Clinical Trials

Inclusion Criteria:

1. Male or female patients at least 40 years of age
2. History of COPD (according to 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