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

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