Air    (DrugBank: -)

7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
3脊髄性筋萎縮症1
51全身性強皮症2
58肥大型心筋症2
85特発性間質性肺炎6
97潰瘍性大腸炎3
193プラダー・ウィリ症候群1
299嚢胞性線維症90

3. 脊髄性筋萎縮症 [臨床試験数:179,薬物数:102(DrugBank:26),標的遺伝子数:52,標的パスウェイ数:78
Searched query = "Spinal muscular atrophy", "Myelopathic muscular atrophy", "SMA I", "Werdnig-Hoffman disease", "SMA II", "Dubowitz disease", "SMA III", "Kugelberg-Welander disease", "SMA IV"
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.
1 / 179 trial found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT01522079January 201124/1/2012Spinal Muscular Atrophy and Cardiac Autonomic FunctionSpinal Muscular Atrophy and Cardiac Autonomic FunctionSpinal Muscular AtrophyProcedure: Air stacking manueverCentro Universitário Augusto MottaNULLCompleted5 Years25 YearsBoth9N/ANULL

51. 全身性強皮症 [臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
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.
2 / 466 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04627857January 1, 20216/11/2020Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic SclerosisEffect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic SclerosisScleroderma SystemicDevice: Manual toothbrush;Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss);Device: Sonic toothbrush;Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)University Hospital, Strasbourg, FranceNULLNot yet recruiting18 YearsN/AAll100N/ANULL
2NCT00204763January 200413/9/2005Comparison of Esophageal and Anorectal Manometry CathetersComparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry CathetersAchalasia;Nutcracker Esophagus;Scleroderma;Esophageal Spasm;Fecal IncontinenceDevice: Air filled balloon catheter;Device: Solid state catheterUniversity of UtahClinical InnovationsTerminated18 Years80 YearsBoth5Phase 4United States

58. 肥大型心筋症 [臨床試験数:92,薬物数:126(DrugBank:35),標的遺伝子数:40,標的パスウェイ数:141
Searched query = "Hypertrophic cardiomyopathy"
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.
2 / 92 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT04129905October 21, 201912/6/2019Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic CardiomyopathiesAssessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic CardiomyopathiesHypertrophic Cardiomyopathy;Endothelial DysfunctionBiological: BNP blood sample test;Diagnostic Test: Electrocardiogram;Diagnostic Test: Holter ECG;Diagnostic Test: Echocardiography;Diagnostic Test: Air venous plethysmography;Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD;Biological: Endothelial function biomarkersUniversity Hospital, BordeauxFédération Française de Cardiologie;Fondation Bordeaux Université;Amicus TherapeuticsNot yet recruiting18 YearsN/AAll40N/AFrance
2NCT03049995November 20162/2/2017Stress Echo 2020 - The International Stress Echo StudyThe International Stress Echo Study in Ischemic and Non-ischemic Heart DiseaseCoronary Artery Disease;Heart Failure;Hypertrophic Cardiomyopathy;Aortic Valve Disease;Athletes Heart;Tetralogy of Fallot;Pulmonary Arterial HypertensionProcedure: Left ventricular contractile reserve SE;Procedure: B-lines SE;Procedure: Left ventricular outflow tract gradient SE;Procedure: Diastolic function SE;Procedure: Mitral regurgitation SE;Procedure: Pulmonary hemodynamics SE;Procedure: Coronary flow reserve SEFatebenefratelli HospitalInstitute of Clinical Physiology, CNR, Pisa,Italy;Salerno Hospital, Italy;Monaldi Hospital, Napoli, Italy;University of Pisa, Italy;San Luca Hospital, Lucca, Italy;Careggi University Hospital, Florence, Italy;Federico II University, Napoli, Italy;San Carlo Public Hospital, Potenza, Italy;Royal Brompton & Harefield NHS Foundation Trust;Ospedale dell'Angelo, Venezia-Mestre, Italy;University of Parma;Hospital Clinics, Trieste, Italy;Hospital de Clinicas de Porto Alegre - Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil;Hospital San José, Criciuma, Brasil;Hospital San Vicente de Paulo, Passo Fundo, Brasil;University of Belgrade,Serbia;University of Szeged, Hungary;Elisabeth Hospital, Hodmezovasarhely, Hungary;Sandro Pertini Hospital, Rome, Italy;Hospital Clinics, Bari, Italy;Ospedale Nottola, Siena, Italy;University of Catania, Italy;Medika Cardiocenter, Saint Petersburg, Russian Federation;Acibadem City Clinic, University Hospital,Sofia,Bulgaria;Investigaciones Medicas, Buenos Aires, Argentina;Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian FederationRecruiting18 Years85 YearsAll300N/AItaly

85. 特発性間質性肺炎 [臨床試験数:514,薬物数:377(DrugBank:108),標的遺伝子数:97,標的パスウェイ数:204
Searched query = "Idiopathic interstitial pneumonia", "IIPs", "Idiopathic pulmonary fibrosis", "IPF", "Usual interstitial pneumonia", "UIP", "Non-specific interstitial pneumonia", "NSIP", "Acute interstitial pneumonia", "AIP", "Diffuse alveolar damage", "DAD", "COP", "Organizing pneumonia", "OP", "Desquamative interstitial pneumonia", "DIP", "Respiratory bronchiolitis - associated interstitial lung disease", "RB-ILD", "Lymphocytic interstitial pneumonia", "LIP"
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.
6 / 514 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1NCT03688334June 1, 201820/9/2018Acute Effects of Oxygen Supplementation Among IPF PatientsAcute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting HypoxemiaIdiopathic Pulmonary FibrosisDrug: Oxygen 40 %;Drug: Medical air (sham O2)George Papanicolaou HospitalNULLUnknown status18 Years80 YearsAll15N/AGreece
2NCT03050255November 201625/11/2016Short-term Effects of Supplemental Oxygen in Patients With IPFShort-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Other: Medical air;Other: Oxygen (2Liter/min);Other: Oxygen (4Liter/min)Schön Klinik Berchtesgadener LandLinde AGCompletedN/AN/AAll53N/AGermany
3JPRN-UMIN0000155082015/01/0124/10/2014A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosisUsing Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks.
Pirfenidone 1200-1800mg (control group)
Grant for Research on Diffuse Lung Disease from the Ministry of Health, Labour and Welfare of Japan.NULLComplete: follow-up complete40years-oldNot applicableMale and Female150Not selectedJapan
4JPRN-UMIN0000050982011/02/0118/02/2011A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia idiopathic pulmonary fibrosisambulatory oxygen
ambulatory air
Department of Respiratory Medicine and Allergology, Kinki University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
5JPRN-UMIN0000160452009/10/0326/12/2014A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosisUsing Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks.
Pirfenidone 1200-1800mg (control group)
Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo,NULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
6JPRN-UMIN0000252562009/01/0113/12/2016Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients idiopathic pulmonary fibrosisoxygen gas
air gas
Tosei General HospitalNULLComplete: follow-up completeNot applicable75years-oldMale and Female106Not appl1cableJapan

97. 潰瘍性大腸炎 [臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181
Searched query = "Ulcerative colitis"
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.
3 / 2,269 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1JPRN-UMIN0000188012015/08/2727/08/2015Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis ulcerative colitisColonosocopy using carbon dioxide insufflation
Colonosocopy using air insufflation
Osaka University, Graduate School of Medicine,Department of Gastroenterology and HepatologyNULLRecruiting16years-oldNot applicableMale and Female250Not selectedJapan
2NCT02144350August 201313/5/2014Hyperbaric Oxygen for Ulcerative ColitisHyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-center Randomized Double Blind Sham Controlled TrialUlcerative ColitisProcedure: Hyperbaric oxygen;Procedure: Sham Hyperbaric AirDartmouth-Hitchcock Medical CenterMayo Clinic;University of PittsburghTerminated18 YearsN/AAll18Phase 2/Phase 3United States
3NCT01790061November 20129/2/2013Standardized Fecal Microbiota Transplantation for Ulcerative ColitisEfficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative ColitisBacteria;Microbiota;Fecal Microbiota Transplantation;Inflammatory Bowel Disease;Ulcerative ColitisProcedure: Standardized FMT;Drug: Traditional treatmentsThe Second Hospital of Nanjing Medical UniversityAir Force Military Medical University, ChinaRecruiting6 Years80 YearsAll500Phase 2/Phase 3China

193. プラダー・ウィリ症候群 [臨床試験数:95,薬物数:104(DrugBank:27),標的遺伝子数:50,標的パスウェイ数:63
Searched query = "Prader-Willi syndrome"
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.
1 / 95 trial found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT03031626September 1, 201620/1/2017Oxygen Versus Medical Air for Treatment of CSA in Prader Will SyndromeComparison of Therapeutic Oxygen Versus Medical Air for the Treatment of Central Sleep Apnea in Infants and Children With Prader Willi Syndrome: A Proof of Concept StudySleep Apnea, Central;Prader-Willi SyndromeBiological: Medical Air vs OxygenThe Hospital for Sick ChildrenNULLRecruitingN/A2 YearsAll10Phase 4Canada

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.
90 / 1,592 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2020-001762-11-GB17/09/202023/07/2020A 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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
2NCT04509661September 1, 202022/4/2020Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow LimitationEfficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled TrialBronchiectasis AdultDrug: LABA/LAMA or Placebo inhalationShanghai Pulmonary Hospital, Shanghai, ChinaNULLNot yet recruiting18 YearsN/AAll200Phase 4NULL
3EUCTR2020-001762-11-HU26/08/202002/07/2020A 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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
4NCT04058340July 30, 201912/8/2019Taste Receptors Regulation in CF PatientsThe Effects of Taste Receptors Regulation in Upper Airway Innate Immunity of CF PatientsCystic FibrosisDietary Supplement: lactizole nebulization;Other: PlaceboMedical Universtity of LodzNULLRecruiting6 YearsN/AAll30N/APoland
5NCT03617718November 1, 201819/7/2018Project 2 Airway Potential Hydrogen (pH) in AsthmaMethods to Identify and Treat Severe Asthma Patients Project 2: Airway pH PhenotypingCystic Fibrosis;Asthma;Severe Persistent Asthma;HealthyDrug: Glycine BufferUniversity Hospitals Cleveland Medical CenterNational Institutes of Health (NIH)Recruiting18 Years50 YearsAll75Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
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Inclusion_
agemin
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agemax
Inclusion_
gender
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size
PhaseCountries
6NCT03593434July 30, 201828/6/2018Airway Clearance Therapy on Hyperpolarized 129Xenon and MRIThe Effect of Airway Clearance Therapy on Hyperpolarized 129Xenon MRI Compared With Lung Clearance Index and Spirometry in Cystic FibrosisCystic FibrosisDrug: hyperpolarized Xenon gasChildren's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)Recruiting6 Years21 YearsAll20United States
7EUCTR2016-002749-42-NL09/05/201829/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Netherlands;Germany
8EUCTR2016-002749-42-GR12/01/201803/10/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
9EUCTR2016-002749-42-DK15/12/201711/10/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 21.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
10EUCTR2016-002749-42-IT24/11/201714/09/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-002749-42-GB09/10/201725/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 21.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
12EUCTR2016-002749-42-DE22/09/201702/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 21.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
13EUCTR2016-002749-42-BE18/09/201724/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
14EUCTR2016-002749-42-AT07/08/201727/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 21.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
15EUCTR2016-002749-42-ES04/08/201708/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3France;United States;Greece;Belgium;Spain;Ireland;Austria;Israel;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03078088June 15, 20171/3/2017Airway Alkalinization and Nasal ColonizationAirway Alkalinization and Nasal ColonizationHealthy Subjects;Cystic FibrosisDrug: Tham;Drug: SalineLakshmi DurairajNULLCompleted16 YearsN/AAll32Phase 1United States
17EUCTR2015-003881-96-IT17/05/201605/11/2020Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosisPseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways. - Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic fibrosis
MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML
Product Name: NA
Product Code: [NA]
INN or Proposed INN: COLISTIMETATO SODICO
Other descriptive name: COLISTIN
AZIENDA OSPEDALIERO-UNIVERSITARIA MEYERNULLNot RecruitingFemale: yes
Male: yes
112Phase 3Italy
18NCT02722122May 201623/3/2016Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®A Proof-of-Concept, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®Cystic FibrosisDrug: AIR DNase™ProtalixNULLRecruiting12 YearsN/ABoth15Phase 2Israel
19EUCTR2015-002581-23-DE20/04/201626/10/2015A study of safety and efficacy of JBT-101 in cystic fibrosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis Cystic FibrosisCystic Fibrosis 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: 19.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom
20EUCTR2015-002581-23-FR23/12/201518/01/2016A study of safety and efficacy of JBT-101 in cystic fibrosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis Cystic Fibrosis Cystic Fibrosis 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: 18.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Corbus Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;France;Poland;Belgium;Israel;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-002581-23-GB22/12/201521/03/2016A study of safety and efficacy of JBT-101 in cystic fibrosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis Cystic Fibrosis Cystic Fibrosis 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: 19.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Corbus Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom
22EUCTR2015-002581-23-BE03/12/201512/10/2015A study of safety and efficacy of JBT-101 in cystic fibrosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis Cystic FibrosisCystic Fibrosis 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: 18.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom
23NCT02605590December 201510/11/2015Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult VolunteersA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AIR-DNase When Administered by Inhalation to Healthy Adult SubjectsCystic Fibrosis (CF)Drug: AIR DNase;Drug: PlaceboProtalixNULLCompleted18 Years55 YearsMale18Phase 1Israel
24NCT03391414August 201420/6/2012Effects of Inhaled Bicarbonate on Airway pH in Cystic FibrosisEffects of Inhaled Bicarbonate on Airway pH in Cystic FibrosisCystic FibrosisDrug: hypertonic bicarbonate;Drug: sodium chlorideJoseph PilewskiCystic Fibrosis Foundation TherapeuticsCompleted12 YearsN/AAll12Phase 1United States
25EUCTR2014-001401-41-NL29/07/201415/05/2014Once daily deep inhalation of tobramycin with smart nebulizer more effective to treat small airways disease in cystic fibrosis?Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis - TAPAS study in patients with CF Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Bramitob 300mg/4ml Nebuliser SolutionNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-000801-39-ES25/07/201425/04/2014Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens? eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1Level: LLTClassification code 10011764Term: Cystic fibrosis NOSSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Hungary;Spain;Ireland;Austria;Germany;Italy;Sweden
27EUCTR2011-000801-39-AT11/06/201424/04/2014Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1Level: LLTClassification code 10011764Term: Cystic fibrosis NOSSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Hungary;Ireland;Austria;Germany;Italy;Sweden
28EUCTR2011-000801-39-HU22/05/201403/04/2014Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1Level: LLTClassification code 10011764Term: Cystic fibrosis NOSSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Hungary;Ireland;Germany;Italy;Sweden
29NCT01937325February 20144/9/2013CPET in CF Patients With One G551D Mutation Taking VX770Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor)Cystic FibrosisDrug: ivacaftor;Drug: placeboThe AlfredNULLActive, not recruiting16 Years70 YearsBoth20Phase 4Australia
30EUCTR2013-004488-30-NL31/01/201411/12/2013Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CF Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Bramitob
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Haga HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-000801-39-IE07/05/201312/02/2013Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1Level: LLTClassification code 10011764Term: Cystic fibrosis NOSSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Ireland;Germany;Italy;Sweden
32NCT01586728October 201218/1/2012Oxygen Therapy in Cystic FibrosisIndication and Benefits of Nocturnal Oxygen Therapy in Cystic FibrosisCystic FibrosisOther: Air - oxygen;Other: Oxygen - AirAssistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseTerminated6 YearsN/ABoth8N/AFrance
33NCT02201082September 201220/2/2014Evaluation of the Timing of the Nebulization Related to the Physiotherapy SessionCystic FibrosisProcedure: Airway clearance technique;Drug: Amikacin nebulizationCliniques universitaires Saint-Luc- Université Catholique de LouvainNULLCompleted16 Years50 YearsBoth15N/ABelgium
34EUCTR2011-001255-36-AT25/06/201218/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
35EUCTR2011-000801-39-IT20/06/201221/06/2012Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens'eggs building a barrier in the respiratory tract against Pesudomonas germ in order to preventi infection with Pseudomonas in patients suffering from cystic fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially effects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbility and mortality. PA infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 14.1Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
MUKOVISZIDOSE E.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Germany;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2011-000801-39-BE26/04/201209/01/2012Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1Level: LLTClassification code 10011764Term: Cystic fibrosis NOSSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
37EUCTR2011-001362-18-DE19/03/201220/12/2011Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
MedDRA version: 14.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Spain;Poland;Germany;Italy
38EUCTR2011-001255-36-NL13/03/201219/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;France;Spain;Poland;Belgium;Ireland;Austria;Germany;Netherlands;Italy
39EUCTR2011-000801-39-SE08/02/201213/12/2011Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 14.1Level: LLTClassification code 10011764Term: Cystic fibrosis NOSSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
40EUCTR2011-001362-18-IT08/02/201222/02/2012Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria.Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety) Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa.
MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10056971Term: Infective exacerbation of chronic obstructive airways diseaseSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution
INN or Proposed INN: AZTREONAM
Other descriptive name: NA
GILEAD SCIENCES INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Germany;Spain;Italy;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2011-001255-36-BE07/02/201213/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2France;United States;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy
42EUCTR2011-001255-36-IE06/02/201224/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
43EUCTR2011-001255-36-IT27/01/201228/09/2012Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas aeruginosa (PA) Aztreonam Lysine for Pseudomonas Infection Eradication (ALPINE)study - ALPINE Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 15.0Level: PTClassification code 10056971Term: Infective exacerbation of chronic obstructive airways diseaseSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 15.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston Aztreonam 75 mg powder and solvent for nebuliser solution
INN or Proposed INN: AZTREONAM
GILEAD SCIENCES INC.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Spain;Ireland;Austria;Netherlands;Germany;Italy
44EUCTR2011-001362-18-ES25/01/201221/12/2011Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mgPowder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) Cystic fibrosis and chronic infection of lower respiratory tract withPseudomonas aeruginosa
MedDRA version: 14.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam solución para inhalación
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Germany;France;Spain;Italy;United States;Poland
45EUCTR2011-001255-36-DE16/01/201211/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;France;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
46NCT01731015January 201216/11/2012Imaging Lung Function Using Oxygen Enhanced MRIA Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast AgentCOPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways DiseaseDrug: Medical Grade OxygenHal C CharlesNULLCompleted18 Years90 YearsBoth15Phase 1United States
47NCT01404234December 201126/7/2011Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower AirwaysOpen-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower AirwaysCystic Fibrosis;Pseudomonas AeruginosaDrug: AZLIGilead SciencesNULLCompletedN/A12 YearsAll61Phase 3United States;France;Germany;Italy;Poland;Spain
48EUCTR2011-001255-36-ES23/11/201118/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for P.aeruginosa.
MedDRA version: 14.0Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Germany;Netherlands;Belgium;France;Ireland;Spain;Italy;United States;Poland;Austria
49EUCTR2011-000801-39-DE31/08/201104/04/2011Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 17.1Level: LLTClassification code 10011764Term: Cystic fibrosis NOSSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
50NCT02782312June 201117/5/2016Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis BronchiectasisSalmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis With Airway Limitation: a Prospective StudyBronchiectasisDrug: ICS+LABA;Other: routine therapyShanghai Pulmonary Hospital, Shanghai, ChinaNULLCompleted18 YearsN/ABoth120Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT01314716April 201111/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)BronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
52NCT01035853December 200917/12/2009Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa ColonizationSino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas AeruginosaCystic Fibrosis;Pseudomonas AeruginosaDrug: ColistinUniversity of JenaNULLCompleted6 YearsN/ABoth10Phase 2Germany
53NCT00999531October 200920/10/2009A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy VolunteersA Phase 1, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy VolunteersCystic Fibrosis;Mucociliary Clearance;Airway HydrationDrug: GS-9411;Drug: PlaceboGilead SciencesNULLCompleted18 Years65 YearsBoth24Phase 1Australia
54NCT00989807September 20092/10/2009Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic FibrosisExpanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease ProgressionCystic Fibrosis;Pseudomonas AeruginosaDrug: Aztreonam lysineGilead SciencesNULLApproved for marketing6 YearsN/ABothN/ACanada
55NCT00951522September 20093/8/2009A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male VolunteersA Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male VolunteersCystic Fibrosis;Mucociliary Clearance;Airway HydrationDrug: GS-9411;Drug: PlaceboGilead SciencesNULLCompleted18 Years45 YearsMale15Phase 1Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT01710449September 200917/10/2012Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With OxygenEvaluation of Regional Ventilation in Normal Subjects and Subjects With Airway and Lung Disorders (COPD, Asthma, Emphysema, Small Airway Disease and Cystic Fibrosis) Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen.COPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways DiseasesDrug: perfluorinated gas/oxygen mixtureHal C CharlesNULLCompleted18 YearsN/ABoth44Phase 1United States
57EUCTR2008-007877-19-DE15/06/200928/05/2009Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilotNasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
MedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis
Trade Name: Colistin CF
Product Name: Colistin CF
INN or Proposed INN: Colistimethat-Natrium
University of JenaNULLNot RecruitingFemale: yes
Male: yes
14Germany
58EUCTR2006-003275-12-NO03/06/200927/03/2009Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: Zitromax
Product Code: Zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNAFemale: yes
Male: yes
250Phase 4Denmark;Norway;Sweden
59ChiCTR-TRC-130039792009-05-072013-10-28Application of roxithromycin in patients with bronchiectasis in stable conditionEffect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasis BronchietasisRoxithromycin group:The patients received oral roxithromycin in roxithromycin group;Control group:The patients received no drug in control group;First Affiliated Hospital of Guangxi Medical UniversityNULLCompleted1870BothRoxithromycin group:26;Control group:26;China
60NCT00774072October 200816/10/2008Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa ColonizationNasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper AirwaysCystic Fibrosis;Pseudomonas AeruginosaDrug: Tobramycin (Gernebcin®)University of JenaNULLCompleted8 YearsN/ABoth9Phase 2Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT00630812September 200827/2/2008Long Term Administration of Inhaled Mannitol in Cystic FibrosisLong Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy StudyCystic FibrosisDrug: inhaled mannitol;Drug: Placebo comparatorPharmaxisethica Clinical Research Inc.;Europe: KasaConsult bvba, Hoegaarden, Belgium;Argentina: Resolution Latin America; Buenos Aires, ArgentinaCompleted6 YearsN/AAll318Phase 3United States;Argentina;Belgium;Canada;France;Germany;Netherlands
62EUCTR2008-000164-17-DE13/08/200826/05/2008Nasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilotNasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilot subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airwaysTrade Name: Gernebcin 80 mg
Product Name: Gernebcin 80 mg
INN or Proposed INN: tobramycin
University of JenaNULLNot RecruitingFemale: yes
Male: yes
14Germany
63NCT00712166May 20087/7/2008Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. AeruginosaA Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)Cystic Fibrosis;Lung Infection;Pseudomonas AeruginosaDrug: AZLI 75 mg three times daily (TID);Drug: Placebo three times daily (TID)Gilead SciencesNULLCompleted6 YearsN/AAll160Phase 3United States;Australia;Canada
64NCT00700050April 200816/6/2008Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis AirwaysModulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot StudyCystic FibrosisDrug: Hypertonic salineThe Hospital for Sick ChildrenNULLRecruitingN/A22 YearsBoth32Phase 3Canada
65NCT00541190October 20075/10/2007Absorptive Clearance in the Cystic Fibrosis AirwayAbsorptive Clearance in the Cystic Fibrosis AirwayCystic FibrosisOther: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPAUniversity of PittsburghNULLCompleted18 YearsN/AAll21N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2006-003275-12-DK23/05/200717/04/2007Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNot RecruitingFemale: yes
Male: yes
250Phase 4Denmark
67NCT00721071December 200621/7/2008Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic FibrosisDiagnostic Utility of Induced Sputum Using Hypertonic Saline to Evaluate Airway Infection and Inflammation in Cystic FibrosisCystic FibrosisDrug: Hypertonic SalineThe Hospital for Sick ChildrenNULLCompleted6 Years18 YearsBoth95Phase 2Canada
68EUCTR2005-003870-88-DE20/10/200628/08/2006Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4 Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction.Product Name: GSH (Glutathione)
Product Code: TAD 600
INN or Proposed INN: Glutathione
Other descriptive name: reduced glutathione
Mukoviszidose Institut gGmbH i. G.NULLNot RecruitingFemale: yes
Male: yes
160Germany
69NCT01463371October 200628/10/2011Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With BronchiectasisEffects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: AzithromycinInstituto de Investigacion Sanitaria La FeSociedad Valenciana de NeumologíaCompleted16 Years80 YearsBoth30N/ASpain
70NCT00128492August 20058/8/2005Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)A Phase 3, Open-label, Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3)Cystic FibrosisDrug: AZLI 75 mg two times a day (BID)/ three times a day (TID)Gilead SciencesNULLCompleted6 YearsN/AAll274Phase 3United States;Australia;Canada;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT00112359May 20051/6/2005International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. AeruginosaA Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)Cystic FibrosisDrug: AZLI 75 mg three times a day (TID);Drug: Placebo three times a day (TID)Gilead SciencesNULLCompleted6 YearsN/AAll166Phase 3United States;Australia;Canada;New Zealand
72NCT00104520February 20051/3/2005Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. AeruginosaA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)Cystic FibrosisDrug: AZLI 75 mg two times a day (BID)/three times a day (TID);Drug: Placebo two times a day (BID)/three times a day (TID)Gilead SciencesNULLCompleted6 YearsN/AAll211Phase 3United States
73NCT00097773September 200430/11/2004Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic FibrosisEffectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic FibrosisCystic Fibrosis;Pulmonary Disease, Chronic ObstructiveDrug: Tobramycin solution for inhalation (TOBI);Drug: Oral placebo;Drug: Oral ciprofloxacinSeattle Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation Therapeutics;CF Therapeutics Development Network Coordinating CenterCompleted1 Year12 YearsAll304Phase 2United States
74NCT00255242July 200416/11/2005Effect of Simvastatin on CF Airway InflammationEffect of Simvastatin on CF Airway InflammationCystic FibrosisDrug: Simvastatin treatment for 28 daysAkron Children's HospitalCystic Fibrosis Foundation TherapeuticsCompleted10 YearsN/ABoth40Phase 1United States
75NCT02010411June 20049/12/2013Alpha1 Antitrypsin Aerosol Therapy in Cystic FibrosisEffects of Prolastin Aerosol Therapy on Bacterial Density in the Airways of Patients With Cystic FibrosisCystic FibrosisDrug: Prolastin (drug)Université de SherbrookeNULLTerminated14 YearsN/ABoth17Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT00499720October 20039/7/2007Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway InfectionExpanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease ProgressionCystic Fibrosis;Pseudomonas Aeruginosa Airway InfectionDrug: Aztreonam Lysine for InhalationGilead SciencesNULLApproved for marketing6 YearsN/ABothN/AUnited States;Puerto Rico
77NCT00164021February 200113/9/2005The Prevalence and Significance of Gastro-oesophageal Reflux in Cystic Fibrosis Before and After Lung TransplantationThe Prevalence and Significance of Gastro-oesophageal Reflux in Adults With Cystic Fibrosis Before and After Lung Transplantation, Together With the Effects of Physiotherapy Airway Clearance Techniques on Gastro-oesophageal FunctionCystic FibrosisProcedure: Physiotherapy, exercise, percutaneous gastrostomy feeds;Drug: Anti-reflux pharmacotherapyBayside HealthThe Alfred;Monash UniversityRecruiting16 Years70 YearsBoth180N/AAustralia
78EUCTR2015-000395-97-Outside-EU/EEA02/02/2015A Clinical Trial to Evaluate the Effects of the drug Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and infection with the bacteria Pseudomonas aeruginosa (AIR-CF4)A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (AIR-CF4) Cystic Fibrosis with Mild Lung Disease and P. aeruginosa (AIR-CF4);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.Gilead Sciences Pty Ltd;Gilead Sciences Canada, Inc.NAFemale: yes
Male: yes
157United States;Australia;Canada
79EUCTR2020-001762-11-SE17/07/2020A 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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
80EUCTR2020-001762-11-DE17/09/2020A 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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2006-003275-12-SE07/07/2009Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 14.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: Azithromycin
Product Name: azithromycin
Product Code: azithromycin
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNAFemale: yes
Male: yes
250Phase 4Denmark;Norway;Sweden
82EUCTR2020-001762-11-AT10/08/2020A 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 Study 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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
83EUCTR2011-001255-36-Outside-EU/EEA02/02/2015Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 17.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
105Phase 2United States
84EUCTR2015-000396-26-Outside-EU/EEA02/02/2015Program to Give the Drug Aztreonam Lysine for Inhalation to Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease ProgressionExpanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
603United States
85EUCTR2011-001362-18-FR05/01/2012Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
MedDRA version: 14.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
60Phase 3United States;France;Spain;Poland;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2011-001362-18-Outside-EU/EEA02/02/2015Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
MedDRA version: 17.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
60Phase 3United States
87EUCTR2016-002749-42-IE26/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.1 Level: LLT Classification code 10068288 Term: Cystic fibrosis pulmonary exacerbation System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
88EUCTR2015-000397-36-Outside-EU/EEA03/02/2015Program to Give the Drug Aztreonamn Lysine for Inhalation to Canadian Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease ProgressionExpanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 17.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
45Canada
89EUCTR2011-001255-36-FR14/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.0Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
80Phase 2United States;France;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
90EUCTR2009-011740-19-Outside-EU/EEA02/02/2015Clinical Trial to Assess the Safety and Efficacy of Aztreonam for Inhalation Solution (AZLI) in patients with Cystic Fibrosis (CF) and Chronic Burkholderia Species InfectionPhase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects with Cystic Fibrosis (CF) and Chronic Burkholderia Species Infection Cystic Fibrosis subjects with chronic Burkholderia spp. infection of the airways.
MedDRA version: 17.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Canada