Clinical trials: Cystic Fibrosis (CF)
Cystic Fibrosis
A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1
The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic…
- Trial name
- NCT04059094
- Testing
- BI 1265162
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 52 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients
This is a prospective, longitudinal, 5-year study that will enroll participants from the existing Cystic Fibrosis Foundation (CFF) patient registry.
- Trial name
- AIR-CF5 (NCT01375036)
- Where
- 31 sites in United States
- Volunteers
- 510 people
- Sponsor
- Gilead Sciences
Bronchiectasis
Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis
The primary objective of this study is to assess the safety and tolerability of 28 day oral administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE).
- Trial name
- NCT01818544
- Testing
- BAY85-8501
- Where
- 33 sites in France, Germany and 3 more
- Volunteers
- 94 people
- Sponsor
- Bayer
Cystic Fibrosis
Safety Study of Ivacaftor in Subjects With Cystic Fibrosis
The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance…
- Trial name
- NCT00457821
- Testing
- Ivacaftor 25 mg/75 mg, Ivacaftor 75 mg/150 mg, Ivacaftor 150 mg or 250 mg
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 39 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Pulmonary Cystic Fibrosis
Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )
Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree.
- Trial name
- NCT04095078
- Testing
- SIMEOX
- Where
- 5 sites in France
- Volunteers
- 56 people
- Sponsor
- Physio-Assist
Bronchiectasis
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3…
- Trial name
- AIR-BX2 (NCT01314716)
- Testing
- AZLI
- Where
- 85 sites in United States, Australia and 8 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
- Trial name
- NCT05033080
- Testing
- VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA
- Where
- 139 sites in United States, Australia and 10 more
- Volunteers
- 435 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation
The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR…
- Trial name
- NCT01946412
- Testing
- Ivacaftor
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 33 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Aspergillosis, Cystic Fibrosis
The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis
This study tests the effects of an experimental drug PC945 in people with cystic fibrosis whose lungs are infected by the fungus Aspergillus fumigatus.
- Trial name
- NCT03870841
- Testing
- PC945
- Where
- 2 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- Pulmocide Ltd
Cystic Fibrosis
A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)
This study was evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function…
- Trial name
- NCT04599465
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 41 sites in Australia, Belgium and 5 more
- Volunteers
- 69 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic…
- Trial name
- NCT01225211
- Testing
- Lumacaftor, Ivacaftor
- Where
- 55 sites in United States, Australia and 5 more
- Volunteers
- 312 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis, Pancreatic Insufficiency
Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI
The purpose of this phase II research study is to evaluate the effectiveness of the next generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for children and adolescents with Cystic Fibrosis (CF)…
- Trial name
- NCT00406536
- Testing
- Lym-X-Sorb powder
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Avanti Polar Lipids, Inc.
Cystic Fibrosis
A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)
The purpose of this study is to evaluate the safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in participants with CF who are 12 years of age or older.
- Trial name
- NCT05111145
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 24 sites in Australia, Belgium and 3 more
- Volunteers
- 86 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis (CF)
Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.
The purpose of Parts D and E of this Phase 1 study are to evaluate the safety, tolerability, and pharmacokinetics of multiple dose combinations of SION-451 and complementary modulators SION-2222 and SION-109 in healthy…
- Trial name
- NCT07035990
- Testing
- SION-451, SION-2222, SION-109
- Where
- 2 sites in Australia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Sionna Therapeutics Inc.
Cystic Fibrosis, Bronchiectasis
Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis
This is a single center, open label, Phase IIa, multiple-ascending dose study in which subjects with mild to moderate Cystic Fibrosis and non CF bronchiectasis (n≤12) will be enrolled.
- Trial name
- NCT03903913
- Testing
- S-1226
- Where
- 3 sites in Canada
- Volunteers
- 12 people
- Sponsor
- SolAeroMed Inc.
Cystic Fibrosis
A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients with Cystic Fibrosis
A double-blind, randomised study of OligoG DPI compared to placebo DPI, both on top of standard-of-care, to assess safety, efficacy and tolerability. Adult patients with Cystic Fibrosis will be included in the study.
- Trial name
- NCT03822455
- Testing
- OligoG DPI
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- AlgiPharma AS
Bronchiectasis
Inhalation Flow Rate-study
Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.
- Trial name
- NCT02563197
- Testing
- T-326 Inhaler
- Where
- 10 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Bayer
Cystic Fibrosis
A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)
Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic…
- Trial name
- NCT03150719
- Testing
- Tezacaftor/Ivacaftor, Ivacaftor
- Where
- 53 sites in United States, France and 1 more
- Volunteers
- 98 people
- Sponsor
- Vertex Pharmaceuticals Incorporated