The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor

NCT03085485 PHASE2 COMPLETED Results posted

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.

Details

Lead sponsor	University of Alabama at Birmingham
Phase	PHASE2
Status	COMPLETED
Enrolment	40
Start date	Thu Mar 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Sep 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Chronic Obstructive Pulmonary Disease
• Chronic Bronchitis

Interventions

• Ivacaftor 150 MG
• Placebo

Countries

United States