drugset / Trial / NCT04069312
Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial
Phase 3
Completed
1032 enrolled
Johns Hopkins University
Patient-Centered Outcomes Research Institute · collabUniversity of Illinois at Chicago · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-02-11
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 250 mg | — |
| Comparator | Azithromycin | Small molecule | 500 mg | — |
| Comparator | Roflumilast | Small molecule | 500 ug | — |