Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127) (EOS)
Chronic Obstructive Pulmonary Disease (COPD)
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Roflumilast, Salmeterol, COPD, Chronic obstructive pulmonary disease
Eligibility Criteria
Main Inclusion Criteria: 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 Criteria: COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Roflumilast
Placebo
Roflumilast 500 µg underlying medication: salmeterol 50 μg, twice daily, inhaled
Placebo underlying medication: salmeterol 50 μg, twice daily, inhaled