Status:
COMPLETED
Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomit...
Eligibility Criteria
Inclusion
- Main
- History of COPD for at least 12 months prior to baseline visit and chronic productive cough for 3 months in each of the 2 years prior to baseline visit
- FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
- Treated with tiotropium for at least 3 months before enrollment
- At least 28 puffs of rescue medication during last week prior to randomization
- 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 :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
743 Patients enrolled
Trial Details
Trial ID
NCT00424268
Start Date
January 1 2007
End Date
July 1 2008
Last Update
December 5 2016
Active Locations (103)
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1
Altana Pharma/Nycomed Investigational Site
Feldbach, Austria, 8330
2
Altana Pharma/Nycomed Investigational Site
Gänserndorf, Austria, 2230
3
Altana Pharma/Nycomed Investigational Site
Hallein, Austria, 5400
4
Altana Pharma/Nycomed Investigational Site
Linz, Austria, 4040