At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 12 enrolled
Drug / intervention
Ivacaftor +1 moredrug
Likely dose
Not stated in 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, Placebo Controlled Pilot 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 Early Phase 1 clinical trial evaluating Ivacaftor and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The study is a randomized, double-blind, placebo-controlled, multiple-dose, pilot study of orally-administered ivacaftor in subjects with chronic obstructive pulmonary disease. Subjects will be administered the study drug ivacaftor 150 mg (or placebo) twice daily (BID).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--
Timeline
Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartMay 2015
Primary CompletionOct 2015
Study CompletionNov 2015
TodayJul 2026
First PostedMay 12, 2014
Enrollment StartMay 1, 2015
Primary CompletionOct 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.1 years ago
Interventions
Ivacaftordrug
Placebodrug