Chronic obstructive pulmonary disease (COPD) is a highly prevalent disease, associated with significant economic burden, and for which available standard-of-care therapies show insufficient treatment effect on symptoms, lung function, exacerbations and long term progression of the disease. This study is designed to investigate the efficacy and safety profile of FDA approved medication being investigated for COPD over one year in patients with COPD who are in need of an additional treatment added to their current management.
INCLUSION CRITERIA:
Ø Participant must be ≥40 to ≤85 years of age, at the time of signing the informed consent.
Ø Type of participant and disease characteristics:
Ø Participants with a physician diagnosis of COPD who meet the following criteria at screening:
Ø • Current or former smokers with a smoking history of ≥10 pack-years - Current smokers are defined as those patients who are active smokers with ≥10 packyears of smoking (active smoking includes cigarettes, e-cigarettes, cigars, pipes, etc) - Former smokers are defined as those patients who were active smokers with ≥10 packyears of smoking (active smoking includes cigarettes, e-cigarettes, cigars, pipes, etc) and who have stopped smoking for at least 6 months prior to Visit 1
Ø • Moderate to severe COPD (post-bronchodilator FEV1/FVC ratio 30% and ≤70%).
Ø • Medical Research Council (MRC) Dyspnea Scale Grade ≥2.
Ø • Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
Ø • Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate* or ≥1 severe