Comparative Effectiveness of Early versus Late Start with Umeclidinium/vilanterol

Trial description: UMEC/VI is a combination medication with a long-acting muscarinic antagonist with a long acting beta-2-agonist (LAMA/LABA) for the treatment of chronic obstructive pulmonary disease (COPD). UMEC/VI has shown improvement in lung function and quality of life in subjects with COPD. However, it is unknown whether earlier use of UMEC/VI results in better outcomes and overall reduction in long-term COPD-related health care utilization. This study aims to compare COPD-related health care costs between early initiators of treatment with UMEC/VI versus subjects with later or delayed initiation of UMEC/VI. Thus, this analysis is designed to examine if earlier treatment initiation with UMEC/VI will have lower COPD-related health care costs compared to subjects who initiate UMEC/VI later. This retrospective cohort study will include commercial and Medicare Advantage with Part D (MAPD) subjects treated with UMEC/VI between 28 April 2014 and 31 July 2016 (the subject identification [ID] period). The study will use medical data, pharmacy data, and enrollment information in the Optum Research Database (ORD). Subject will be assigned to cohorts based on whether they initiate UMEC/VI within 30 days of the index date (early initiation cohort) or at greater than 30 days following the index date (late initiation cohort). All subjects will be required to be continuously enrolled in the health plan for a minimum of one year for measurement of Baseline characteristics in Baseline period (six months prior to the index date) and outcomes in follow-up period (six months following the index date).