Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Congenital respiratory tract disorders

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44412   clinical trials with a EudraCT protocol, of which   7421   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    129 result(s) found for: Congenital respiratory tract disorders. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2015-003519-40 Sponsor Protocol Number: 03-CL-1202 Start Date*: 2016-02-18
    Sponsor Name:Windtree Therapeutics, Inc
    Full Title: A MULTINATIONAL, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF LUCINACTANT FOR INHALATION IN PRETERM NEONATES 26 TO 32 WEEKS GESTATIONAL AGE WITH RESPIRATOR...
    Medical condition: Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed) IE (Completed) NL (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2015-005624-26 Sponsor Protocol Number: 03-CL-1401 Start Date*: 2016-05-30
    Sponsor Name:Windtree Therapeutics, Inc. (formerly Discovery Laboratories, Inc.)
    Full Title: A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates 26 to 28 Weeks PMA.
    Medical condition: Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000106-32 Sponsor Protocol Number: 03-CL-1702 Start Date*: 2019-06-26
    Sponsor Name:Windtree Therapeutics, Inc.
    Full Title: A Multinational, Multicenter, Masked, Randomized, Parallel Group, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation versus nCPAP alone in Preterm Neonates 26 to 32 We...
    Medical condition: Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-000896-30 Sponsor Protocol Number: Uni-Koeln-439 Start Date*: 2009-02-09
    Sponsor Name:University of Cologne
    Full Title: Surfactant application during spontaneous breathing with CPAP or during mechanical ventilation in the therapy of IRDS in premature infants <27 weeks
    Medical condition: Idiopathic Respiratory Distress Syndrome (IRDS) in preterm infants
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004996-33 Sponsor Protocol Number: VX15-809-114 Start Date*: 2017-05-03
    Sponsor Name:Vertex Pharmaceuticals Incoporated
    Full Title: A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation
    Medical condition: Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001362-18 Sponsor Protocol Number: GS-US-205-0160 Start Date*: 2012-03-19
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: 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 Chron...
    Medical condition: cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10068288 Cystic fibrosis pulmonary exacerbation LLT
    14.1 10021881 - Infections and infestations 10070608 Infective pulmonary exacerbation of cystic fibrosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Ongoing) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000602-30 Sponsor Protocol Number: Kamada-AATInhaled-008 Start Date*: 2019-09-30
    Sponsor Name:Kamada Ltd.
    Full Title: A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of “Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha...
    Medical condition: Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% ≤ FEV1 ≤ 80% of predicted; FEV1/SVC ≤ 70%), and with no history of two or more moderat...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) GB (GB - no longer in EU/EEA) IE (Trial now transitioned) SE (Trial now transitioned) FI (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001711-67 Sponsor Protocol Number: VX18-659-106 Start Date*: 2019-08-21
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-659/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-000689-40 Sponsor Protocol Number: VX19-661-012 Start Date*: 2020-02-25
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability of a Granule Formulation of Tezacaftor and Ivacaftor Compared to a Fixed-dose Combination Tablet in Healt...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-004664-58 Sponsor Protocol Number: BESTCILIA-WP5 Start Date*: 2014-08-26
    Sponsor Name:Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
    Full Title: RANDOMIZED CONTROLLED TRIAL (RCT) TO DETERMINE THE EFFICACY AND SAFETY OF AZITHROMYCIN (AZN) MAINTENANCE THERAPY FOR 6 MONTHS IN SUBJECTS WITH PCD - A DOUBLE-BLIND, PARALLEL GROUP STUDY
    Medical condition: Primary ciliary dyskinesia (PCD)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10069713 Primary ciliary dyskinesia PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) DK (Prematurely Ended) GB (Prematurely Ended) NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003052-36 Sponsor Protocol Number: 19067 Start Date*: 2020-01-06
    Sponsor Name:The University of Nottingham
    Full Title: Triple Modality Functional Magnetic Resonance Lung Imaging in Cystic Fibrosis and Non-CF Bronchiectasis
    Medical condition: Cystic fibrosis (CF) Non-CF Bronchiectasis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2015-000398-11 Sponsor Protocol Number: GS-US-205-0170 Start Date*: 2015-02-03
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for t...
    Medical condition: Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001412-38 Sponsor Protocol Number: CQCC374X2201 Start Date*: 2017-07-27
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, parallel-group, placebo-controlled subject and investigator blinded study to assess the safety, tolerability, pharmacokinetics and efficacy of QCC374 in the treatment of pulmonary art...
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002366-39 Sponsor Protocol Number: 000000 Start Date*: 2018-08-23
    Sponsor Name:University of Oxford / Clinical Trials and Research Governance
    Full Title: A pilot trial of intravenous iron for the treatment of iron deficiency in adult patients with cystic fibrosis
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2016-002832-34 Sponsor Protocol Number: AZLI2016DN001 Start Date*: 2016-11-11
    Sponsor Name:Liverpool Heart & Chest Hospital
    Full Title: Aztreonam for inhalation for the treatment of acute exacerbations in cystic fibrosis. An open-label, randomised, cross-over pilot study of AZLI plus intravenous Colistin versus standard dual intrav...
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-011740-19 Sponsor Protocol Number: GS-US-205-0127 Start Date*: 2015-02-02
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Phase 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) a...
    Medical condition: Cystic Fibrosis subjects with chronic Burkholderia spp. infection of the airways.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-019802-17 Sponsor Protocol Number: 205.438 Start Date*: 2010-09-13
    Sponsor Name:Boehringer Ingelheim France
    Full Title: A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 μg administered once daily via the Respimat® device in pati...
    Medical condition: Cystic Fibrosis
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PT (Completed) HU (Completed) FR (Completed) SK (Completed) DE (Completed) GB (Completed) BE (Completed) CZ (Completed) IT (Completed) AT (Completed) IE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-000540-18 Sponsor Protocol Number: VX16-661-114 Start Date*: Information not available in EudraCT
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population ...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001735-31 Sponsor Protocol Number: VX18-445-109 Start Date*: 2019-09-13
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-004652-38 Sponsor Protocol Number: VX18-445-113 Start Date*: 2020-01-15
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) PL (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  5  6  7  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Oct 16 08:37:53 CEST 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA