drugset / Trial / NCT04066751
The Multicenter Topic Trial
Phase 2
Withdrawn
University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabVertex Pharmaceuticals Incorporated · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this protocol is to test the safety, pharmacokinetics, and pharmacodynamics of the Cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, ivacaftor in patients with chronic obstructive pulmonary disease (COPD) and chronic bronchitis. This project will investigate the hypothesis that ivacaftor can augment CFTR activity in individuals with COPD who exhibit chronic bronchitis, resulting in meaningful improvements in epithelial function and respiratory health. The study is a multicenter, randomized, double-blind, placebo-controlled, stratified study of orally-administered ivacaftor.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2024-10-31
- Completion
- 2024-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ivacaftor | Other / unclassified | 150 mg | Oral |