OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients with Chronic Obstructive Pulmonary Disease (BY217/M2-111)
Study identifier:BY217/M2-111
ClinicalTrials.gov identifier:NCT00076089
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Effect of roflumilast on exacerbation rate in patients with chronic obstructive pulmonary disease. A 52-week, multicenter, double-blind study with 500 mcg roflumilast once daily versus placebo.
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 3
Healthy volunteers
No
Study drug
Roflumilast
Sex
All
Actual Enrollment
1100
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Dec 2003
Primary Completion Date: 01 Dec 2005
Study Completion Date: 01 Dec 2005
Study design
Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
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Contacts
Investigators
Principal Investigator
AstraZeneca AstraZeneca
AstraZeneca
