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NCT03085485 · ClinicalTrials.gov registry record · Phase 2
The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT03085485: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT03085485 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03085485, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Safety of ivacaftor will be determined by number of participants with adverse events (including serious adverse events).
Interventions
- DRUG Placebo
- DRUG Ivacaftor 150 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-03-16 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 2 |
What the finished NCT03085485 record still lists
NCT03085485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03085485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03085485 about?
NCT03085485 is a clinical study titled "The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor". 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, activ...
What is the current status of trial NCT03085485?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-03-16. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT03085485?
The interventions under investigation include: Placebo (DRUG), Ivacaftor 150 MG (DRUG).
Who is sponsoring clinical trial NCT03085485?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03085485's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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