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Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
Study identifier:BY217/M2-124
ClinicalTrials.gov identifier:NCT00297102
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Effect of roflumilast on exacerbation rate in patients with COPD. The AURA Study
Medical condition
Chronic obstructive pulmonary disease (COPD)
Phase
Phase 3
Healthy volunteers
No
Study drug
Roflumilast, Placebo
Sex
All
Actual Enrollment
1523
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Feb 2006
Primary Completion Date: 01 Jul 2008
Study Completion Date: 01 Sept 2008
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
Location
Altana Pharma/Nycomed Investigational Site
Fullerton, CA, United States, 92385
Location
Altana Pharma/Nycomed Investigational Site
Los Angeles, CA, United States, 90025
Location
Altana Pharma/Nycomed Investigational Site
Los Angeles, CA, United States, 90048
Location
Altana Pharma/Nycomed Investigational Site
Palmdale, CA, United States, 93551
Location
Altana Pharma/Nycomed Investigational Site
Rancho Mirage, CA, United States, 92270
Location
Altana Pharma/Nycomed Investigational Site
San Diego, CA, United States, 92120
Location
Altana Pharma/Nycomed Investigational Site
Bay Pines, FL, United States, 33708
Location
Altana Pharma/Nycomed Investigational Site
Miami, FL, United States, 33176
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Roflumilast 500 mcg, once daily, oral administration in the morning | Drug: Roflumilast 500 mcg, once daily, oral administration in the morning |
| Placebo Comparator: Placebo once daily | Drug: Placebo once daily |
Contacts
Contact
AstraZeneca Clinical Study Information Center
Investigators
Principal Investigator
AstraZeneca AstraZeneca
AstraZeneca
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