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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 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03085485
The ClinicalTrials.gov registry entry for NCT03085485 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03085485 reports 0 study locations.
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.
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