The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor
(VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis,
and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot,
randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40
subjects with COPD will be randomized.
Phase:
Phase 2
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) Vertex Pharmaceuticals Incorporated