PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)

Non-interventional, multi-country cohort study to assess the incidence of adverse cardiovascular and cerebrovascular events among patients with chronic obstructive pulmonary disease (COPD), exposed to inhaled fixed triple therapy BDP/FF/GB via DPI (drug of interest) or pMDI (comparator). The study will be conducted based on secondary health data collected (as per clinical practice) retrospectively from seven different European data sources in the following countries: United Kingdom, Germany, The Netherlands, Denmark, Sweden, Norway and Finland. Patients in the two exposure groups of this Post Authorisation Safety Study (PASS) will be followed for the study outcomes from the start of the exposure until the first occurrence of end of treatment, switch to the other study drug, end of the study period, or censoring. The pre-defined hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.