-Outside-EU/EEA16 February 2015Clinical Trial to Assess the Safety and Efficacy of Aztreonam for Inhalation Solution (AZLI) in patients with Cystic Fibrosis (CF) and Chronic Burkholderia Species InfectionPhase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects with Cystic Fibrosis (CF) and Chronic Burkholderia Species InfectionCystic Fibrosis subjects with chronic Burkholderia spp. infection of the airways.
MedDRA version: 17.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
INN or Proposed INN: AZTREONAM
CAS Number: 78110-38-0
Current Sponsor code: AZLI
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Powder and solvent for nebuliser solution
Route of administration of the placebo: Inhalation use
Gilead Sciences, Inc.Not AvailableFemale: yes
Male: yes
100Phase 3bUnited States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
611EUCTR2008-005045-34-GB15/12/20089 May 2016A clinical study to investigate the effect and safety of up to 6 months of treatment with inhaled Promixin in the treatment of chest infections causeed by Pseudomonas in people with a lung disease called bronchiectasisA double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasisnon-CF bronchiectasis (CF = cystic fibrosis)
MedDRA version: 14.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution
Pharmaceutical Form: Powder for nebuliser solution
Other descriptive name: colistimethate sodium
Concentration unit: Munit million units
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Profile Pharma LtdNot RecruitingFemale: yes
Male: yes
144Phase 3Ukraine;Ireland;Russian Federation;United Kingdom
612NCT00685971December 200819 February 2015Cholecalciferol for Vitamin D in Adult Cystic Fibrosis (CF) PatientsRandomized Placebo-Controlled Trial of Cholecalciferol for Vitamin D Deficiency in Adults With Cystic FibrosisCystic Fibrosis;Vitamin D DeficiencyDietary Supplement: 5000 IU of cholecalciferol;Dietary Supplement: placeboSt. Michael's Hospital, TorontoNot recruiting18 YearsN/ABoth200N/ACanada
613NCT00792714December 200819 February 2015Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis PatientsDetermination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis PatientsCystic FibrosisDrug: MannitolPharmaxisNot recruiting6 YearsN/ABoth18Phase 1Australia;United Kingdom
614EUCTR2008-002740-42-DE13/11/20083 September 2012Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyCystic Fibrosis
MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Mannitol
CAS Number: 69658
Concentration unit: mg milligram(s)
Concentration number: 40-
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Mannitol
CAS Number: 69658
Concentration unit: mg milligram(s)
Concentration number: 5-
Product Name: Inhaled dry powder mannitol
Product Code: MTT
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Mannitol
CAS Number: 69658
Concentration unit: mg milligram(s)
Concentration number: 40-
Pharmaxis Pharmaceuticals LimitedNot RecruitingFemale: yes
Male: yes
300Germany;Netherlands;Belgium;France
615EUCTR2007-006648-23-DE12/11/200819 March 2012An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisPatients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
MedDRA version: 9.1 Level: LLT Classification code 10000244 Term: ABPA
Trade Name: Xolair 150 mg Pulver und Injektionslösung zur Herstellung einer Injektionslösung
Product Name: Xolair
Product Code: IGE025
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Omalizumab
CAS Number: 242138-07-4
Current Sponsor code: IGE025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
60United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
616NCT00787917November 200819 October 2017An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)Cystic Fibrosis;Allergic Bronchopulmonary AspergillosisDrug: Omalizumab;Drug: Placebo;Drug: ItraconazoleNovartis PharmaceuticalsNot recruiting12 YearsN/AAll14Phase 4Belgium;Germany;Italy;Netherlands;United Kingdom
617NCT00789867November 200829 June 2015Single Dose of pGM169/GL67A in CF PatientsEvaluation of Safety and Gene Expression With a Single Dose of pGM169/GL67A Administered to the Nose and Lung of Individuals With Cystic FibrosisCystic FibrosisDrug: pGM169/GL67AImperial College LondonRoyal Brompton & Harefield NHS Foundation Trust;University of Oxford;University of Edinburgh;Cystic Fibrosis Trust;University of PennsylvaniaNot recruiting16 Years70 YearsBoth27Phase 1/Phase 2United Kingdom
618NCT00794586November 200819 February 2015Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung InfectionA Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients With Cystic Fibrosis and Pseudomonas AeruginosaCystic FibrosisDrug: FTI, AZLI;Drug: Placebo, AZLIGilead SciencesNot recruiting18 YearsN/ABoth120Phase 2United States
619NCT00800579November 200819 February 2015Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male VolunteersA Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male VolunteersCystic FibrosisDrug: GS-9411;Drug: PlaceboGilead SciencesNot recruiting18 Years45 YearsMale12Phase 1Australia
620NCT00803179November 200819 October 2017Growth Hormone Therapy for Wasting in Cystic FibrosisGrowth Hormone Therapy for Wasting in Cystic FibrosisCystic FibrosisDrug: Nutropin AQUniversity of Massachusetts, WorcesterNot recruiting18 YearsN/AAll5Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
621NCT00809094November 200819 October 2017NAC Phase IIB: A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis PatientsA Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis PatientsCystic FibrosisDrug: N-acetylcysteine (NAC);Drug: PlaceboStanford UniversityCystic Fibrosis Foundation TherapeuticsNot recruiting7 YearsN/AAll70Phase 2United States
622NCT00846573November 200819 October 2017Hyperpolarized Noble Gas MR Imaging for Pulmonary DisordersHyperpolarized Noble Gas MR Imaging for Pulmonary DisordersCOPD;Cystic Fibrosis;Asthma;HealthyDrug: Hyperpolarized Helium-3University of Massachusetts, WorcesterNot recruiting5 YearsN/AAll14N/AUnited States
623NCT01112059November 200816 December 2017Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) PatientsA Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary ExacerbationsCystic FibrosisDrug: Doxycycline;Other: placeboUniversity of Alabama at BirminghamCystic Fibrosis Foundation TherapeuticsNot recruiting19 YearsN/AAll40N/AUnited States
624EUCTR2008-004699-34-NL28/10/200826 June 2012A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis. - CYBERA Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis. - CYBERCystic Fibrosis
MedDRA version: 9.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Product Code: AZD1236
Pharmaceutical Form: Tablet
Current Sponsor code: AZD1236
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Rout