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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, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher). 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.
Primary Outcome
Composite time-to-event outcome defined as time from randomization to the first occurrence of all-cause hospitalization or all-cause death.
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 |
What the finished NCT04069312 record still lists
NCT04069312 is an interventional study that assigns participants to a tested intervention. Its 1,032 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 2 interventions - of which Roflumilast is the first listed.
NCT04069312 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04069312's enrollment target sits among peer trials
1,032 288th of 2000 higher than 1,713 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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