Phase 3
Completed N=743
Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)
Source: ClinicalTrials.gov NCT00424268 ↗Enrolled (actual)
743
Serious AEs
5.8%
Results posted
May 2011
Primary outcomePrimary: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) — 65; -16 mL — p=<0.0001
Summary
The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. 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) |
65; -16 | <0.0001 sig |
| SECONDARY Post-bronchodilator FEV1 |
74; -7 | <0.0001 sig |
| SECONDARY COPD Exacerbation Rate (Moderate or Severe) |
0.262; 0.342 | 0.1957 |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score |
1.4; 0.9 | 0.0032 sig |
| SECONDARY Shortness of Breath Questionnaire (SOBQ) Total Score |
-3.4; -0.7 | 0.0051 sig |
Eligibility Criteria
Main Inclusion Criteria:
- History of COPD for at least 12 months prior to baseline visit and chronic productive cough for 3 months in each of the 2 years prior to baseline visit
- FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
- Treated with tiotropium for at least 3 months before enrollment
- At least 28 puffs of rescue medication during last week prior to randomization
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 (NCT00424268). 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.