WEUSKOP6679:Post-authorization safety Electronic Medical Records database retrospective cohort study of new users of inhaled UMEC/VI or new users of inhaled UMEC in the primary care setting: UK EMR distributed network study

Trial description: A post-authorization safety Electronic Medical Records (EMR) database retrospective cohort study of new users of inhaled umeclidinium/vilanterol (UMEC/VI) or new users of inhaled umeclidinium (UMEC) in the primary care setting. This study primarily aims to collect data reflecting the real-world experience with UMEC/VI and UMEC in the post-approval setting (period of up to 24 months from the start of UMEC/VI and UMEC availability in the United Kingdom). The study will use a retrospective longitudinal non-interventional observational study design to identify patients based on a new prescription (index prescription date) for UMEC/VI, UMEC, or other long acting bronchodilator (LABD). These patients will be followed-up from their index prescription date until censoring at death, leaving practice, or end of follow-up on June 30, 2017.The study has the following aims:Objective 1: In new users of UMEC/VI, UMEC, or other LABD report the proportion of patients with possible off-label use and characterize them, using information available prior to and at the time of index prescription initiation, in respect to patient demographics, co-morbidity, disease burden, and COPD or asthma medication use.Objective 2: In new users of UMEC/VI or UMEC, quantify incidence of major cardiovascular and cerebrovascular events, mortality, pneumonia, and exacerbations of COPD during follow-up.Objective 3: In new users of UMEC/VI or UMEC with 12 or more months of follow-up following initiation, describe treatment patterns and adherence including Medication Possession Ratio (MPR) and Proportion of Days Covered (PDC) during follow-up.