Status:
COMPLETED
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administ...
Eligibility Criteria
Inclusion
- Main
- COPD patients having at least one exacerbation within last year
- FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- FEV1 (post-bronchodilator) ≤ 50% of predicted
- Main
Exclusion
- COPD exacerbation not resolved at first baseline visit
- Diagnosis of asthma and/or other relevant lung disease
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
1523 Patients enrolled
Trial Details
Trial ID
NCT00297102
Start Date
February 1 2006
End Date
September 1 2008
Last Update
January 16 2017
Active Locations (179)
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1
Altana Pharma/Nycomed Investigational Site
Fullerton, California, United States, 92385
2
Altana Pharma/Nycomed Investigational Site
Los Angeles, California, United States, 90025
3
Altana Pharma/Nycomed Investigational Site
Los Angeles, California, United States, 90048
4
Altana Pharma/Nycomed Investigational Site
Palmdale, California, United States, 93551