299. 嚢胞性線維症
［臨床試験数：1,592，薬物数：1,539（DrugBank：255），標的遺伝子数：81，標的パスウェイ数：162］
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03435939 (ClinicalTrials.gov) | February 1, 2021 | 5/2/2018 | Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240 | Anti-Inflammatory Therapy to Augment CFTR Rescue in CF Patients | Cystic Fibrosis | Drug: Losartan | University of Kansas Medical Center | NULL | Not yet recruiting | 18 Years | N/A | All | 16 | Early Phase 1 | United States |
| 2 | NCT03931252 (ClinicalTrials.gov) | February 2021 | 25/4/2019 | Thermic Effect of Feeding in Cystic Fibrosis | Thermic Effect of Feeding in Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Boost VHC;Dietary Supplement: Ensure High Protein | Virginia Commonwealth University | NULL | Enrolling by invitation | 18 Years | N/A | All | 10 | N/A | United States |
| 3 | NCT04656275 (ClinicalTrials.gov) | January 25, 2021 | 1/12/2020 | A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Oral Doses of BI 1323495 Bid Versus Placebo in Patients With Non-cystic Fibrosis Bronchiectasis (Randomised, Double-blind, Placebo-controlled, Parallel Group Trial) | Non-cystic Fibrosis Bronchiectasis | Drug: BI 1323495;Drug: Placebo | Boehringer Ingelheim | NULL | Not yet recruiting | 18 Years | 80 Years | All | 36 | Phase 1 | NULL |
| 4 | NCT04580368 (ClinicalTrials.gov) | January 4, 2021 | 2/10/2020 | Testing Drug Efficacy in Cystic Fibrosis Through N-of-1 Trials | Testing Drug Efficacy in Cystic Fibrosis Through N-of-1 Trials | Cystic Fibrosis | Drug: CFTR Modulators | Children's Hospital Medical Center, Cincinnati | NULL | Not yet recruiting | 6 Years | N/A | All | 50 | N/A | NULL |
| 5 | NCT04599465 (ClinicalTrials.gov) | January 2021 | 21/10/2020 | A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF) | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose Metabolism | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not yet recruiting | 12 Years | N/A | All | 60 | Phase 3 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT04545515 (ClinicalTrials.gov) | January 2021 | 3/9/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF Genotypes | A Phase 3b Open-Label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not yet recruiting | 6 Years | N/A | All | 108 | Phase 3 | NULL |
| 7 | NCT04315311 (ClinicalTrials.gov) | December 31, 2020 | 18/3/2020 | Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer | A Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer | Exocrine Pancreatic Insufficiency (EPI) | Drug: CREON | AbbVie | NULL | Not yet recruiting | 18 Years | N/A | All | 50 | Phase 4 | United States |
| 8 | NCT04322929 (ClinicalTrials.gov) | December 30, 2020 | 24/3/2020 | Roflumilast in Non-CF Bronchiectasis Study (2019) | Anti-inflammatory Effects of Roflumilast Treatment for 12 Weeks in Stable-state Non-cystic Fibrosis Bronchiectasis | Non-cystic Fibrosis Bronchiectasis | Drug: Roflumilast Oral Tablet | The University of Hong Kong | NULL | Not yet recruiting | 18 Years | N/A | All | 27 | Phase 2 | Hong Kong |
| 9 | EUCTR2019-002840-26-GB (EUCTR) | 22/12/2020 | 03/09/2020 | Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasis | A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis | Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Icenticaftor Other descriptive name: CFTR potentiator | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | Spain;Germany;China;United Kingdom | ||
| 10 | EUCTR2020-003170-44-CZ (EUCTR) | 03/12/2020 | 22/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis | 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: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2016-004558-13-DE (EUCTR) | 01/12/2020 | 09/04/2020 | 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) | 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 II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;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 Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;United States;France;Greece;Canada;Argentina;Poland;Germany | ||
| 12 | NCT03698448 (ClinicalTrials.gov) | December 1, 2020 | 3/10/2018 | A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis | A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: OligoG Dry powder for inhalation | AlgiPharma AS | Imperial College London;Cystic Fibrosis Foundation;European Cystic Fibrosis Society;University Hospital of Cologne;Cystic Fibrosis Europe | Not yet recruiting | 12 Years | N/A | All | 120 | Phase 2;Phase 3 | Germany |
| 13 | NCT04533646 (ClinicalTrials.gov) | December 1, 2020 | 23/8/2020 | Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes | Comparison of Meal-Time Dosing of Rapid Acting Insulin Using Carbohydrate Counting vs. Fixed Doses Utilizing Continuous Glucose Monitoring In Patients With Cystic Fibrosis Related Diabetes | Cystic Fibrosis-related Diabetes | Drug: Insulin;Device: Continuous glucose monitor (CGM) | Jagdeesh Ullal | Wake Forest University Health Sciences | Not yet recruiting | 18 Years | 80 Years | All | 20 | Phase 4 | NULL |
| 14 | NCT04594369 (ClinicalTrials.gov) | December 1, 2020 | 14/10/2020 | A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis | Drug: Brensocatib 10 mg;Drug: Brensocatib 25 mg;Drug: Placebo | Insmed Incorporated | NULL | Recruiting | 18 Years | 85 Years | All | 1620 | Phase 3 | United States |
| 15 | NCT02547116 (ClinicalTrials.gov) | December 2020 | 9/9/2015 | Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic Fibrosis | Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic Fibrosis | Cystic Fibrosis;MRSA | Drug: Rifampin | Johns Hopkins University | NULL | Suspended | 12 Years | N/A | All | 16 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT04596319 (ClinicalTrials.gov) | December 2020 | 15/10/2020 | Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis | A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects With Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (Pa) Infection | Cystic Fibrosis;Pseudomonas Aeruginosa;Pseudomonas;Lung Infection;Lung Infection Pseudomonal | Biological: AP-PA02;Other: Placebo | Armata Pharmaceuticals, Inc. | Cystic Fibrosis Foundation | Recruiting | 18 Years | N/A | All | 48 | Phase 1;Phase 2 | United States |
| 17 | NCT03058068 (ClinicalTrials.gov) | December 2020 | 6/2/2017 | Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis | A 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 - HAPI | Cystic Fibrosis | Biological: Allo-hMSCs;Biological: Placebo | Joshua M Hare | NULL | Withdrawn | 20 Years | 45 Years | All | 0 | Phase 1 | United States |
| 18 | NCT04643587 (ClinicalTrials.gov) | December 2020 | 19/11/2020 | Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB) | A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Nebulized CSL787 in Healthy Subjects and Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) | Noncystic Fibrosis Bronchiectasis (NCFB) | Biological: CSL787;Drug: Placebo | CSL Behring | NULL | Not yet recruiting | 18 Years | N/A | All | 64 | Phase 1 | NULL |
| 19 | NCT03921060 (ClinicalTrials.gov) | December 2020 | 26/3/2019 | Markers of Osteoporosis in Cystic Fibrosis | Markers of Osteoporosis in Cystic Fibrosis | Cystic Fibrosis | Drug: Denosumab | University of Texas Southwestern Medical Center | NULL | Not yet recruiting | 12 Years | 64 Years | All | 100 | Phase 4 | United States |
| 20 | NCT04509050 (ClinicalTrials.gov) | November 18, 2020 | 6/8/2020 | Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children | A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN Study) | Cystic Fibrosis | Drug: Ivacaftor or elexacaftor/tezacaftor/ivacaftor | Sonya Heltshe | Cystic Fibrosis Foundation;University of Washington;University of Alabama at Birmingham | Recruiting | N/A | 5 Years | All | 210 | United States | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT04624490 (ClinicalTrials.gov) | November 2, 2020 | 31/10/2020 | Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease | Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease | Asthma;COPD;Interstitial Lung Disease;Cystic Fibrosis;Pulmonary Hypertension;Pulmonary Infection;Other Lung Disease | Drug: Hyperpolarized Xe129 | Mario Castro, MD, MPH | NULL | Not yet recruiting | 18 Years | N/A | All | 260 | Phase 1 | NULL |
| 22 | NCT04537793 (ClinicalTrials.gov) | November 2020 | 28/8/2020 | Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years | A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not yet recruiting | 2 Years | 5 Years | All | 84 | Phase 3 | NULL |
| 23 | NCT04579939 (ClinicalTrials.gov) | November 2020 | 29/9/2020 | Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis | Oral Glucose Tolerance Testing Using Candy: A Sweet Solution to Improve Screening Compliance in Cystic Fibrosis | Cystic Fibrosis | Diagnostic Test: Candy Glucose Tolerance Test | Mayo Clinic | NULL | Not yet recruiting | 10 Years | 21 Years | All | 10 | N/A | United States |
| 24 | EUCTR2019-003554-86-FR (EUCTR) | 29/10/2020 | 02/04/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland | ||
| 25 | EUCTR2019-004511-31-IT (EUCTR) | 21/10/2020 | 07/10/2020 | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE Product Name: Noxafil Product Code: [NA] INN or Proposed INN: Posaconazolo Trade Name: Noxafil Product Name: Noxafil Product Code: [NA] INN or Proposed INN: POSACONAZOLO Trade Name: Noxafil Product Name: Noxafil Product Code: [NA] INN or Proposed INN: POSACONAZOLO Product Name: Noxafil Product Code: [na] INN or Proposed INN: POSACONAZOLO Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE Product Name: Noxafil Product Code: [na] INN or Proposed INN: POSACONAZOLO Trade Name: Noxafil Product Name: Noxafil Product Code: [na] INN or Proposed INN: Posaconazolo | IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2020-001404-42-GB (EUCTR) | 12/10/2020 | 25/08/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - Phase 3b Open-label Study of ELX/TEZ/IVA in subjects 6 years & older | 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | Israel;Netherlands;Germany;Switzerland;United Kingdom;France;Canada;Spain;Denmark;Australia | ||
| 27 | NCT04467957 (ClinicalTrials.gov) | October 1, 2020 | 19/6/2020 | Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis | Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis | Cystic Fibrosis | Drug: Initiation of CFTR Modulator;Drug: Hyperpolarized Xenon 129 | Children's Hospital Medical Center, Cincinnati | NULL | Not yet recruiting | 6 Years | 21 Years | All | 26 | Phase 4 | NULL |
| 28 | NCT03925194 (ClinicalTrials.gov) | October 1, 2020 | 19/4/2019 | A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF | A Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic Fibrosis | Cystic Fibrosis, 10011762 | Drug: Anakinra | Heidelberg University | NULL | Not yet recruiting | 12 Years | N/A | All | 52 | Phase 2 | Germany |
| 29 | NCT04658277 (ClinicalTrials.gov) | October 1, 2020 | 31/8/2020 | Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations | Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations | Bronchiectasis Adult | Drug: Clarithromycin;Drug: Placebo | Chinese University of Hong Kong | NULL | Recruiting | 50 Years | N/A | All | 136 | N/A | Hong Kong |
| 30 | EUCTR2020-001762-11-GB (EUCTR) | 17/09/2020 | 23/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2019-000750-63-PL (EUCTR) | 15/09/2020 | 21/07/2020 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Phase 2 | United States;Serbia;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Poland;Belgium;Netherlands | ||
| 32 | NCT04531410 (ClinicalTrials.gov) | September 1, 2020 | 18/8/2020 | NETwork of Linoleic Acid Supplementation in Cystic Fibrosis | Double-blind Randomized Controlled Study of Linoleic Acid Supplementation for 1 Year in Patients With Cystic Fibrosis - Influence on Clinical Status and Metabolism | Cystic Fibrosis | Dietary Supplement: linoleic acid supplementation;Dietary Supplement: oleic acid supplementation | Karolinska Institutet | European Society of Pediatric Gastroenterology, Hepatology and Nutrition | Enrolling by invitation | 5 Years | 15 Years | All | 90 | N/A | Italy;Norway;Poland |
| 33 | NCT04460586 (ClinicalTrials.gov) | September 1, 2020 | 1/7/2020 | Pharmacokinetics of Omadacycline in Cystic Fibrosis | Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Omadacycline Injection [Nuzyra];Drug: Omadacycline Oral Tablet [Nuzyra] | Paul Beringer | Paratek Pharmaceuticals Inc | Not yet recruiting | 18 Years | N/A | All | 12 | Phase 4 | United States |
| 34 | NCT04509661 (ClinicalTrials.gov) | September 1, 2020 | 22/4/2020 | Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation | Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial | Bronchiectasis Adult | Drug: LABA/LAMA or Placebo inhalation | Shanghai Pulmonary Hospital, Shanghai, China | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | Phase 4 | NULL |
| 35 | NCT04496921 (ClinicalTrials.gov) | September 2020 | 21/7/2020 | Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis | Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis : A Pilot Study | Cystic Fibrosis | Dietary Supplement: Vitamin K supplementation, dose #1;Dietary Supplement: Vitamin K supplementation, dose #2 | Institut de Recherches Cliniques de Montreal | Université de Montréal | Not yet recruiting | 18 Years | N/A | All | 40 | N/A | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2020-001762-11-HU (EUCTR) | 26/08/2020 | 02/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 37 | NCT04378153 (ClinicalTrials.gov) | August 25, 2020 | 4/5/2020 | Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy | A Master Protocol to Test the Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy (SIMPLIFY) | Cystic Fibrosis | Other: Discontinuation of hypertonic saline (HS);Other: Continuation of hypertonic saline (HS);Other: Discontinuation of dornase alfa (dnase);Other: Continuation of dornase alfa (dnase) | David Nichols, MD | Cystic Fibrosis Foundation;Dartmouth-Hitchcock Medical Center;University of Washington | Recruiting | 12 Years | N/A | All | 800 | N/A | United States |
| 38 | NCT04530383 (ClinicalTrials.gov) | August 22, 2020 | 24/8/2020 | A Trial of Metformin for Improving CFTR Function in CFRD | An Open Label Phase 2 Trial of Metformin for Improving CFTR Function in CFRD | Cystic Fibrosis-related Diabetes;Cystic Fibrosis | Drug: Metformin Hydrochloride | University of Kansas Medical Center | NULL | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 39 | EUCTR2019-003554-86-DK (EUCTR) | 19/08/2020 | 27/03/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Australia;Denmark;Israel;Netherlands;Germany;United Kingdom;Switzerland | ||
| 40 | NCT04381429 (ClinicalTrials.gov) | August 17, 2020 | 30/4/2020 | Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes | Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes : MIRE Trial | Cystic Fibrosis-related Diabetes | Drug: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP);Drug: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid) | University Hospital, Strasbourg, France | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 4 | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2019-003554-86-DE (EUCTR) | 14/08/2020 | 12/03/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | Switzerland;Germany;United Kingdom;France;Canada;Spain;Denmark;Australia;Israel;Netherlands | ||
| 42 | NCT04375514 (ClinicalTrials.gov) | August 10, 2020 | 30/4/2020 | Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis | A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-ENaC in Normal Healthy Volunteers and Safety, Tolerability and Efficacy in Patients With Cystic Fibrosis | Cystic Fibrosis, Pulmonary | Drug: ARO-ENaC;Drug: Placebo | Arrowhead Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 54 | Phase 1;Phase 2 | Australia;New Zealand |
| 43 | EUCTR2016-004558-13-PT (EUCTR) | 27/07/2020 | 20/04/2020 | 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) | 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 II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;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 Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;France;Portugal;Greece;Canada;Argentina;Poland | ||
| 44 | NCT04553419 (ClinicalTrials.gov) | July 27, 2020 | 11/9/2020 | Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF | Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF (ASAP-CF) Clinical Research Protocol | Cystic Fibrosis | Drug: Cephalexin;Drug: Placebo | University of British Columbia | The Hospital for Sick Children | Recruiting | 3 Years | 16 Years | All | 86 | Phase 3 | Canada |
| 45 | NCT04058210 (ClinicalTrials.gov) | July 21, 2020 | 13/8/2019 | VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes) | VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR Mutation | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 12 Years | N/A | All | NULL | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT04375878 (ClinicalTrials.gov) | July 20, 2020 | 30/4/2020 | OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis | OPTION 2: A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | Exocrine Pancreatic Insufficiency (EPI);Cystic Fibrosis (CF) | Drug: MS1819;Drug: Porcine PERT | AzurRx BioPharma, Inc. | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States;Poland |
| 47 | NCT04458129 (ClinicalTrials.gov) | July 8, 2020 | 30/6/2020 | Polyethylene Glycol and Intestinal Inflammation in Cystic Fibrosis | EFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDREN | Cystic Fibrosis | Drug: Treatment with polyethylene glycol (Macrogol 4000) | University Hospital, Bordeaux | NULL | Not yet recruiting | 4 Years | 17 Years | All | 23 | Phase 2 | NULL |
| 48 | EUCTR2016-004558-13-GR (EUCTR) | 07/07/2020 | 14/05/2020 | Treatment for bronchiectasis not due to cystic fibrosis. | 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 II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;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 Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;France;Canada;Greece;Argentina;Poland | ||
| 49 | NCT04279769 (ClinicalTrials.gov) | July 3, 2020 | 10/2/2020 | Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis | A Phase 1b Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: CB-280;Drug: Placebos | Calithera Biosciences, Inc | NULL | Recruiting | 18 Years | N/A | All | 32 | Phase 1 | United States |
| 50 | NCT04353817 (ClinicalTrials.gov) | June 19, 2020 | 16/4/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes | A Phase 3b, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA;Other: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Recruiting | 6 Years | 11 Years | All | 108 | Phase 3 | Australia;Canada;Denmark;France;Germany;Israel;Netherlands;Spain;Switzerland;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT04415268 (ClinicalTrials.gov) | June 9, 2020 | 28/5/2020 | Combined Effect of CFTR Protein Modulator Drugs and Exercise in Cystic Fibrosis | Combined Effect of CFTR Protein Modulator Drugs and Exercise on Pulmonary Function, Fitness, Sweat Test and Quality of Life in Children With Cystic Fibrosis | Cystic Fibrosis in Children | Behavioral: Exercise;Behavioral: Unsupervised exercise;Drug: CFTR Modulators | Universidad Europea de Madrid | NULL | Recruiting | 6 Years | 18 Years | All | 11 | N/A | Spain |
| 52 | NCT04362761 (ClinicalTrials.gov) | May 4, 2020 | 22/4/2020 | A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy | A Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 172 | Phase 3 | Australia;Belgium;Germany;United Kingdom |
| 53 | EUCTR2019-003554-86-GB (EUCTR) | 01/05/2020 | 01/04/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - Phase 3b Study of ELX/TEZ/IVA in CF subjects 6 Through 11 Years of Age | 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: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;Switzerland;United Kingdom | ||
| 54 | NCT04294043 (ClinicalTrials.gov) | May 1, 2020 | 1/3/2020 | IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) | A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study) | Nontuberculous Mycobacterium Infection | Drug: Gallium nitrate | Chris Goss | Cystic Fibrosis Foundation | Not yet recruiting | 18 Years | N/A | All | 40 | Phase 1 | United States |
| 55 | ChiCTR2000031817 | 2020-04-30 | 2020-04-11 | Evaluation and comparison of quality of life between acetylcysteine tablets and placebo in patients with non cystic fibrosis bronchiectasis | A Randomized, Double-Blinded, Placebo-Controlled, Multiple-Center Clinical Trial to Compare the Quality of Life of Acetylcysteine Tablets 600 Mg BID Treatment With Placebo in Patients With Non-Cystic Fibrosis Bronchiectasis | bronchiectasia | experimental group:Acetylcysteine;control group:placebo; | West China Hospital, Sichuan University | NULL | Pending | 18 | Both | experimental group:79;control group:40; | Phase 4 | China | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | EUCTR2019-003455-11-DE (EUCTR) | 08/04/2020 | 09/12/2019 | Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects | 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: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | ||
| 57 | EUCTR2019-004958-29-FR (EUCTR) | 07/04/2020 | 04/06/2020 | Polyethylene glycol and intestinal inflammation in cystic fibrosis | EFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDREN - MUCOLAX | 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] | Trade Name: FORLAX 4 g, poudre pour solution buvable en sachet | CHU de Bordeaux | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 2 | France | ||
| 58 | EUCTR2019-004940-31-DK (EUCTR) | 24/03/2020 | 24/03/2020 | Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial | Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial | GI pains and fat malabsorption in cysticfibrosis patients with pancreas insufficiency MedDRA version: 20.1;Level: LLT;Classification code 10025479;Term: Malabsorption syndrome;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Creon 10.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN Trade Name: Creon 25.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN Trade Name: Creon 40.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN | Terese Katzenstein | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Denmark | ||
| 59 | NCT04118010 (ClinicalTrials.gov) | March 13, 2020 | 4/10/2019 | Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis | Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis | Cystic Fibrosis;Dysbiosis | Drug: Vitamin D3;Drug: Placebo vitamin D3;Drug: Inulin;Drug: Placebo Inulin | Emory University | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 4 | United States |
| 60 | EUCTR2018-000378-30-DE (EUCTR) | 04/03/2020 | 06/06/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic 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] | AlgiPharma AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | EUCTR2018-000378-30-GB (EUCTR) | 03/03/2020 | 26/06/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic 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: OligoG CF-5/20 - 17.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 27.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 37.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | ||
| 62 | NCT04235140 (ClinicalTrials.gov) | February 24, 2020 | 15/1/2020 | Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation | A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation | Cystic Fibrosis | Drug: LUM/IVA | Vertex Pharmaceuticals Incorporated | NULL | Enrolling by invitation | 12 Months | N/A | All | 50 | Phase 3 | United States;Canada |
| 63 | NCT04166396 (ClinicalTrials.gov) | February 17, 2020 | 14/11/2019 | Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis | Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Resveratrol;Dietary Supplement: NR;Dietary Supplement: Placebo | Virginia Commonwealth University | NULL | Active, not recruiting | 18 Years | N/A | All | 36 | N/A | United States |
| 64 | NCT04183790 (ClinicalTrials.gov) | February 17, 2020 | 28/11/2019 | Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 6 Years | N/A | All | 64 | Phase 3 | United States;Australia;Canada;Ireland;United Kingdom |
| 65 | EUCTR2019-000955-16-AT (EUCTR) | 28/01/2020 | 07/01/2020 | Characterization of lung concentrations of the antibiotics piperacillin/tazobactam and levofloxacin | Pulmonary pharmacokinetics of piperacillin/tazobactam and levofloxacin in patients with chronic obstructive pulmonary disease or cystic fibrosis: Comparison of epithelial lining fluid, in-vivo microdialysis and tissue biopsy | Pneumonia;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Piperacillin/Tazobactam Kabi - Fresenius Kabi Austria INN or Proposed INN: piperacillin Other descriptive name: PIPERACILLIN INN or Proposed INN: tazobactam Other descriptive name: TAZOBACTAM Trade Name: Levofloxacin Kabi INN or Proposed INN: levofloxacin Other descriptive name: LEVOFLOXACIN HEMIHYDRATE | Medical University of Vienna | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 4 | Austria | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2018-003831-31-ES (EUCTR) | 24/01/2020 | 02/12/2019 | MS1819-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 | Exocrine 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] | AzurRx | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Hungary;Spain | |||
| 67 | EUCTR2019-000833-37-DE (EUCTR) | 23/01/2020 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 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 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Trikafta Product Name: 100-mg ELX (VX-455) / 50-mg TEZ / 75-mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 68 | EUCTR2018-002835-76-NL (EUCTR) | 22/01/2020 | 17/09/2019 | A 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 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 INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy | ||
| 69 | EUCTR2019-000833-37-NL (EUCTR) | 22/01/2020 | 17/09/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 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 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy | ||
| 70 | EUCTR2019-003455-11-GB (EUCTR) | 17/01/2020 | 09/12/2019 | Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects | 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] | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2018-004652-38-IE (EUCTR) | 15/01/2020 | 17/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Cystic Fibrosis MedDRA version: 20.0;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] | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 481 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Germany;United Kingdom;Switzerland | |||
| 72 | NCT04259970 (ClinicalTrials.gov) | January 13, 2020 | 15/1/2020 | Hyperpolarized Imaging for New Treatments | Hyperpolarized Imaging for New Treatments (HyPOINT) Study | Cystic Fibrosis | Drug: Initiation of CFTR Modulator | Children's Hospital Medical Center, Cincinnati | University of Virginia;University of Wisconsin, Madison;The Hospital for Sick Children | Recruiting | 6 Years | 18 Years | All | 64 | Phase 4 | United States;Canada |
| 73 | NCT04301856 (ClinicalTrials.gov) | January 1, 2020 | 21/2/2020 | Response to CFTR Modulators in CF Patients Under 18 Years | Evaluation of the Response to CFTR Modulators in Patients With Cystic Fibrosis Less Than 18 Years of Age | Cystic Fibrosis in Children | Drug: CFTR Modulators | Societe Francaise de la Mucoviscidose | NULL | Recruiting | N/A | 18 Years | All | 600 | France | |
| 74 | NCT04206436 (ClinicalTrials.gov) | December 18, 2019 | 18/12/2019 | CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis | CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis | Cystic Fibrosis;Bone Loss;Muscle Loss | Drug: Cftr Modulators | Indiana University | Cystic Fibrosis Foundation | Enrolling by invitation | 18 Years | N/A | All | 60 | United States | |
| 75 | NCT03894657 (ClinicalTrials.gov) | December 18, 2019 | 12/2/2019 | Validation 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 Fibrosis | Cystic Fibrosis;Homozygous F508del Mutation | Diagnostic Test: Nasal brushing;Other: Sputum sample;Other: blood sample;Drug: Orkambi | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 5 Years | N/A | All | 104 | N/A | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT04210427 (ClinicalTrials.gov) | December 12, 2019 | 18/12/2019 | Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit | Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit | Cystic Fibrosis Gastrointestinal Disease | Drug: Polyethylene Glycol 3350;Device: SmartPill Motility System & PillCam Patency Capsule | St. Louis University | NULL | Recruiting | 18 Years | 40 Years | All | 15 | Phase 4 | United States |
| 77 | NCT03969888 (ClinicalTrials.gov) | December 11, 2019 | 30/5/2019 | A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 | A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | Cystic Fibrosis | Drug: ABBV-3067;Drug: Placebo ABBV-3067;Drug: ABBV-2222;Drug: Placebo ABBV-2222 | AbbVie | NULL | Recruiting | 18 Years | N/A | All | 189 | Phase 2 | United States;Belgium;Canada;Czechia;France;Hungary;Netherlands;New Zealand;Poland;Romania;Serbia;Slovakia;Spain;United Kingdom |
| 78 | NCT03988816 (ClinicalTrials.gov) | December 6, 2019 | 14/6/2019 | Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With 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 Study | Bronchiectasis Adult | Drug: Roflumilast;Drug: Placebo oral tablet | University of Sao Paulo General Hospital | FAPESP - Fundação de Apoio à Pesquisa do Estado de São Paulo | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | Brazil |
| 79 | NCT04058366 (ClinicalTrials.gov) | December 5, 2019 | 14/8/2019 | Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 251 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;United Kingdom |
| 80 | NCT04135495 (ClinicalTrials.gov) | November 25, 2019 | 16/8/2019 | A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele | A 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 Allele | Cystic Fibrosis | Drug: ELX-02 | Eloxx Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 8 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | EUCTR2019-003178-25-HU (EUCTR) | 19/11/2019 | 20/11/2019 | A study of safety, tolerability and effect of SNSP113 in Cystic Fibrosis | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Effect of Inhaled SNSP113 in Adult Subjects with Cystic Fibrosis | 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: SNSP113 Product Code: SNSP113 INN or Proposed INN: not assigned Other descriptive name: PAAG15 | Synspira Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 2 | Hungary | ||
| 82 | EUCTR2019-000833-37-ES (EUCTR) | 19/11/2019 | 09/08/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 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] | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | |||
| 83 | EUCTR2018-000966-12-DE (EUCTR) | 18/11/2019 | 25/06/2019 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic Fibrosis | A 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 Allele | Cystic 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 Code: ELX-02 INN or Proposed INN: Not Assigned | Eloxx Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 2 | Israel;Germany | ||
| 84 | EUCTR2019-000750-63-FR (EUCTR) | 15/11/2019 | 22/08/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Phase 2 | Serbia;United States;France;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom | |||
| 85 | EUCTR2018-004652-38-GB (EUCTR) | 06/11/2019 | 19/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Cystic Fibrosis MedDRA version: 20.0;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] | Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445 /TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 481 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Germany;Switzerland;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT04126473 (ClinicalTrials.gov) | November 5, 2019 | 16/8/2019 | A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele | A 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 Allele | Cystic Fibrosis | Drug: ELX-02 | Eloxx Pharmaceuticals, Inc. | NULL | Recruiting | 16 Years | N/A | All | 16 | Phase 2 | Germany;Israel;Australia |
| 87 | EUCTR2019-000261-21-GB (EUCTR) | 05/11/2019 | 05/06/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM) 1 | A 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 fibrosis - BALANCE - CF(TM) 1 | 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: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 88 | EUCTR2018-000378-30-AT (EUCTR) | 04/11/2019 | 05/07/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic 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] | AlgiPharma AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | |||
| 89 | EUCTR2019-000750-63-GB (EUCTR) | 31/10/2019 | 26/06/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067 | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom | ||
| 90 | EUCTR2019-000750-63-NL (EUCTR) | 31/10/2019 | 05/08/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | EUCTR2018-002835-76-GB (EUCTR) | 29/10/2019 | 27/06/2019 | A 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 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 INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 92 | EUCTR2019-000833-37-GB (EUCTR) | 29/10/2019 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 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 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 93 | NCT04176328 (ClinicalTrials.gov) | October 25, 2019 | 8/11/2019 | Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients | An Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution. | Neupharma Srl | Sintesi Research Srl;Aptuit Srl;Pari Pharma GmbH | Completed | 18 Years | N/A | All | 12 | Phase 1 | Italy |
| 94 | NCT03924947 (ClinicalTrials.gov) | October 23, 2019 | 18/4/2019 | A 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 Fibrosis | Cystic Fibrosis | Drug: Pancrelipase | AbbVie | NULL | Recruiting | 12 Years | N/A | All | 28 | Phase 4 | United States;Spain |
| 95 | NCT04437641 (ClinicalTrials.gov) | October 22, 2019 | 26/3/2020 | Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children | Impact of Pediatrician Intervention on the Smoking Habits of Parents of Children With Cystic Fibrosis, Type 1 Diabetes or Children Hospitalized for a First Episode of Bronchiolitis. | Tobacco Consumption;Bronchiolitis | Other: Tobacco questionnaire | University Hospital, Toulouse | NULL | Recruiting | 18 Years | 65 Years | All | 600 | France | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | EUCTR2019-000833-37-IE (EUCTR) | 21/10/2019 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 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] | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | |||
| 97 | EUCTR2018-002835-76-DE (EUCTR) | 21/10/2019 | 03/07/2019 | A 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 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 INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 98 | EUCTR2018-002835-76-IE (EUCTR) | 21/10/2019 | 28/06/2019 | A 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 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 INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 99 | EUCTR2018-004652-38-DK (EUCTR) | 18/10/2019 | 28/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Cystic Fibrosis MedDRA version: 20.0;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] | Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445 /TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 506 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Australia;Denmark;Israel;Germany;United Kingdom;Switzerland | ||
| 100 | EUCTR2019-000833-37-DK (EUCTR) | 17/10/2019 | 09/07/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 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 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Belgium;Spain;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | EUCTR2018-002835-76-DK (EUCTR) | 16/10/2019 | 09/07/2019 | A 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 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 INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Belgium;Spain;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 102 | EUCTR2019-000261-21-ES (EUCTR) | 10/10/2019 | 05/07/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler | A 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 fibrosis | 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: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Spain;United States;France;Canada;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 103 | EUCTR2018-001695-38-GB (EUCTR) | 09/10/2019 | 19/08/2019 | Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years | A 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 Age | 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-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Trade Name: Kalydeco 150 mg film-coated tablets Product Name: IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Product Name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | United States;Canada;Ireland;Australia;United Kingdom | ||
| 104 | EUCTR2019-000261-21-SE (EUCTR) | 08/10/2019 | 29/04/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler | A 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 fibrosis | 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: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 105 | EUCTR2019-000261-21-BE (EUCTR) | 07/10/2019 | 29/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler – BALANCE – CF(TM)1 | A 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 fibrosis – BALANCE – CF(TM)1 | 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: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | NCT04105972 (ClinicalTrials.gov) | October 3, 2019 | 24/9/2019 | A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del | A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 176 | Phase 3 | Australia;Belgium;Germany;United Kingdom |
| 107 | NCT04090294 (ClinicalTrials.gov) | October 1, 2019 | 21/8/2019 | Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis | Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: Roflumilast | Assiut University | NULL | Not yet recruiting | 18 Years | 75 Years | All | 35 | Early Phase 1 | NULL |
| 108 | EUCTR2019-000750-63-BE (EUCTR) | 27/09/2019 | 07/08/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Spain;Belgium;Netherlands;United Kingdom | |||
| 109 | NCT04059094 (ClinicalTrials.gov) | September 16, 2019 | 15/8/2019 | A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1 | A 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 Fibrosis - BALANCE - CF™ 1 | Cystic Fibrosis | Drug: BI 1265162;Drug: Placebo | Boehringer Ingelheim | NULL | Terminated | 12 Years | N/A | All | 52 | Phase 2 | United States;Belgium;Canada;France;Germany;Spain;Sweden;United Kingdom |
| 110 | EUCTR2019-001735-31-GB (EUCTR) | 13/09/2019 | 24/06/2019 | A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic Fibrosis | A Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects | 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: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: ELEXACAFTOR Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | EUCTR2018-003970-28-NL (EUCTR) | 12/09/2019 | 09/05/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | 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: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom | ||
| 112 | NCT04056702 (ClinicalTrials.gov) | September 5, 2019 | 27/7/2019 | Impact 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 Changes | Cystic Fibrosis | Drug: Elexacaftor-tezacaftor-ivacaftor exposure | Jennifer Taylor-Cousar | Cystic Fibrosis Foundation | Active, not recruiting | 18 Years | 89 Years | All | 30 | United States | |
| 113 | NCT04038710 (ClinicalTrials.gov) | September 5, 2019 | 26/7/2019 | Clinical 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 Fibrosis | Drug: Triple combination therapy | National Jewish Health | NULL | Active, not recruiting | 12 Years | N/A | All | 8 | United States | |
| 114 | NCT04039087 (ClinicalTrials.gov) | September 5, 2019 | 28/7/2019 | Sildenafil Exercise: Role of PDE5 Inhibition | Mechanisms of Exercise Intolerance in Cystic Fibrosis: Role of PDE5 Inhibition | Cystic Fibrosis | Drug: Sildenafil 40mg oral capsule;Drug: Placebo Oral capsule | National Jewish Health | Augusta University;Cystic Fibrosis Foundation | Recruiting | 9 Years | N/A | All | 40 | Phase 2;Phase 3 | United States |
| 115 | NCT03506061 (ClinicalTrials.gov) | September 4, 2019 | 13/4/2018 | Trikafta in Cystic Fibrosis Patients | iPS Cell Response to CFTR Modulators: Study of Trikafta in CF Patients Carrying Partial Function Mutations | Cystic Fibrosis | Drug: Trikafta | Emory University | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 12 Years | N/A | All | 22 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | NCT04006873 (ClinicalTrials.gov) | September 3, 2019 | 2/7/2019 | Gut Imaging for Function & Transit in Cystic Fibrosis Study 2 | A Randomised Crossover Pilot Study of the Effects of Tezacaftor/Ivacaftor and Ivacaftor on Gastrointestinal Function Using Magnetic Resonance Imaging Parameters in People With Cystic Fibrosis | Cystic Fibrosis | Drug: Tezacaftor/Ivacaftor + Ivacaftor;Drug: Placebo oral tablet | Nottingham University Hospitals NHS Trust | Vertex Pharmaceuticals Incorporated;Cystic Fibrosis Foundation;Cystic Fibrosis Trust;University of Nottingham;Nottingham University Hospitals Charity | Active, not recruiting | 12 Years | 40 Years | All | 12 | Phase 2 | United Kingdom |
| 117 | EUCTR2019-000750-63-HU (EUCTR) | 03/09/2019 | 01/07/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067 | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Phase 2 | Serbia;France;United States;Czech Republic;Hungary;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom | ||
| 118 | EUCTR2019-000833-37-FR (EUCTR) | 02/09/2019 | 12/07/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 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 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 119 | NCT04302428 (ClinicalTrials.gov) | August 29, 2019 | 6/3/2020 | Zinc Status and Growth in Cystic Fibrosis | Zinc Status and Growth in Cystic Fibrosis | Cystic;Fibrosis | Biological: Serum Zn;Biological: Red Blood Cell Zn | Indiana University | NULL | Recruiting | 3 Months | 3 Years | All | 38 | United States | |
| 120 | NCT04058353 (ClinicalTrials.gov) | August 28, 2019 | 14/8/2019 | A 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 Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA;Drug: TEZ/IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 271 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Netherlands;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | EUCTR2018-003970-28-DE (EUCTR) | 12/08/2019 | 21/05/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | 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: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom | ||
| 122 | NCT04043806 (ClinicalTrials.gov) | August 9, 2019 | 31/7/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 458 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom |
| 123 | NCT03587961 (ClinicalTrials.gov) | August 1, 2019 | 3/7/2018 | Personalized Theratyping Trial | Personalized Theratyping Trial | Cystic Fibrosis | Drug: Symdeko | University of Alabama at Birmingham | NULL | Recruiting | 6 Years | N/A | All | 20 | Early Phase 1 | United States |
| 124 | NCT04058340 (ClinicalTrials.gov) | July 30, 2019 | 12/8/2019 | Taste Receptors Regulation in CF Patients | The Effects of Taste Receptors Regulation in Upper Airway Innate Immunity of CF Patients | Cystic Fibrosis | Dietary Supplement: lactizole nebulization;Other: Placebo | Medical Universtity of Lodz | NULL | Recruiting | 6 Years | N/A | All | 30 | N/A | Poland |
| 125 | EUCTR2019-000261-21-IE (EUCTR) | 26/07/2019 | 30/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM)1 | A 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 fibrosis - BALANCE - CF(TM)1 | 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] | Boehringer Ingelheim Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Germany;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | EUCTR2019-000261-21-FR (EUCTR) | 19/07/2019 | 21/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler | A 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 fibrosis | 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: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 127 | EUCTR2017-004134-29-DE (EUCTR) | 12/07/2019 | 05/03/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Mutation | 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 INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 128 | EUCTR2018-002496-18-NL (EUCTR) | 08/07/2019 | 13/02/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Fibrosis | 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-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Portugal;Germany;Netherlands;United Kingdom | ||
| 129 | EUCTR2018-003970-28-BE (EUCTR) | 04/07/2019 | 23/04/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | 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: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom | ||
| 130 | NCT03650712 (ClinicalTrials.gov) | July 1, 2019 | 18/7/2018 | EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis | EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis | Cystic Fibrosis-related Diabetes | Diagnostic Test: Oral glucose tolerance test;Diagnostic Test: Continuous glucose monitoring;Diagnostic Test: Dexa scan | Katie Larson Ode | NULL | Recruiting | 6 Years | N/A | All | 144 | N/A | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | NCT04302662 (ClinicalTrials.gov) | June 27, 2019 | 4/3/2020 | Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs | 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 | Cystic Fibrosis;Cystic Fibrosis Gastrointestinal Disease;Cystic Fibrosis of Pancreas | Drug: MS1819-SD | AzurRx SAS | NULL | Recruiting | 12 Years | N/A | All | 24 | Phase 2 | Hungary |
| 132 | NCT03597347 (ClinicalTrials.gov) | June 20, 2019 | 12/7/2018 | Trial of Inhaled Molgramostim in CF Subjects With NTM Infection | An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection | Mycobacterium Infections, Nontuberculous;Cystic Fibrosis (CF) | Drug: Molgramostim nebulizer solution;Device: PARI eFlow nebulizer system | Savara Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 133 | EUCTR2018-003970-28-GB (EUCTR) | 18/06/2019 | 17/04/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | 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: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom | ||
| 134 | NCT03734744 (ClinicalTrials.gov) | June 17, 2019 | 6/11/2018 | PK/PD of Vitamin D3 in Adults With CF | A Pilot Study Evaluating Single, High-dose Pharmacokinetics/Pharmacodynamics of Vitamin D3 in CF | Vitamin D Deficiency;Cystic Fibrosis | Dietary Supplement: Vitamin D3 | University of Southern California | NULL | Recruiting | 18 Years | N/A | All | 12 | N/A | United States |
| 135 | NCT03485456 (ClinicalTrials.gov) | May 29, 2019 | 26/3/2018 | DPI-Tobra-Kind Cyclops® in Children With Cystic Fibrosis | Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin Via the Cyclops® in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin | University Medical Center Groningen | NULL | Recruiting | 6 Years | 18 Years | All | 10 | Phase 1;Phase 2 | Netherlands |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | NCT04010799 (ClinicalTrials.gov) | May 27, 2019 | 10/6/2019 | A 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) Bronchiectasis | A 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 Bronchiectasis | Cystic Fibrosis;Non-Cystic Fibrosis Bronchiectasis | Drug: CHF 6333;Drug: Placebo | Chiesi Farmaceutici S.p.A. | NULL | Recruiting | 18 Years | N/A | All | 48 | Phase 1 | Germany |
| 137 | NCT03965832 (ClinicalTrials.gov) | May 24, 2019 | 24/5/2019 | HFNT During Exercise in CF | A Pilot Study to Evaluate the Feasibility of Using High-flow Nasal Therapy During Exercise in Patients With Cystic Fibrosis and Severe Lung Disease | Cystic Fibrosis | Device: HFNT during exercise;Device: Standard oxygen therapy/RA | The Leeds Teaching Hospitals NHS Trust | NULL | Recruiting | 18 Years | N/A | All | 20 | N/A | United Kingdom |
| 138 | EUCTR2018-002496-18-PT (EUCTR) | 20/05/2019 | 05/02/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Fibrosis | 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-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Portugal;Netherlands;Germany;United Kingdom | ||
| 139 | NCT03822455 (ClinicalTrials.gov) | May 16, 2019 | 29/1/2019 | A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis | A 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 Fibrosis | Drug: OligoG DPI | AlgiPharma AS | AlgiPharma Australia Pty. Ltd. | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 2 | Australia |
| 140 | EUCTR2017-003723-29-PL (EUCTR) | 09/05/2019 | 07/11/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | EUCTR2019-001314-41-NL (EUCTR) | 06/05/2019 | 06/05/2019 | This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we want to investigate the effect of the switch on the uptake, concentration in the blood an degradation of ivacaftor. | Kinetics of ivacaftor at Switch Orkambi Symkevi study - SOS | Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Orkambi: contains lumacaftor and ivacaftor Product Name: Orkambi Trade Name: Symkevi Product Name: Symkevi Trade Name: Kalydeco Product Name: Kalydeco | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Netherlands | |||
| 142 | EUCTR2018-002496-18-DE (EUCTR) | 02/05/2019 | 28/01/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Fibrosis | 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] | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 2 | Portugal;United States;Netherlands;Germany;United Kingdom | |||
| 143 | NCT03961516 (ClinicalTrials.gov) | May 1, 2019 | 16/5/2019 | Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis | Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis | Cystic Fibrosis;Cystic Fibrosis-related Diabetes;Cystic Fibrosis Liver Disease;Pancreatic Steatosis;Hepatic Steatosis | Device: Frequently Sampled Oral Glucose Tolerance Test and CGM;Radiation: MRI Pancreas and Liver | University Hospitals Cleveland Medical Center | NULL | Recruiting | 6 Years | 40 Years | All | 40 | United States | |
| 144 | NCT02748798 (ClinicalTrials.gov) | May 2019 | 19/4/2016 | Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders | Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders | Lung 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 Apnea | Drug: 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 Coil | Thunder Bay Regional Research Institute | Thunder Bay Regional Health Sciences Centre;St. Joseph's Care Group;Lakehead University | Unknown status | 18 Years | N/A | All | 160 | Early Phase 1 | Canada |
| 145 | NCT03903913 (ClinicalTrials.gov) | May 2019 | 15/2/2019 | Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis | A 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 Fibrosis | Cystic Fibrosis | Drug: S-1226 | SolAeroMed Inc. | NULL | Recruiting | 14 Years | 50 Years | All | 12 | Phase 2 | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | NCT03912233 (ClinicalTrials.gov) | April 30, 2019 | 10/4/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Fibrosis | Cystic Fibrosis | Drug: VX-121;Drug: TEZ;Drug: VX-561;Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 87 | Phase 2 | United States;Germany;Netherlands;Portugal;United Kingdom |
| 147 | NCT03911713 (ClinicalTrials.gov) | April 17, 2019 | 9/4/2019 | A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-561;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 77 | Phase 2 | United States;Australia;Belgium;Germany;Ireland;Netherlands;United Kingdom |
| 148 | NCT03795363 (ClinicalTrials.gov) | April 10, 2019 | 28/12/2018 | Orkambi Treatment in 2 to 5 Year Old Children With CF | Nutritional Impact of Orkambi Treatment in 2 to 5 Year Old Children Homozygous for F508del Mutations | Cystic Fibrosis | Drug: Orkambi | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Recruiting | 2 Years | 5 Years | All | 32 | United States | |
| 149 | NCT03870841 (ClinicalTrials.gov) | April 3, 2019 | 24/10/2018 | The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis | An Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus Infection | Aspergillosis;Cystic Fibrosis | Drug: PC945 | Pulmocide Ltd | NULL | Terminated | 18 Years | N/A | All | 4 | Phase 2 | United Kingdom |
| 150 | NCT03710538 (ClinicalTrials.gov) | April 1, 2019 | 20/6/2018 | The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis | The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Snack beverage;Behavioral: Exercise | Institut de Recherches Cliniques de Montreal | NULL | Recruiting | 18 Years | N/A | All | 14 | N/A | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | NCT03724955 (ClinicalTrials.gov) | April 2019 | 29/10/2018 | Pilot E2 for Hypogonadal Women With CFBD | Pilot Study Evaluating the Effects of Estradiol for Hypogonadal Women With Cystic Fibrosis and Osteopenia | Cystic Fibrosis Related Bone Disease | Drug: Estradiol 2 mg;Other: Placebo | Emory University | NULL | Withdrawn | 18 Years | N/A | Female | 0 | Phase 4 | United States |
| 152 | EUCTR2018-003831-31-HU (EUCTR) | 28/03/2019 | 09/10/2018 | MS1819-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 - MS1819/18/02 | Exocrine 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] | AzurRx | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Hungary | |||
| 153 | EUCTR2017-001259-29-GB (EUCTR) | 12/03/2019 | 21/12/2018 | A study to establish the tolerabilty and adverse effects in people with a severe form of Cystic Fibrosi (delta F 508 homozygous) when using a combination of two products - cyteamine (a licensed medicine being used in a new disease) and EGCG (a food supplement). | A PHASE 1B/2A STUDY TO ASSESS THE TOLERABILITY AND ADVERSE EFFECT PROFILE OF CYSTEAMINE (CYSTAGON) IN ADULTS AND CHILDREN WITH HOMOZYGOUS ?F508 CYSTIC FIBROSIS, IN PATIENTS TAKING EPIGALLOCATECHIN-3-GALLATE (EGCG, EPINERVE) FOOD SUPPLEMENTATION - Delta Dose Study | DeltaF508 Homozygous 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] | Trade Name: Cystagon Product Name: Cystagon INN or Proposed INN: cysteamine bitartrate Other descriptive name: 2-aminoethanethiol;2,3-dihydroxybutanedioic acid | University of LIverpool | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 1;Phase 2 | United Kingdom | ||
| 154 | EUCTR2018-002496-18-GB (EUCTR) | 08/03/2019 | 30/01/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Fibrosis | 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-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Portugal;United States;Netherlands;Germany;United Kingdom | ||
| 155 | NCT03902236 (ClinicalTrials.gov) | March 1, 2019 | 1/4/2019 | Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis | Evaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis | Cystic Fibrosis;Bronchiectasis | Other: Reaction Time and Postural Control;Other: Muscle oxygenation;Other: Exercise capacity;Other: Balance | Hacettepe University | NULL | Recruiting | 6 Years | 18 Years | All | 60 | Turkey | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | EUCTR2018-000185-11-AT (EUCTR) | 27/02/2019 | 19/10/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 Mutation | 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] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 157 | EUCTR2017-003723-29-NL (EUCTR) | 25/02/2019 | 20/06/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 158 | NCT03632525 (ClinicalTrials.gov) | February 22, 2019 | 21/6/2018 | Intravenous Iron in Adults With Cystic Fibrosis | A Pilot Trial of Intravenous Iron for the Treatment of Iron Deficiency in Adult Patients With Cystic Fibrosis | Cystic Fibrosis;Iron-deficiency | Drug: Ferric carboxymaltose | University of Oxford | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 4 | United Kingdom |
| 159 | NCT03783286 (ClinicalTrials.gov) | February 6, 2019 | 18/12/2018 | Ivacaftor Treatment in 6 Month to 2 Year Old CF Subjects | Nutritional Impact of Ivacaftor Treatment in 6 Month to 2 Year Old Children With CF Gating Mutations | Cystic Fibrosis | Drug: Ivacaftor | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Recruiting | 6 Months | 2 Years | All | 18 | United States | |
| 160 | EUCTR2017-002533-32-BE (EUCTR) | 17/01/2019 | 28/09/2018 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | NCT03746483 (ClinicalTrials.gov) | January 10, 2019 | 15/11/2018 | OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A 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 Fibrosis | Exocrine Pancreatic Insufficiency (EPI);Cystic Fibrosis (CF) | Drug: MS1819-SD;Drug: Porcine PERT | AzurRx BioPharma, Inc. | NULL | Completed | 18 Years | N/A | All | 32 | Phase 2 | United States;Poland |
| 162 | NCT04589897 (ClinicalTrials.gov) | January 7, 2019 | 24/9/2020 | Manuka Honey Sinus Rinse Study | A Pilot Study Investigating the Effects of a Manuka Honey Sinus Rinse on Sino-nasal Outcome Test Scores in Cystic Fibrosis Patients | Cystic Fibrosis;Infection, Bacterial | Device: Manuka honey sinus rinse;Device: Standard sinus rinse | Swansea University | University Hospital of Wales | Suspended | 18 Years | N/A | All | 40 | N/A | United Kingdom |
| 163 | EUCTR2018-000185-11-GR (EUCTR) | 20/12/2018 | 28/11/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 Mutation | 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] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 164 | EUCTR2015-004143-39-IT (EUCTR) | 19/12/2018 | 20/09/2018 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic 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;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] | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy | |||
| 165 | EUCTR2015-002743-33-NL (EUCTR) | 14/12/2018 | 18/07/2018 | A clinical trial to investigate the efficacy and safety of 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 I | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;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] | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;Greece;Belgium;Spain;Australia;Israel;Germany;Netherlands;New Zealand;Italy;United Kingdom;Switzerland | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | NCT03647228 (ClinicalTrials.gov) | December 13, 2018 | 23/8/2018 | A 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 Fibrosis | A 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 Fibrosis | Healthy Subjects;Cystic Fibrosis | Drug: IONIS-ENaCRx;Drug: Placebo | Ionis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | 50 Years | All | 98 | Phase 1 | Germany;United Kingdom |
| 167 | NCT03669614 (ClinicalTrials.gov) | December 7, 2018 | 30/8/2018 | SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects | A 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 Subjects | Cystic Fibrosis | Drug: inhaled AR-501;Drug: inhaled AR-501 placebo | Aridis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | 49 Years | All | 96 | Phase 1;Phase 2 | United States |
| 168 | NCT02323100 (ClinicalTrials.gov) | December 2, 2018 | 18/12/2014 | Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis) | A Double Blind, Placebo Controlled, Dose Escalation Trial of Glycerol Phenylbutyrate Corrector Therapy for Cystic Fibrosis | Cystic Fibrosis | Drug: Ravicti low dose;Drug: Ravicti high dose;Drug: Placebo | National Jewish Health | University of Alabama at Birmingham;Children's Hospital of Philadelphia;Johns Hopkins University;Horizon Pharma Ireland, Ltd., Dublin Ireland | Suspended | 18 Years | N/A | All | 36 | Phase 1;Phase 2 | United States |
| 169 | NCT03624101 (ClinicalTrials.gov) | December 1, 2018 | 7/8/2018 | Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations | Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations | Cystic Fibrosis | Drug: Tezacaftor/Ivacaftor | University of Alabama at Birmingham | NULL | Recruiting | 18 Years | N/A | All | 5 | Phase 4 | United States |
| 170 | EUCTR2017-003723-29-CZ (EUCTR) | 27/11/2018 | 09/07/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | NCT03756922 (ClinicalTrials.gov) | November 27, 2018 | 27/11/2018 | A DDI Study of FDL169 and FDL176 in Healthy Subjects | A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: FDL169;Drug: FDL176 | Flatley Discovery Lab LLC | NULL | Suspended | 18 Years | 55 Years | All | 78 | Phase 1;Phase 2 | United Kingdom |
| 172 | EUCTR2015-002743-33-GR (EUCTR) | 27/11/2018 | 14/11/2018 | A clinical trial to investigate the efficacy and safety of 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 I | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;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/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;Greece;Spain;Israel;Switzerland;United Kingdom;Italy;France;Belgium;Australia;Germany;Netherlands;New Zealand | ||
| 173 | EUCTR2017-003723-29-PT (EUCTR) | 19/11/2018 | 21/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden | ||
| 174 | EUCTR2018-000243-87-GB (EUCTR) | 19/11/2018 | 21/08/2018 | A study in people with cystic fibrosis who have a fungal lung infection, looking at the safety of inhaled PC945, it's effect on the body and how the body affects the drug. | An open-label study to assess the safety, pharmacokinetics and pharmacodynamics of inhaled PC945 in adult Cystic Fibrosis (CF) patients with persistent pulmonary Aspergillus fumigatus infection. | Pulmonary aspergillosis MedDRA version: 20.0;Level: LLT;Classification code 10059259;Term: Pulmonary aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: PC945 | Pulmocide Ltd | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | United Kingdom | ||
| 175 | EUCTR2017-003723-29-DE (EUCTR) | 19/11/2018 | 14/02/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Romania;Bulgaria;Germany;Netherlands;Sweden;United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | EUCTR2018-000185-11-NL (EUCTR) | 14/11/2018 | 19/09/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 Mutation | 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] | Trade Name: Trifakta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 177 | EUCTR2017-003319-21-BE (EUCTR) | 08/11/2018 | 21/08/2018 | Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | 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] - 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 INN or Proposed INN: None Other descriptive name: PTI-808 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 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 1;Phase 2 | United States;France;Canada;Belgium;Denmark;Germany;United Kingdom | ||
| 178 | NCT03748199 (ClinicalTrials.gov) | November 8, 2018 | 5/11/2018 | Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF | Phase-Ib/IIa Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Inhaled Multiple Doses of POL6014 in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: POL6014;Drug: Placebo | Santhera Pharmaceuticals | NULL | Unknown status | 18 Years | 55 Years | All | 40 | Phase 1;Phase 2 | Germany |
| 179 | NCT03617718 (ClinicalTrials.gov) | November 1, 2018 | 19/7/2018 | Project 2 Airway Potential Hydrogen (pH) in Asthma | Methods to Identify and Treat Severe Asthma Patients Project 2: Airway pH Phenotyping | Cystic Fibrosis;Asthma;Severe Persistent Asthma;Healthy | Drug: Glycine Buffer | University Hospitals Cleveland Medical Center | National Institutes of Health (NIH) | Recruiting | 18 Years | 50 Years | All | 75 | Phase 1;Phase 2 | United States |
| 180 | EUCTR2017-002968-40-PL (EUCTR) | 31/10/2018 | 29/06/2018 | A Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in subjects with cistic fibrosis | A 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 Mutation - Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects | 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-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | EUCTR2018-000185-11-GB (EUCTR) | 19/10/2018 | 04/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 Mutation | 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] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 182 | EUCTR2018-000185-11-CZ (EUCTR) | 15/10/2018 | 09/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 Mutation | 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] | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 183 | EUCTR2017-003723-29-GR (EUCTR) | 15/10/2018 | 08/08/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 184 | NCT03265288 (ClinicalTrials.gov) | October 10, 2018 | 21/2/2017 | Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults | APPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in Adults | Cystic Fibrosis | Drug: LAU-7b;Drug: Placebo oral capsule | Laurent Pharmaceuticals Inc. | Cystic Fibrosis Foundation | Recruiting | 18 Years | N/A | All | 136 | Phase 2 | United States;Australia;Canada |
| 185 | NCT03525574 (ClinicalTrials.gov) | October 9, 2018 | 2/5/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 Mutation | Cystic Fibrosis | Drug: VX-445;Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 507 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | NCT03691779 (ClinicalTrials.gov) | October 2, 2018 | 28/9/2018 | Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age | A 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 Age | Cystic Fibrosis | Drug: VX-445;Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 66 | Phase 3 | United States;Australia;Ireland;United Kingdom |
| 187 | EUCTR2018-000183-28-CZ (EUCTR) | 01/10/2018 | 09/07/2018 | A 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) | 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 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 188 | NCT03956589 (ClinicalTrials.gov) | October 1, 2018 | 2/5/2019 | Functional Respiratory Imaging and Orkambi in CF | Functional 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 Phe508del | Cystic Fibrosis | Drug: Orkambi | University Hospital, Antwerp | NULL | Terminated | 12 Years | N/A | All | 12 | Phase 4 | Belgium |
| 189 | EUCTR2018-000183-28-GR (EUCTR) | 01/10/2018 | 25/07/2018 | A 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) | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 190 | EUCTR2018-000184-89-GB (EUCTR) | 27/09/2018 | 04/07/2018 | A Phase 3 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) | 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: 100mg VX-445/50mg TEZ /75mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Product Name: 100 mg TEZ/150 mg IVA FDC Product Code: TEZ/IVA INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Belgium;Netherlands;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | EUCTR2018-000183-28-GB (EUCTR) | 27/09/2018 | 04/07/2018 | A 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) | 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 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 192 | EUCTR2016-004479-35-PL (EUCTR) | 26/09/2018 | 17/05/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A 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 Mutation - A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic F | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 193 | EUCTR2017-004134-29-PL (EUCTR) | 24/09/2018 | 13/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Mutation | 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] | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | |||
| 194 | EUCTR2017-003723-29-BG (EUCTR) | 21/09/2018 | 08/05/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 195 | EUCTR2018-000183-28-DE (EUCTR) | 20/09/2018 | 03/07/2018 | A 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) | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | EUCTR2018-002550-71-DE (EUCTR) | 12/09/2018 | 18/07/2018 | A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis | Phase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: POL6014 INN or Proposed INN: lonodelestat Other descriptive name: CYCLO[L-ALANYL-L-SERYL-L-ISOLEUCYL-L-PROLYL-L-PROLYL-L-GLUTAMINYL-L-LYSYL-L-TYROSYL-D-PROLYL-L-PROLYL-(2S)-2-AMINODECANOYL-L-ALPHA-GLUTAMYL-L-THREONYL] | Santhera Pharmaceuticals (Switzerland) Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 1;Phase 2 | Germany | ||
| 197 | EUCTR2018-000184-89-NL (EUCTR) | 12/09/2018 | 16/08/2018 | A Phase 3 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) | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Belgium;Netherlands;United Kingdom | |||
| 198 | EUCTR2018-000184-89-BE (EUCTR) | 07/09/2018 | 09/07/2018 | A Phase 3 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) | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Belgium;Netherlands;United Kingdom | |||
| 199 | EUCTR2018-000183-28-BE (EUCTR) | 07/09/2018 | 09/07/2018 | A 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) | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 200 | EUCTR2018-000185-11-BE (EUCTR) | 07/09/2018 | 17/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A 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 Mutation | 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] | Trade Name: Trikafta Product Name: 100 mg ELX /50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | EUCTR2018-000183-28-NL (EUCTR) | 03/09/2018 | 18/07/2018 | A 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) | 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 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 202 | EUCTR2017-004134-29-DK (EUCTR) | 29/08/2018 | 03/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Mutation | 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 INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 203 | EUCTR2017-002533-32-DK (EUCTR) | 28/08/2018 | 09/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | |||
| 204 | EUCTR2018-000183-28-SE (EUCTR) | 27/08/2018 | 29/06/2018 | A 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) | 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 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 205 | EUCTR2018-002579-16-SE (EUCTR) | 26/08/2018 | 16/07/2018 | Measurement 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® | Karolinska University Hospital, Stockholm CF center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 206 | EUCTR2018-000183-28-AT (EUCTR) | 24/08/2018 | 20/07/2018 | A 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) | 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 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 207 | EUCTR2018-002366-39-GB (EUCTR) | 23/08/2018 | 20/06/2019 | A pilot trial of intravenous iron for the treatment of low iron levels in adult patients with cystic fibrosis. | A pilot trial of intravenous iron for the treatment of iron deficiency in adult patients with cystic fibrosis - Intravenous iron in adults with cystic fibrosis | 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] | University of Oxford / Clinical Trials and Research Governance | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | United Kingdom | |||
| 208 | NCT03601637 (ClinicalTrials.gov) | August 23, 2018 | 18/7/2018 | Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del | A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis | Drug: LUM;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Recruiting | 12 Months | 23 Months | All | 40 | Phase 3 | United States;Canada |
| 209 | EUCTR2017-004134-29-GB (EUCTR) | 22/08/2018 | 23/02/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Mutation | 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 INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom | ||
| 210 | NCT03591094 (ClinicalTrials.gov) | August 21, 2018 | 6/7/2018 | Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect of PTI-428 in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: PTI-428;Drug: Placebo | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 40 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 211 | NCT03625466 (ClinicalTrials.gov) | August 10, 2018 | 7/8/2018 | A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An 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 F508del | Cystic Fibrosis | Drug: LUM;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 2 Years | 5 Years | All | 51 | Phase 2 | Germany |
| 212 | EUCTR2016-004479-35-FR (EUCTR) | 08/08/2018 | 04/06/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A 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 Mutation | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 213 | NCT03551691 (ClinicalTrials.gov) | August 7, 2018 | 29/5/2018 | PPIs and Fat Absorption in CF and EPI | Proton Pump Inhibitors and Fat Absorption in Subjects With Cystic Fibrosis and Pancreatic Insufficiency | Pancreatic Insufficiency;Cystic Fibrosis | Drug: Omeprazole 40mg Capsule;Drug: Placebo oral capsule | Children's Hospital of Philadelphia | Chiesi Farmaceutici S.p.A. | Recruiting | 12 Years | N/A | All | 24 | Phase 2 | United States |
| 214 | NCT03633526 (ClinicalTrials.gov) | August 3, 2018 | 27/7/2018 | Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age | A 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 Age | Cystic Fibrosis | Drug: VX-659/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Terminated | 6 Years | 11 Years | All | 18 | Phase 3 | United States |
| 215 | NCT03525548 (ClinicalTrials.gov) | August 3, 2018 | 2/5/2018 | A 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 Fibrosis | Drug: VX-445/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 113 | Phase 3 | United States;Belgium;Netherlands;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 216 | NCT03655249 (ClinicalTrials.gov) | August 1, 2018 | 28/8/2018 | Effects of AD on VI in Patients With CF | Effects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic Fibrosis | Cystic Fibrosis | Other: Autogenic drainage;Drug: Aerosoltherapy | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Recruiting | 6 Years | N/A | All | 30 | N/A | Belgium |
| 217 | NCT03593434 (ClinicalTrials.gov) | July 30, 2018 | 28/6/2018 | Airway Clearance Therapy on Hyperpolarized 129Xenon and MRI | The Effect of Airway Clearance Therapy on Hyperpolarized 129Xenon MRI Compared With Lung Clearance Index and Spirometry in Cystic Fibrosis | Cystic Fibrosis | Drug: hyperpolarized Xenon gas | Children's Hospital Medical Center, Cincinnati | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 6 Years | 21 Years | All | 20 | United States | |
| 218 | EUCTR2017-003319-21-DE (EUCTR) | 20/07/2018 | 09/04/2018 | Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | 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 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 1;Phase 2 | United States;France;Canada;Belgium;Denmark;Germany;United Kingdom | ||
| 219 | NCT03447262 (ClinicalTrials.gov) | July 13, 2018 | 21/2/2018 | A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy | A 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 Mutation | Cystic Fibrosis | Drug: VX-659;Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 484 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom |
| 220 | NCT03565692 (ClinicalTrials.gov) | July 1, 2018 | 31/5/2018 | Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor | Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor | Cystic Fibrosis | Biological: the lung mycobiota and microbiota profile;Biological: the gut mycobiota and microbiota profile | University Hospital, Bordeaux | Societe Francaise de la Mucoviscidose | Recruiting | 2 Years | N/A | All | 250 | France | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 221 | EUCTR2017-002968-40-DK (EUCTR) | 28/06/2018 | 24/06/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6 to 11 years who have Cystic Fibrosis | A 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 Mutation | 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] | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland | |||
| 222 | EUCTR2017-002968-40-GB (EUCTR) | 28/06/2018 | 07/03/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A 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 Mutation | 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-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom | ||
| 223 | EUCTR2017-003761-99-DE (EUCTR) | 27/06/2018 | 19/02/2018 | A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An 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 F508del | 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: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Orkambi 100 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 224 | EUCTR2017-003723-29-BE (EUCTR) | 27/06/2018 | 29/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 225 | EUCTR2017-002968-40-BE (EUCTR) | 26/06/2018 | 30/03/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A 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 Mutation | 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-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 226 | EUCTR2016-004479-35-BE (EUCTR) | 26/06/2018 | 30/03/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A 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 Mutation | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 227 | EUCTR2016-004479-35-DE (EUCTR) | 26/06/2018 | 06/04/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A 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 Mutation | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 228 | NCT03502070 (ClinicalTrials.gov) | June 26, 2018 | 29/3/2018 | Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules | A Multicenter, Human Factors Validation Study in Cystic Fibrosis Patients Aged 6 Years and Older to Evaluate the User Interface of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules | Cystic Fibrosis | Drug: Placebo;Device: Tobi Podhaler | Mylan Inc. | NULL | Completed | 6 Years | N/A | All | 47 | Phase 4 | United States |
| 229 | EUCTR2018-000098-61-GB (EUCTR) | 22/06/2018 | 01/06/2018 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in adult patients with cystic fibrosis | A Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered combination of GLPG3067, GLPG2222 and GLPG2737, in adult subjects with cystic fibrosis homozygous or heterozygous for F508del CFTR | 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: Body processes [G] - Genetic Phenomena [G05] | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | Serbia;France;United States;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;New Zealand;United Kingdom | |||
| 230 | NCT04278040 (ClinicalTrials.gov) | June 20, 2018 | 7/2/2020 | Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis | Safety, Tolerability and Efficacy of Ultra-low Doses of Alkylating Drug Melphalan Inhalations for the Treatment of Non-cystic Fibrosis Bronchiectasis | Non-cystic Fibrosis Bronchiectasis | Drug: Melphalan | Federal State Budgetary Institution, Pulmonology Scientific Research Institute | Moscow State University of Medicine and Dentistry | Recruiting | 18 Years | 70 Years | All | 7 | Phase 2 | Russian Federation |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 231 | NCT03525444 (ClinicalTrials.gov) | June 15, 2018 | 2/5/2018 | A 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 Fibrosis | Drug: VX-445/TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 405 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom |
| 232 | EUCTR2018-001573-24-BE (EUCTR) | 11/06/2018 | 08/05/2018 | Evaluation 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 imaging | Functional 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 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Antwerp University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Belgium | ||
| 233 | EUCTR2017-003723-29-SE (EUCTR) | 07/06/2018 | 01/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 234 | EUCTR2017-003319-21-GB (EUCTR) | 04/06/2018 | 03/07/2018 | Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | 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] - 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 INN or Proposed INN: None Other descriptive name: PTI-808 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 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 1;Phase 2 | France;United States;Canada;Belgium;Denmark;Germany;United Kingdom | ||
| 235 | NCT03540524 (ClinicalTrials.gov) | May 31, 2018 | 27/4/2018 | A 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 Fibrosis | Cystic Fibrosis | Drug: GLPG2451 dose regimen A;Drug: GLPG2451 dose regimen B;Drug: GLPG2222;Drug: GLPG2737 | Galapagos NV | NULL | Completed | 18 Years | N/A | All | 10 | Phase 1 | Belgium;Bulgaria;Germany;Greece;Netherlands;Serbia;Sweden;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 236 | EUCTR2016-001440-18-NL (EUCTR) | 30/05/2018 | 16/01/2018 | The 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 - IACI | cystic fibrosis and healthy subjects;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Ivacaftor Trade Name: claritromycin 500mg film coated tablets Product Name: Claritromycin Trade Name: Azithromycin 500 mg film-coated tablet Product Name: azithromycin Trade Name: Norvir 100 mg film-coated tablets Product Name: Norvir | university medical center utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 4 | Netherlands | ||
| 237 | NCT03482960 (ClinicalTrials.gov) | May 29, 2018 | 23/3/2018 | Comparison of 129Xe MRI With 19F MRI in CF Lung Disease | Comparison of 129Xe MRI With 19F MRI in CF Lung Disease | Cystic Fibrosis | Drug: Hyperpolarized Xenon gas;Drug: PFP | University of North Carolina, Chapel Hill | Cystic Fibrosis Foundation | Completed | 18 Years | N/A | All | 15 | Early Phase 1 | United States |
| 238 | EUCTR2017-003723-29-ES (EUCTR) | 21/05/2018 | 09/04/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;Serbia;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 | ||
| 239 | EUCTR2017-004134-29-ES (EUCTR) | 18/05/2018 | 21/03/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Mutation | 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 INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 240 | EUCTR2017-004133-82-ES (EUCTR) | 18/05/2018 | 15/03/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | 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 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 INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ireland;Australia;Germany;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 241 | EUCTR2017-004132-11-ES (EUCTR) | 18/05/2018 | 05/03/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | 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 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | |||
| 242 | EUCTR2017-003723-29-AT (EUCTR) | 17/05/2018 | 28/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 243 | NCT03462056 (ClinicalTrials.gov) | May 17, 2018 | 5/3/2018 | Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis | Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food | Washington University School of Medicine | Cystic Fibrosis Foundation | Completed | 2 Years | 12 Years | All | 16 | Phase 1;Phase 2 | United States |
| 244 | NCT03559062 (ClinicalTrials.gov) | May 17, 2018 | 5/6/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis | A 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 Mutation | Cystic Fibrosis | Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 67 | Phase 3 | Australia;Belgium;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom |
| 245 | EUCTR2017-004134-29-IE (EUCTR) | 15/05/2018 | 05/03/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Mutation | 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 INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 246 | EUCTR2017-003723-29-GB (EUCTR) | 11/05/2018 | 05/02/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 247 | NCT03375047 (ClinicalTrials.gov) | May 10, 2018 | 7/9/2017 | Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis | A 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 Fibrosis | Cystic Fibrosis | Drug: MRT5005;Drug: Normal saline | Translate Bio, Inc. | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 1;Phase 2 | United States |
| 248 | NCT03428334 (ClinicalTrials.gov) | May 10, 2018 | 26/1/2018 | Roflumilast in Non-CF Bronchiectasis Study | A 4-week Single-arm Study of Roflumilast in Stable-state Non-cystic Fibrosis Bronchiectasis | Non-cystic Fibrosis Bronchiectasis | Drug: Oral roflumilast | The University of Hong Kong | NULL | Completed | 18 Years | N/A | All | 20 | Phase 2 | Hong Kong |
| 249 | EUCTR2016-002749-42-NL (EUCTR) | 09/05/2018 | 29/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, 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: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Netherlands;Germany | ||
| 250 | EUCTR2017-004132-11-DK (EUCTR) | 08/05/2018 | 02/03/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | 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 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 251 | NCT03579173 (ClinicalTrials.gov) | May 8, 2018 | 25/6/2018 | Determinants of Early Cystic Fibrosis Lung Disease | Determinants of Early Cystic Fibrosis Lung Disease | Cystic Fibrosis in Children | Diagnostic Test: Infant PFT;Diagnostic Test: Lung Clearance Index;Diagnostic Test: Passive tidal breathing | Indiana University | NULL | Active, not recruiting | 1 Month | 5 Years | All | 55 | United States | |
| 252 | EUCTR2017-004133-82-GB (EUCTR) | 02/05/2018 | 14/06/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | 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 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ireland;Australia;Germany;United Kingdom | |||
| 253 | EUCTR2017-004132-11-GB (EUCTR) | 02/05/2018 | 23/02/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | 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 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 INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom | ||
| 254 | EUCTR2017-004132-11-IE (EUCTR) | 01/05/2018 | 05/03/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | 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 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | |||
| 255 | NCT03460990 (ClinicalTrials.gov) | May 1, 2018 | 1/3/2018 | A 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 Fibrosis | Drug: VX-659/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 116 | Phase 3 | United States;Australia;Germany;Ireland;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 256 | NCT03522831 (ClinicalTrials.gov) | May 1, 2018 | 19/3/2018 | CF Bronchodilation | A Double-blind Placebo-controlled Crossover Study to Assess the Effects of Bronchodilation on Dyspnea, Ventilatory Responses, and Exercise Tolerance in Adults With Cystic Fibrosis | Lung Diseases;Cystic Fibrosis | Drug: Salbutamol;Drug: Placebo | University of British Columbia | NULL | Recruiting | 19 Years | N/A | All | 20 | N/A | Canada |
| 257 | EUCTR2017-004133-82-IE (EUCTR) | 01/05/2018 | 05/03/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | 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 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 INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ireland;Australia;Germany;United Kingdom | ||
| 258 | EUCTR2017-002968-40-IE (EUCTR) | 27/04/2018 | 08/03/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6 to 11 years who have Cystic Fibrosis | A 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 Mutation | 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] | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 259 | EUCTR2017-002533-32-NL (EUCTR) | 26/04/2018 | 29/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 260 | EUCTR2017-003723-29-SK (EUCTR) | 26/04/2018 | 23/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 261 | EUCTR2017-004132-11-DE (EUCTR) | 25/04/2018 | 27/02/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | 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 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 INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Germany;United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;United Kingdom;Switzerland | ||
| 262 | NCT03537651 (ClinicalTrials.gov) | April 25, 2018 | 15/5/2018 | A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation | A 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 Mutation | Cystic Fibrosis | Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 6 Years | N/A | All | 130 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom |
| 263 | NCT03492567 (ClinicalTrials.gov) | April 25, 2018 | 3/4/2018 | Study 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 Fibrosis | Biological: Blood test | Assistance Publique - Hôpitaux de Paris | Vaincre la Mucoviscidose | Completed | 18 Years | N/A | All | 25 | N/A | France |
| 264 | EUCTR2016-004479-35-GB (EUCTR) | 24/04/2018 | 26/04/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A 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 Mutation | 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-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom | ||
| 265 | EUCTR2016-004479-35-DK (EUCTR) | 18/04/2018 | 22/02/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A 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 Mutation | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 266 | EUCTR2017-003723-29-HU (EUCTR) | 16/04/2018 | 27/02/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A 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 Fibrosis | Cystic 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 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 267 | NCT03527095 (ClinicalTrials.gov) | April 5, 2018 | 4/5/2018 | A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects | A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 11 | Phase 1 | United Kingdom |
| 268 | NCT03489629 (ClinicalTrials.gov) | April 3, 2018 | 29/3/2018 | STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) | STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) | Cystic Fibrosis | Drug: Trimethoprim Sulfamethoxazole (TMP/SMX);Drug: Minocycline;Drug: Mupirocin;Drug: Chlorhexidine Gluconate;Behavioral: Environmental Decontamination | University of North Carolina, Chapel Hill | University of Washington;Cook Children's Medical Center;Indiana University;University of Michigan;University of Texas Southwestern Medical Center;St. Louis Children's Hospital | Recruiting | 2 Years | 45 Years | All | 42 | Phase 2 | United States |
| 269 | EUCTR2017-002533-32-ES (EUCTR) | 29/03/2018 | 22/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | |||
| 270 | EUCTR2017-002533-32-PL (EUCTR) | 28/03/2018 | 18/01/2018 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Poland;Belgium;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 271 | EUCTR2017-002533-32-BG (EUCTR) | 23/03/2018 | 01/12/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 272 | EUCTR2017-002533-32-GB (EUCTR) | 22/03/2018 | 23/10/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United Kingdom;United States;Spain;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 273 | NCT03768089 (ClinicalTrials.gov) | March 20, 2018 | 5/12/2018 | Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis | A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-121;Drug: TEZ/IVA;Drug: IVA;Drug: Matched Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 114 | Phase 1;Phase 2 | Netherlands;United Kingdom |
| 274 | EUCTR2018-000126-55-NL (EUCTR) | 15/03/2018 | 15/05/2018 | A study to investigate the safety and the movement of the study drug VX-121 around the body in healthy people and patients with cystic fibrosis | A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis | 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-121 INN or Proposed INN: Not yet assigned Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 1;Phase 2 | Netherlands | ||
| 275 | EUCTR2017-002533-32-DE (EUCTR) | 15/03/2018 | 03/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Korea, Republic of;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 276 | NCT03447249 (ClinicalTrials.gov) | March 7, 2018 | 21/2/2018 | A 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 Fibrosis | Drug: VX-659/TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 385 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom |
| 277 | NCT03516331 (ClinicalTrials.gov) | March 7, 2018 | 24/4/2018 | A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects | A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects | Cystic Fibrosis | Drug: FDL176 & FDL169 coadministration | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 16 | Phase 1 | United Kingdom |
| 278 | NCT03421366 (ClinicalTrials.gov) | March 1, 2018 | 27/12/2017 | Modified Release Posaconazole in Patients With Cystic Fibrosis | Modified Release Posaconazole in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Posaconazole | Bayside Health | NULL | Recruiting | 18 Years | N/A | All | 20 | Australia | |
| 279 | NCT04411901 (ClinicalTrials.gov) | March 1, 2018 | 22/5/2020 | The Role of Vitamin D3 in Pediatric Bronchiectasis Severity | The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis) | Cystic Fibrosis and Non CF Bronchiectasis | Drug: Cholecalciferol (vitaminD3) | Heba Omara | NULL | Completed | 1 Year | 17 Years | All | 40 | Phase 2;Phase 3 | Egypt |
| 280 | NCT03367494 (ClinicalTrials.gov) | March 1, 2018 | 22/11/2017 | A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor | A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor | Cystic Fibrosis | Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide | Milton S. Hershey Medical Center | NULL | Active, not recruiting | 18 Years | N/A | All | 50 | N/A | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 281 | NCT03589313 (ClinicalTrials.gov) | February 12, 2018 | 9/7/2018 | Pharmacokinetics 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 Fibrosis | Drug: GLPG3067 single dose | Galapagos NV | NULL | Completed | 18 Years | N/A | Male | 6 | Phase 1 | Belgium |
| 282 | NCT03500263 (ClinicalTrials.gov) | January 30, 2018 | 9/4/2018 | Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Fibrosis | Cystic Fibrosis | Drug: PTI-808;Drug: Placebo;Drug: PTI-801;Drug: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 12 | Phase 1;Phase 2 | United Kingdom |
| 283 | EUCTR2017-002533-32-SE (EUCTR) | 30/01/2018 | 14/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | |||
| 284 | NCT03460704 (ClinicalTrials.gov) | January 29, 2018 | 14/2/2018 | Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS II) | 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 Bronchiectasis | Drug: Colistimethate sodium;Drug: Saline Solution | Zambon SpA | NULL | Recruiting | 18 Years | 90 Years | All | 420 | Phase 3 | United States;Argentina;Australia;Canada;France;Germany;Greece;Israel;Italy;New Zealand;Poland;Portugal |
| 285 | EUCTR2017-002533-32-IT (EUCTR) | 23/01/2018 | 05/11/2020 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study - N/A | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;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: INS1007 Product Code: [N/A] Product Name: INS1007 Product Code: [N/A] | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 286 | EUCTR2016-002749-42-GR (EUCTR) | 12/01/2018 | 03/10/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, 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: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 287 | NCT02653027 (ClinicalTrials.gov) | January 1, 2018 | 7/1/2016 | Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508del | A 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 Fibrosis | Drug: Lumacaftor-ivacaftor;Other: OGTT | Massachusetts General Hospital | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | N/A | NULL |
| 288 | NCT03451045 (ClinicalTrials.gov) | December 22, 2017 | 23/2/2018 | Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis | Cystic Fibrosis | Drug: Lenabasum 20 mg;Drug: Lenabasum 5 mg;Other: Placebo | Corbus Pharmaceuticals Inc. | Cystic Fibrosis Foundation | Active, not recruiting | 12 Years | N/A | All | 415 | Phase 2 | United States;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;United Kingdom |
| 289 | NCT03424252 (ClinicalTrials.gov) | December 18, 2017 | 31/1/2018 | An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects | A Phase 1, Open-label, Crossover, Randomised Study to Evaluate the Pharmacokinetic Profile of FDL169 Sublingual Formulations in the Fed State in Healthy Subjects | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 11 | Phase 1 | United Kingdom |
| 290 | EUCTR2016-002749-42-DK (EUCTR) | 15/12/2017 | 11/10/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, 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: 21.1;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 Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 291 | NCT03218917 (ClinicalTrials.gov) | December 1, 2017 | 11/7/2017 | Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis | Randomized, 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 Study | Non-Cystic Fibrosis Bronchiectasis | Drug: INS1007 10 mg oral tablet;Drug: INS1007 25 mg oral tablet;Drug: Placebo Oral Tablet | Insmed Incorporated | NULL | Completed | 18 Years | 85 Years | All | 256 | Phase 2 | United States;Australia;Belgium;Bulgaria;Denmark;Germany;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Singapore;Spain;United Kingdom;Sweden |
| 292 | NCT03474042 (ClinicalTrials.gov) | November 29, 2017 | 15/3/2018 | GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis | A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2737 in Orkambi-treated Subjects With Cystic Fibrosis Homozygous for the F508del Mutation | Cystic Fibrosis | Drug: GLPG2737;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | N/A | All | 22 | Phase 2 | Germany |
| 293 | NCT03219164 (ClinicalTrials.gov) | November 28, 2017 | 13/7/2017 | Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa Infection | Randomized, 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 | Pseudomonas Aeruginosa Respiratory Tract Infection;Cystic Fibrosis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Active, not recruiting | 3 Months | 18 Years | All | 149 | Phase 3 | United States;Austria;Belgium;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Spain;United Kingdom |
| 294 | EUCTR2016-002749-42-IT (EUCTR) | 24/11/2017 | 14/09/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, 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: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 295 | EUCTR2016-005110-22-DE (EUCTR) | 20/11/2017 | 23/06/2017 | A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis | Phase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: POL6014 | Santhera Pharmaceuticals (Switzerland) Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 1;Phase 2 | Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 296 | EUCTR2016-005230-30-IT (EUCTR) | 15/11/2017 | 05/11/2020 | A 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 Effectiveness | 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: SPX-101 Product Code: [SPX-101] INN or Proposed INN: SPX-101 | SPYRYX BIOSCIENCES, INC. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Portugal;France;Canada;Australia;United Kingdom;Italy | ||
| 297 | EUCTR2015-004263-36-DE (EUCTR) | 13/11/2017 | 06/09/2017 | Study 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. - Study to assess the effects of inhaled RPL554 in patients with cystic fibrosis. | Cystic 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 INN or Proposed INN: RPL554 Other descriptive name: RPL554 | Verona Pharma plc | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Germany;United Kingdom | ||
| 298 | NCT03206788 (ClinicalTrials.gov) | November 11, 2017 | 29/6/2017 | Losartan and Inflammation in Cystic Fibrosis | Losartan as Anti-inflammatory Therapy to Augment F508del Cystic Fibrosis Transmembrane (CFTR) Recovery | Cystic Fibrosis | Drug: Losartan;Drug: placebo | University of Miami | University of Alabama at Birmingham;Children's Hospital Medical Center, Cincinnati;University of Kansas Medical Center;Cystic Fibrosis Foundation | Terminated | 12 Years | N/A | All | 7 | Phase 2 | United States |
| 299 | EUCTR2017-000540-18-DE (EUCTR) | 08/11/2017 | 13/09/2017 | Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued Orkambi | 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 Mutation | 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] | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | France;United States;Germany | |||
| 300 | EUCTR2017-002181-42-DE (EUCTR) | 27/10/2017 | 28/07/2017 | GLPG2737 on top of Orkambi in subjects with cystic fibrosis | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del mutation | 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: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 301 | EUCTR2016-002749-42-GB (EUCTR) | 09/10/2017 | 25/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, 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: 21.1;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 Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 302 | EUCTR2017-000797-11-NL (EUCTR) | 06/10/2017 | 30/05/2017 | A Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | 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-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Belgium;Australia;Netherlands | ||
| 303 | NCT03309358 (ClinicalTrials.gov) | September 28, 2017 | 5/10/2017 | A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis | A 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 Inflammation | Drug: Inhaled SNSP113;Drug: Inhaled Placebo | Synspira, Inc. | NULL | Terminated | 18 Years | 50 Years | All | 32 | Phase 1 | United Kingdom |
| 304 | NCT02566044 (ClinicalTrials.gov) | September 27, 2017 | 18/9/2015 | Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis | A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Inhaled QBW276 in Patients With Cystic Fibrosis | Pulmonary Cystic Fibrosis | Other: Placebo;Drug: QBW276 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 16 | Phase 1;Phase 2 | United States;Germany;United Kingdom |
| 305 | NCT03181932 (ClinicalTrials.gov) | September 26, 2017 | 1/6/2017 | A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients | A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients | MRSA;Cystic Fibrosis | Drug: Vancomycin inhalation powder;Drug: Placebo inhalation powder | Savara Inc. | NULL | Active, not recruiting | 6 Years | N/A | All | 200 | Phase 3 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 306 | EUCTR2016-002749-42-DE (EUCTR) | 22/09/2017 | 02/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, 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: 21.1;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 Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 307 | EUCTR2017-000571-85-GB (EUCTR) | 19/09/2017 | 11/05/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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 Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | Pancreatic Exocrine Insufficiency due to Cystic 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 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom | ||
| 308 | EUCTR2016-002749-42-BE (EUCTR) | 18/09/2017 | 24/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, 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: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 309 | EUCTR2017-000571-85-LT (EUCTR) | 15/09/2017 | 20/07/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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 Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | Pancreatic Exocrine Insufficiency due to Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123 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] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 310 | NCT02769637 (ClinicalTrials.gov) | September 7, 2017 | 10/5/2016 | Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF) | Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: PPI treatment | University of Colorado, Denver | Cystic Fibrosis Foundation | Terminated | 10 Years | 21 Years | All | 2 | United States | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 311 | NCT03771313 (ClinicalTrials.gov) | September 1, 2017 | 11/7/2018 | Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis | Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis | Cystic Fibrosis | Drug: Ceftaroline | Children's Hospital Medical Center, Cincinnati | NULL | Recruiting | 2 Years | 21 Years | All | 24 | Phase 4 | United States |
| 312 | NCT04468100 (ClinicalTrials.gov) | August 30, 2017 | 8/7/2020 | Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic Fibrosis | A Multicenter Prospective Randomized Comparative Study of Pharmacokinetics, Clinical Efficacy and Safety of Tigerase® (JSC GENERIUM, Russia) vs. Pulmozyme® (Hoffmann-La Roche, Switzerland) as Part of Complex Therapy in Patients With Cystic Fibrosis | Cystic Fibrosis;Fibrosis | Biological: Tigerase®;Biological: Pulmozyme® | AO GENERIUM | NULL | Completed | 18 Years | N/A | All | 100 | Phase 3 | Russian Federation |
| 313 | EUCTR2015-003040-39-NL (EUCTR) | 28/08/2017 | 23/01/2017 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A 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 infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom;Switzerland | |||
| 314 | EUCTR2016-005230-30-PT (EUCTR) | 28/08/2017 | 31/05/2017 | A 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 Effectiveness | 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: SPX-101 INN or Proposed INN: SPX-101 Product Name: SPX-101 INN or Proposed INN: SPX-101 | Spyryx Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;Portugal;Canada;Australia;Italy;United Kingdom | ||
| 315 | EUCTR2017-000797-11-BE (EUCTR) | 28/08/2017 | 15/06/2017 | A Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | 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-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) INN or Proposed INN: VX-561 Other descriptive name: VX-561 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 2 | United States;Belgium;Australia;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 316 | NCT03278314 (ClinicalTrials.gov) | August 27, 2017 | 6/9/2017 | Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis | Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: tezacaftor/ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 12 Years | N/A | All | NULL | ||
| 317 | NCT03093714 (ClinicalTrials.gov) | August 23, 2017 | 16/3/2017 | A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis Subjects | A 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 Mutation | Cystic Fibrosis | Drug: FDL169;Drug: Placebo | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 85 Years | All | 27 | Phase 1 | Australia;Czechia;Germany;United Kingdom |
| 318 | NCT03277196 (ClinicalTrials.gov) | August 16, 2017 | 6/9/2017 | A 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 Mutation | 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 Mutation | Cystic Fibrosis | Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Enrolling by invitation | N/A | 24 Months | All | 75 | Phase 3 | United States;Australia;Canada;Germany;Ireland;United Kingdom |
| 319 | EUCTR2016-004558-13-PL (EUCTR) | 14/08/2017 | 30/06/2017 | 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) | 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 II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;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 Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;France;Canada;Argentina;Poland | ||
| 320 | EUCTR2016-003585-11-GB (EUCTR) | 10/08/2017 | 10/07/2017 | Study to Evaluate the Safety and Efficacy of VX-659 drug in combination with other drugs in Subjects Aged 18 Years and Older With Cystic Fibrosis | A 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 Fibrosis | 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 Product Code: VX-659 INN or Proposed INN: VX-659 Other descriptive name: VX-659 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) INN or Proposed INN: Deuterated Ivacaftor Other descriptive name: VX-561 (CTP-656) | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;Ireland;Israel;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 321 | NCT03224351 (ClinicalTrials.gov) | August 8, 2017 | 18/7/2017 | A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A 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 Fibrosis | Cystic Fibrosis | Drug: TEZ/IVA;Drug: VX-659;Drug: IVA;Drug: Matched Placebos;Drug: TEZ;Drug: VX-561 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 124 | Phase 2 | United States;Ireland;Israel;United Kingdom |
| 322 | NCT03172793 (ClinicalTrials.gov) | August 8, 2017 | 9/5/2017 | Telavancin Pharmacokinetics in Cystic Fibrosis Patients | Pharmacokinetics and Tolerability of Telavancin at Differing Dosing Regimens in Cystic Fibrosis Adults Admitted With Acute Pulmonary Exacerbations | Cystic Fibrosis | Drug: Telavancin Injection | Joseph L. Kuti, PharmD | Cumberland Pharmaceuticals, Inc. | Completed | 18 Years | N/A | All | 18 | Phase 4 | United States |
| 323 | EUCTR2016-002749-42-AT (EUCTR) | 07/08/2017 | 27/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, 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: 21.1;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 Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 324 | EUCTR2016-002749-42-ES (EUCTR) | 04/08/2017 | 08/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, 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: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Greece;Belgium;Spain;Ireland;Austria;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 325 | EUCTR2017-001379-21-GB (EUCTR) | 01/08/2017 | 20/07/2017 | A 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 Mutation | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | United States;Canada;Ireland;Germany;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 326 | NCT03229252 (ClinicalTrials.gov) | August 1, 2017 | 14/7/2017 | An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis | 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) | Cystic Fibrosis | Drug: Placebo Inhalation Solution;Drug: SPX-101 | Spyryx Biosciences, Inc. | NULL | Completed | 18 Years | 50 Years | All | 91 | Phase 2 | Canada;France;Italy;Portugal;United Kingdom |
| 327 | NCT03258424 (ClinicalTrials.gov) | July 28, 2017 | 18/8/2017 | Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis on KALYDECO® as Background Therapy | A Phase I, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis. | Cystic Fibrosis | Drug: PTI-428;Drug: Placebo | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 15 | Phase 1 | United Kingdom |
| 328 | EUCTR2016-001214-24-DE (EUCTR) | 27/07/2017 | 10/04/2017 | A 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 Fibrosis | A 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 PTI428 | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: PTI-428 Product Code: PTI-428 | Proteostasis Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 1;Phase 2 | France;United States;Czech Republic;Canada;Denmark;Germany;Italy;United Kingdom | ||
| 329 | EUCTR2014-004915-35-DE (EUCTR) | 26/07/2017 | 14/10/2015 | Safety and effect of QBW276 in patients with cystic fibrosis | A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis | 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] | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 1;Phase 2 | United States;Germany;United Kingdom | |||
| 330 | NCT02819856 (ClinicalTrials.gov) | July 21, 2017 | 16/6/2016 | SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity | A 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 Ototoxicity | Ototoxicity | Drug: Placebo;Drug: SPI-1005 Ebselen 200mg Capsule x1;Drug: SPI-1005 Ebselen 200mg Capsule x2;Drug: SPI-1005 Ebselen 200mg Capsule x3 | Sound Pharmaceuticals, Incorporated | Medical University of South Carolina;Cystic Fibrosis Foundation | Enrolling by invitation | 18 Years | N/A | All | 80 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 331 | NCT03068312 (ClinicalTrials.gov) | July 18, 2017 | 24/2/2017 | A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C?T or D1152H CFTR Mutation | A 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 Mutation | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | N/A | All | 38 | Phase 3 | Israel |
| 332 | NCT03251092 (ClinicalTrials.gov) | July 17, 2017 | 7/8/2017 | Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis | A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults With Cystic Fibrosis | Healthy Volunteer - Complete;Cystic Fibrosis - Complete | Drug: PTI-808;Drug: Placebo;Drug: PTI-428;Drug: PTI-801 | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | 99 Years | All | 179 | Phase 1;Phase 2 | United States;Australia;Belgium;Canada;Denmark;France;Germany;New Zealand;United Kingdom |
| 333 | EUCTR2016-005230-30-GB (EUCTR) | 14/07/2017 | 03/05/2017 | A 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 Effectiveness | 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: SPX-101 INN or Proposed INN: SPX-101 Product Name: SPX-101 INN or Proposed INN: SPX-101 | Spyryx Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Portugal;France;Canada;Australia;Italy;United Kingdom | ||
| 334 | EUCTR2015-002743-33-PT (EUCTR) | 13/07/2017 | 10/07/2017 | 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) | 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 I | Non-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 INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;Greece;Spain;Israel;Switzerland;United Kingdom;Italy;France;Belgium;Australia;Germany;Netherlands;New Zealand | ||
| 335 | EUCTR2016-001214-24-DK (EUCTR) | 10/07/2017 | 28/04/2017 | A 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 Fibrosis | A 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 PTI428 | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: PTI-428 Product Code: PTI-428 Product Code: PTI-428 Product Code: PTI-428 | Proteostasis Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 1;Phase 2 | United States;France;Czech Republic;Canada;Denmark;Germany;United Kingdom;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 336 | NCT03450720 (ClinicalTrials.gov) | June 28, 2017 | 23/2/2018 | Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis | Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: GLPG2737 single dose | Galapagos NV | NULL | Completed | 18 Years | N/A | Male | 6 | Phase 1 | Belgium |
| 337 | NCT03173573 (ClinicalTrials.gov) | June 27, 2017 | 30/5/2017 | A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF Participants | A 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) Participants | Cystic Fibrosis | Drug: FDL176;Drug: Placebo | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 109 | Phase 1 | Australia |
| 338 | EUCTR2016-004033-25-ES (EUCTR) | 19/06/2017 | 31/03/2017 | Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis | Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial | Cystic 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;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Sodium bicarbonate INN or Proposed INN: Sodium Bicarbonate Other descriptive name: SODIUM BICARBONATE BP Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: Water for injections INN or Proposed INN: water for injections Other descriptive name: WATER FOR INJECTIONS, EP | Fundació Parc Taulí | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Spain | |||
| 339 | EUCTR2017-000571-85-HU (EUCTR) | 15/06/2017 | 13/04/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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 Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 340 | NCT03078088 (ClinicalTrials.gov) | June 15, 2017 | 1/3/2017 | Airway Alkalinization and Nasal Colonization | Airway Alkalinization and Nasal Colonization | Healthy Subjects;Cystic Fibrosis | Drug: Tham;Drug: Saline | Lakshmi Durairaj | NULL | Completed | 16 Years | N/A | All | 32 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 341 | NCT03020719 (ClinicalTrials.gov) | June 14, 2017 | 11/1/2017 | The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis | A Multi Center Placebo Controlled Double Blind Randomized Study Evaluating the Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Oral Glutathione;Drug: Placebo | University of Minnesota | Cystic Fibrosis Foundation | Completed | 2 Years | 11 Years | All | 60 | Phase 2 | United States |
| 342 | NCT03066453 (ClinicalTrials.gov) | June 13, 2017 | 23/2/2017 | Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis | Evaluation 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 Fibrosis | Drug: Tobi Inhalant Product;Drug: Nebcin | University Hospital, Lille | NULL | Recruiting | 8 Years | N/A | All | 97 | Phase 3 | France |
| 343 | NCT03154541 (ClinicalTrials.gov) | June 6, 2017 | 3/5/2017 | SynRinse Irrigation Pilot (SIP) Trial | SynRinse Irrigation Pilot (SIP) Trial | Sinusitis, Chronic;Cystic Fibrosis With Other Manifestations | Drug: Synrinse | University of Washington | NULL | Completed | 18 Years | N/A | All | 30 | Phase 1;Phase 2 | United States |
| 344 | EUCTR2017-000571-85-ES (EUCTR) | 01/06/2017 | 21/04/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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 Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 345 | NCT03093974 (ClinicalTrials.gov) | June 1, 2017 | 9/3/2017 | Long 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 Bronchiectasis | Drug: Colistimethate Sodium;Drug: Saline Solution | Zambon SpA | NULL | Active, not recruiting | 18 Years | N/A | All | 420 | Phase 3 | Australia;Belgium;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Portugal;Spain;Switzerland;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 346 | NCT03056989 (ClinicalTrials.gov) | May 31, 2017 | 15/2/2017 | A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis | A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: SPX-101 | Spyryx Biosciences, Inc. | NULL | Completed | 18 Years | 50 Years | All | 5 | Phase 1 | Canada |
| 347 | EUCTR2016-004477-40-ES (EUCTR) | 31/05/2017 | 10/03/2017 | A 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 alleles | A 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 mutation | Cystic 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 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | ||
| 348 | EUCTR2016-004558-13-FR (EUCTR) | 30/05/2017 | 20/03/2017 | 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) | 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 II | Non-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 INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 264 | Phase 3 | United States;France;Canada;Poland | ||
| 349 | NCT02950805 (ClinicalTrials.gov) | May 30, 2017 | 23/8/2016 | A Study to Assess the Effect of AZD5634 on Mucociliary Clearance, Safety, Tolerability and Pharmacokinetic Parameters in Patients With Cystic Fibrosis | A 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 Diseases | Drug: Placebo;Drug: AZD5634 | AstraZeneca | Parexel | Completed | 18 Years | 60 Years | All | 9 | Phase 1 | United States |
| 350 | EUCTR2015-002743-33-DE (EUCTR) | 29/05/2017 | 01/03/2017 | A 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-< |