Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination
 (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
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

 Exclusion Criteria:

 -  1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with
 antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1)
 (ie, patients must be clinically stable)

 -  2. Known alpha-1-antitrypsin deficiency

 -  3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of
 childhood asthma is not exclusionary.)

 -  4. Body mass index (BMI) ≥ 45 kg/m2

 -  5. Patients with a history (within 5 years) or current diagnosis of cancer other than
 basal or squamous cell skin cancer