Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Subjects With Bronchiectasis
NCT04396366 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-09-26
Summary
The purpose of this study is to determine whether potentiating the cystic fibrosis transmembrane conductance regulator (CFTR) with QBW251 in patients with bronchiectasis will demonstrate clinical safety and efficacy related to improved mucociliary clearance with reduced bacterial colonization as potential drivers of airway obstruction, reduced airway inflammation, exacerbations and mucus load, improved lung function, clinical symptoms and quality of life to support further development in bronchiectasis.
Conditions
Interventions
- DRUG
-
QBW251
QBW251, 300 mg, oral use, one capsule, twice daily.
- DRUG
-
Matching placebo, 300 mg, oral use, one capsule, twice daily.
Sponsors & Collaborators
-
Innovative Medicines Initiative
collaborator OTHER - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-02
- Primary Completion
- 2023-06-15
- Completion
- 2023-06-21
Countries
- China
- Germany
- Spain
- United Kingdom
Study Locations
More Related Trials
-
BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects
NCT02976519 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients
NCT00274313 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation
NCT01262352 ·Status: COMPLETED ·Phase: PHASE2
-
Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis
NCT00671736 ·Status: COMPLETED ·Phase: PHASE2
-
CF Bronchodilation
NCT03522831 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation
NCT03068312 ·Status: COMPLETED ·Phase: PHASE3
-
Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis
NCT05740618 ·Status: COMPLETED ·Phase: PHASE4
-
Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus
NCT05101915 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)
NCT05668741 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis
NCT03870841 ·Status: TERMINATED ·Phase: PHASE2
-
Inhaled Therapy Adherence and Outcomes to Kaftrio in Cystic Fibrosis
NCT05519020 ·Status: COMPLETED
-
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
NCT00677365 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients
NCT02532764 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations
NCT03000348 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in Adult and Pediatric Patients With Cystic Fibrosis
NCT00034515 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis
NCT00503490 ·Status: COMPLETED ·Phase: PHASE1
-
"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"
NCT00840333 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF
NCT03748199 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis
NCT00581997 ·Status: TERMINATED ·Phase: PHASE2
-
Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease
NCT00056147 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease
NCT00934362 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis
NCT02141958 ·Status: COMPLETED ·Phase: PHASE1
-
A Two-Part Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeat Doses of Inhaled ETD001 in People With Cystic Fibrosis
NCT06478706 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
NCT01347190 ·Status: COMPLETED ·Phase: PHASE1
-
VX-770 for the Treatment of Chronic Bronchitis
NCT03251911 ·Status: WITHDRAWN ·Phase: PHASE4