Study identifier:BY217/M2-128
ClinicalTrials.gov identifier:NCT00424268
EudraCT identifier:2006-004508-37
CTIS identifier:N/A
Effect of roflumilast in COPD patients treated with tiotropium. A 24-week, double-blind study with 500 µg roflumilast once daily versus placebo. The HELIOS Study
Chronic Obstructive Pulmonary Disease
Phase 3
No
Roflumilast, Placebo
All
743
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Roflumilast Roflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled | Drug: Roflumilast 500 µg, once daily, oral administration in the morning |
Placebo Comparator: Placebo Placebo underlying medication: tiotropium 18 µg, once daily, inhaled | Drug: Placebo once daily |