Phase 3
Completed N=933
Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)
Source: ClinicalTrials.gov NCT00313209 ↗Enrolled (actual)
933
Serious AEs
8.4%
Results posted
May 2011
Primary outcomePrimary: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) — 39; -10 mL — p=<0.0001
Summary
The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) |
39; -10 | <0.0001 sig |
| SECONDARY Post-bronchodilator FEV1 |
68; 8 | <0.0001 sig |
| SECONDARY COPD Exacerbation Rate (Mild, Moderate or Severe) |
1.9; 2.4 | 0.1408 |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score |
1.2; 1.1 | 0.4654 |
| SECONDARY Shortness of Breath Questionnaire (SOBQ) Total Score |
-0.6; -1.1 | 0.5457 |
Eligibility Criteria
Main Inclusion Criteria:
- History of COPD for at least 12 months prior to baseline visit
- FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
Main Exclusion Criteria:
- COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
Data sourced from ClinicalTrials.gov (NCT00313209). 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.