At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
Ivacaftor 150 MG +1 moredrug
Likely dose
Ivacaftor 150 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Phase 2, Placebo Controlled Study to Determine the Safety and Efficacy of Ivacaftor (VX-770) for the Treatment of Chronic Obstructive Pulmonary Disease (The Topic Trial)
In Brief
A Phase 2 clinical trial evaluating Ivacaftor 150 MG and Placebo for Chronic Obstructive Pulmonary Disease and Chronic Bronchitis. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
First PostedMar 2017
Primary CompletionSep 2022
TodayJul 2026
First PostedMar 21, 2017
Enrollment StartMar 16, 2017
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.3 years ago
Interventions
Ivacaftor 150 MGdrug
Ivacaftor is a CFTR potentiator
Placebodrug
placebo pills