Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial
Public ClinicalTrials.gov record NCT04069312. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04069312
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,032 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 11, 2020 (Actual)
- Primary completion
- Mar 1, 2026 (Actual)
- Completion
- Mar 1, 2026 (Actual)
- Last update posted
- Aug 21, 2026
2020 – 2026
United States locations
- U.S. sites
- 28
- U.S. states
- 19
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | — |
| University of Arizona | Tucson | Arizona | 85734 | — |
| University of California, Davis Health | Sacramento | California | 95817 | — |
| Northwestern | Chicago | Illinois | 60611 | — |
| University of Illinois Chicago | Chicago | Illinois | 60612 | — |
| NorthShore Hospital | Glenview | Illinois | 60026 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas | Kansas City | Kansas | 66160 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Johns Hopkins University | Baltimore | Maryland | 21224 | — |
| Baystate Health | Springfield | Massachusetts | 01199 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| University of Missouri, Kansas City | Kansas City | Missouri | 64108 | — |
| Lenox Hill/Northern Westchester Hospital (Northwell Health) | Mount Kisco | New York | 10549 | — |
| Mount Sinai | New York | New York | 10029 | — |
| University of North Carolina, School of Medicine | Chapel Hill | North Carolina | 27599 | — |
| Duke | Durham | North Carolina | 27705 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Kaiser Permanente | Portland | Oregon | 97227 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Baylor Scott & White (BSW) Health-North | Dallas | Texas | 75246 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| University of Vermont | Burlington | Vermont | 05401 | — |
| Providence Health and Services | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04069312, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04069312 live on ClinicalTrials.gov.