Post-authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients Using Inhaled UMEC/VI Combination or Inhaled UMEC versus Tiotropium (Study 201038)

Trial description: It is a multinational, non-randomised, prospective observational cohort study of COPD subjects which aims to collect data reflecting the ‘real-world’ experience of COPD subjects treated with either umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; long-acting beta2 agonist [LABA]) combination product or UMEC in the post approval setting. The purpose of the study is to expand understanding of the potential cardiovascular (CV) and cerebrovascular risks of myocardial infarction (MI), stroke and new onset or acute worsening/decompensation heart failure of UMEC/VI and UMEC as compared to tiotropium (a drug having well established safety and efficacy profile). It is designed to demonstrate non-inferiority for each of the three individual CV and cerebrovascular outcomes of MI, stroke and new onset, or acute worsening/decompensation heart failure. The analysis will compare new users of UMEC/VI and UMEC with new users of tiotropium. Analyses will be based on the time to the first event of stroke, MI and heart failure individually and non-inferiority will be considered to be demonstrated if the upper bound of the 95% confidence interval around the hazard ratio is 2.0 or less. If the lower bound is greater than 1.0, non-inferiority will not be assumed. The study will enrol an estimated 7,800 subjects from a total of approximately 700 centres throughout selected European (EU) and non EU countries. This is an event driven study, required to observe at least 98 events for each of MI, stroke and heart failure in each pair of treatments. Subjects will be enrolled in the study by primary care physicians and pulmonologists. The decision to initiate use of UMEC/VI, UMEC, or tiotropium is to be made independently by the participant and their physician. Individual patients will be observed over at least a 24 month time frame, or until withdrawal of consent, loss to follow-up, or death. During this period, data will be collected at routine and unscheduled visits by their physician as they occur. Routine visits are expected to be at least twice yearly as part of normal care.