Study identifier:RO-2455-405-RD
ClinicalTrials.gov identifier:NCT01473758
EudraCT identifier:2011-002905-31
CTIS identifier:N/A
Effect of Roflumilast 500 μg Tablets Once Daily at Acute COPD Exacerbations Treated with Standard Therapy of Oral Steroids and Antibiotics. A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial
Chronic Obstructive Pulmonary Disease with (Acute) Exacerbation
Phase 2
No
Roflumilast, Placebo
All
81
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Roflumilast added on to standard therapy for acute COPD exacerbations | Drug: Roflumilast 500 µg tablet, od, oral administration in the morning after breakfast |
Placebo Comparator: Placebo added on to standard therapy for acute COPD exacerbations | Drug: Placebo tablet, od, oral administration in the morning after breakfast |