Clinical trials: Cystic Fibrosis
Cystic Fibrosis in Children, Cystic Fibrosis
Sinus Disease in Young Children With Cystic Fibrosis
This is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young…
- Conditions
- Cystic Fibrosis in Children, Cystic Fibrosis, Chronic Rhinosinusitis (Diagnosis), Olfactory Disorder
- Trial name
- NCT06191640
- Testing
- Ivacaftor or elexacaftor/tezacaftor/ivacaftor
- Where
- 6 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of California, Los Angeles
Cystic Fibrosis
Impaired Secretory IgA and Mucosal Immunity in Cystic Fibrosis
This project entitled "Impaired secretory IgA and mucosal immunity in cystic fibrosis" is a research program which aims to determine, owing to national (KULeuven) and international (Descartes university Paris, university of…
- Trial name
- Forton2015 (NCT02308267)
- Testing
- Lung explants, Sputum, nasal fluid and serum, Bronchoscopy
- Where
- Belgium
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cystic Fibrosis
Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a…
- Trial name
- NCT01090908
- Testing
- Antibiotic
- Sponsor
- Aradigm Corporation
Cystic Fibrosis
Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and…
- Trial name
- NCT01684410
- Testing
- Alpha-1 HC 100 mg, Alpha-1 HC 200 mg
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Grifols Therapeutics LLC
Cystic Fibrosis
Use of a Biofilm Antimicrobial Susceptibility Assay to Guide Antibiotic Therapy
The purpose of this study is to determine whether choosing antibiotics based on a biofilm antimicrobial susceptibility assay rather than a conventional planktonic antimicrobial susceptibility assay to treat CF patients with…
- Trial name
- NCT00786513
- Testing
- Conventional antimicrobial susceptibility testing, Biofilm antimicrobial susceptibility testing
- Where
- 5 sites in Canada
- Volunteers
- 134 people
- Sponsor
- The Hospital for Sick Children
Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine…
- Trial name
- NCT02415959
- Testing
- Creon IR, Creon® (DR/GR)
- Where
- 17 sites in Czechia, Hungary and 2 more
- Volunteers
- 70 people
- Sponsor
- Abbott
Cystic Fibrosis
Evaluating the Impact of Chronic Rhinosinusitis on the Health-Related Quality of Life Among Adults With Cystic Fibrosis
Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous.
- Trial name
- NCT02003079
- Testing
- Cystic Fibrosis Questionnaire (Revised) for Teens/Adults
- Where
- Canada
- Volunteers
- 113 people
- Sponsor
- St. Paul's Hospital, Canada
Human Papillomavirus Infection
HPV Vaccination in Women With Cystic Fibrosis
The main risk factor for the development of cervical lesions is human papillomavirus (HPV) infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to 14, and catching up to girls aged 15 to 19…
- Trial name
- VACCIN-HPV-MUC (NCT03265743)
- Testing
- Self-report Written Questionnaire
- Where
- 3 sites in France
- Volunteers
- 74 people
- Sponsor
- Hospices Civils de Lyon
Cystic Fibrosis
A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects.
- Trial name
- NCT03227471
- Testing
- IVA, TEZ/IVA, VX-445
- Where
- 38 sites in United States, Australia and 2 more
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Chronic Rhinosinusitis, Cystic Fibrosis
Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical…
- Trial name
- Respire (NCT03145051)
- Testing
- Saline solution, Respimer Netiflow
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Laboratoire de la Mer
Cystic Fibrosis, Bacterial Infection
Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa. II.
- Trial name
- NCT00004829
- Testing
- tobramycin
- Volunteers
- 200 people
- Sponsor
- FDA Office of Orphan Products Development
Cystic Fibrosis
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects
This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and…
- Trial name
- NCT04926701
- Testing
- ETD001 single dose, ETD001 multiple twice daily doses, ETD001 multiple once daily doses
- Where
- United Kingdom
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Enterprise Therapeutics Ltd
Cystic Fibrosis
Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients
The purpose of this trial is to evaluate if the use of a newly developed lipid formulation versus fish oil would better enable the absorption of essential fatty acids after 12 weeks of supplementation.
- Trial name
- NCT02646995
- Testing
- modified lipid formulation, Fish oil
- Where
- Switzerland
- Volunteers
- 16 people
- Sponsor
- Société des Produits Nestlé (SPN)
Cystic Fibrosis
Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation
The purpose of this study is to determine whether the treatment with Ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR mutation) in the real life setting, after the drug has…
- Trial name
- IVACAFTOR1 (NCT02194881)
- Testing
- CF patients with a G551D mutation and treated with Ivacaftor
- Where
- France
- Volunteers
- 57 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Kartagener Syndrome, Cystic Fibrosis
Rare Genetic Disorders of the Breathing Airways
Mucociliary clearance, in which mucus secretions are cleared from the breathing airways, is the primary defense mechanism for the lungs.
- Conditions
- Kartagener Syndrome, Cystic Fibrosis, Pseudohypoaldosteronism, Primary Ciliary Dyskinesia
- Trial name
- NCT00323167
- Where
- 9 sites in United States, Canada
- Volunteers
- 367 people
- Sponsor
- University of North Carolina, Chapel Hill
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
- Trial name
- OPTION (NCT03746483)
- Testing
- MS1819, Porcine PERT
- Where
- 14 sites in United States, Poland
- Volunteers
- 41 people
- Sponsor
- Entero Therapeutics
Asthma, Atrial Fibrillation
The Living With a Long-Term Condition Study
Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs).
- Conditions
- Asthma, Atrial Fibrillation, Cancer, Cerebrovascular Disorders
- Trial name
- LTC (NCT06072287)
- Testing
- Living with LTC Questionnaire
- Where
- United Kingdom
- Volunteers
- 600 people
- Sponsor
- King's College London
Bronchiectasis
Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis
Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis.
- Trial name
- ANTEIPA (NCT06368804)
- Testing
- Antibiotic monotherapy treatment and follow-up, Antibiotic bitherapy treatment and follow-up
- Where
- 18 sites in France
- Volunteers
- 196 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Cystic Fibrosis
A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744)…
- Trial name
- NCT02565914
- Testing
- TEZ/IVA, IVA
- Where
- 154 sites in United States, Australia and 14 more
- Volunteers
- 1,131 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
PEP and OPEP Devices in Cystic Fibrosis
Cystic fibrosis (CF) is the most common severe autosomal recessive genetic disease in Caucasians. The CFTR (cystic fibrosis transmembrane regulator) gene, which encodes the chloride channel of the epithelial cell membrane, is…
- Trial name
- NCT05801952
- Testing
- Aerobika* OPEP, PARI O-PEP (Flutter), PARI PEP® S System
- Where
- Poland
- Volunteers
- 60 people
- Sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland