Clinical Study to Assess the Mode of Action of QBW251 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Summary
The purpose of this study was to determine whether potentiating the cystic fibrosis transmembrane conductance regulator (CFTR) with QBW251 in subjects with COPD would be efficacious with regards to reducing lung and systemic inflammation and bacterial colonization as potential drivers of airway obstruction, airway destruction, remodeling and exacerbations. Furthermore, this study provided supportive data to investigate the relationship of COPD phenotype and the response in small airway structure, function, mucus load and spirometry indices as well as in improvement of overall COPD symptoms and quality of life.
Timeline
- Start
- 2020-09-10
- Primary completion
- 2022-09-13
- Completion
- 2022-09-20
Outcome
Missed primary endpoint
Stopped (Business): “Sponsor decision”
registry analysis (superiority test); QBW251 300mg vs Placebo; p = 0.298; Least Squares mean -0.203 (80% CI -0.524 to 0.119); Mixed effects Model for Repeated Measure NCT04268823 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Icenticaftor | Small molecule | 300 mg | Oral |