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NCT04069312 · ClinicalTrials.gov registry record · Phase 3
Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial
A Phase 3 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,032
- Enrollment target
NCT04069312: Completed Phase 3 study, sponsored by Johns Hopkins University.
NCT04069312 is a Phase 3 study that has completed, run by Johns Hopkins University. The registered enrollment target is 1,032 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04069312, a Phase 3 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,032 participants
- Enrollment target
Study Summary
A multi-center, randomized, 72-month, parallel- group, non-inferiority, phase III study to compare the effectiveness of roflumilast (Daliresp, 500 mcg quaque die (QD) or alternate regimen) therapy versus azithromycin (250 mg QD, 500 mg QD three times per week, or alternate regimen) to prevent hospitalization or death in a patients at high risk for COPD exacerbations.
Interventions
- DRUG Roflumilast
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,032 participants |
| Start Date | 2020-02-11 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04069312
The ClinicalTrials.gov registry entry for NCT04069312 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,032 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Roflumilast is the first listed.
NCT04069312 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04069312 about?
NCT04069312 is a clinical study titled "Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial". A multi-center, randomized, 72-month, parallel- group, non-inferiority, phase III study to compare the effectiveness of roflumilast (Daliresp, 500 mcg quaque die (QD) or alternate regimen) therapy versus azithromycin (250 mg QD, 500 mg QD three times per week, or alternate regimen) to prevent hospit...
What is the current status of trial NCT04069312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,032 participants. The study started on 2020-02-11. Estimated completion is 2026-03-01.
What interventions are being tested in trial NCT04069312?
The interventions under investigation include: Roflumilast (DRUG), Azithromycin (DRUG).
Who is sponsoring clinical trial NCT04069312?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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