Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00297102 · ClinicalTrials.gov registry record · Phase 3
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,523
- Enrollment target
NCT00297102: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00297102 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 1,523 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00297102, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,523 participants
- Enrollment target
Study Summary
The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast. For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).
Primary Outcome
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
Interventions
- DRUG Placebo
- DRUG Roflumilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,523 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
What the finished NCT00297102 record still lists
NCT00297102 is an interventional study that assigns participants to a tested intervention. Its 1,523 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 (97% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00297102 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00297102 about?
NCT00297102 is a clinical study titled "Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)". The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks...
What is the current status of trial NCT00297102?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,523 participants. The study started on 2006-02. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00297102?
The interventions under investigation include: Placebo (DRUG), Roflumilast (DRUG).
Who is sponsoring clinical trial NCT00297102?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00297102's enrollment target sits among peer trials
1,523 156th of 2000 higher than 1,845 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06876714 · 1,524 participants · Phase 3
ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab
- NCT06257082 · 1,526 participants · NA
Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities
- NCT07232017 · 1,520 participants
Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic
- NCT06623097 · 1,528 participants · NA
Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia