Phase 3
Completed N=1,523
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
Source: ClinicalTrials.gov NCT00297102 ↗Enrolled (actual)
1,523
Serious AEs
19.5%
Results posted
May 2011
Primary outcomePrimary: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) — 46; 8 mL — p=0.0003
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) |
46; 8 | 0.0003 sig |
| PRIMARY COPD Exacerbation Rate (Moderate or Severe) |
1.077; 1.266 | 0.0278 sig |
| SECONDARY Post-bronchodilator FEV1 [L] |
57; 8 | <0.0001 sig |
| SECONDARY Time to Mortality Due to Any Reason |
213.8; 207.5 | 0.9212 |
| SECONDARY Natural Log-transformed C-reactive Protein (CRP) |
1.0475; 1.1003 | 0.4089 |
| SECONDARY Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period |
0.658; 0.426 | 0.0356 sig |
Eligibility Criteria
Main Inclusion Criteria:
- COPD patients having at least one exacerbation within last year
- FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- FEV1 (post-bronchodilator) ≤ 50% of predicted
Main Exclusion Criteria:
- COPD exacerbation not resolved at first baseline visit
- Diagnosis of asthma and/or other relevant lung disease
Data sourced from ClinicalTrials.gov (NCT00297102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.