Status:
COMPLETED
Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)
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 compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant adminis...
Eligibility Criteria
Inclusion
- Main
- History of COPD for at least 12 months prior to baseline visit
- FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
- Main
Exclusion
- COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
933 Patients enrolled
Trial Details
Trial ID
NCT00313209
Start Date
April 1 2006
End Date
February 1 2008
Last Update
December 14 2016
Active Locations (134)
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1
Altana Pharma/Nycomed Investigational Site
Linz, Austria, 4020
2
Altana Pharma/Nycomed Investigational Site
Neusiedl/See, Austria, 7100
3
Altana Pharma/Nycomed Investigational Site
Perg, Austria, 4320
4
Altana Pharma/Nycomed Investigational Site
Salzburg, Austria, 5020