Early use of Single-Inhaler Triple Therapy and the effect on 30-day readmission

Trial description: Chronic obstructive pulmonary disease (COPD) represents a significant cause of global morbidity and mortality, with a substantial economic impact. Episodes of acute worsening of respiratory symptoms, known as COPD exacerbations, are a key driver of clinical and economic burden and hospitalizations as they are associated with high costs, readmission rates, and risk of death. TRELEGY ELLIPTA is a multi-dose inhaler containing a fixed-dose combination of fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI). It was recently approved by the United States Food and Drug Administration (US FDA) as the first single-inhaler triple therapy for the long-term maintenance treatment of COPD among participants who are on a fixed-dose combination of FF/VI, in whom additional bronchodilation is required, or for participants who are already receiving UMEC and a fixed-dose combination of FF/VI. Recently, the approval for TRELEGY ELLIPTA was expanded to participants with a history of exacerbations. There is limited evidence to inform the optimal timing of triple therapy initiation. The current study aims to evaluate the impact of prompt versus delayed FF/UMEC/VI initiation on rates of exacerbations and readmission, as well as medical costs among COPD participants in a large commercially insured population in the US. Prompt initiators are participants with COPD who initiate FF/UMEC/VI soon after the date of the COPD-related exacerbation discharge (within 30 days), whereas delayed initiators are those who initiate FF/UMEC/VI later after the date of the discharge (between 31–180 days). TRELEGY ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.