Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

Inclusion Criteria

• - 1. Male or female patients at least 40 years of age
• - 2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
• - 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1)
• - 4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
• - 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
• - 6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
• - 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years