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NCT02135432 · ClinicalTrials.gov registry record · Early Phase 1
TOPIC Trial for COPD
A Early Phase 1 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT02135432: Completed Early Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT02135432 is a Early Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02135432, a Early Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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).
Primary Outcome
sweat analysis is measured by performing a sweat test in each participant. The primary analysis will compare the within group change in sweat chloride before (day 1) and after (day 14) ivacaftor or placebo administration and will be used to test the null hypothesis of no change in sweat chloride using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.
Interventions
- DRUG Placebo
- DRUG Ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-05 |
| Est. Completion | 2015-11 |
| Phase | Early Phase 1 |
What the finished NCT02135432 record still lists
NCT02135432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02135432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02135432 about?
NCT02135432 is a clinical study titled "TOPIC Trial for COPD". 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).
What is the current status of trial NCT02135432?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2015-05. Estimated completion is 2015-11.
What interventions are being tested in trial NCT02135432?
The interventions under investigation include: Placebo (DRUG), Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT02135432?
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 NCT02135432's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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