Impact of initiating maintenance treatment (MT) promptly post-chronic obstructive pulmonary disease (COPD) exacerbation in a managed care setting

Trial description: Additional evidence is needed on whether the timing of initiation of maintenance treatment (MT) influences the risk of future exacerbations, especially in a real-world setting. The following study evaluates the impact of initiating MT earlier versus later (delayed) following a chronic obstructive pulmonary disease (COPD)-related exacerbation on outcomes of COPD-related costs and future exacerbations in subjects with COPD. MT is defined as treatment with long-acting beta agonist (LABA), long-acting antimuscarinic agents (LAMA), combination drug product of fluticasone propionate 250 micrograms (mcg) plus salmeterol 50 mcg (FSC) and budesonide 160 mcg plus formoterol fumarate dihydrate 4.5 mcg (BFC), roflumilast and methylxanthines. The primary objective of this study is to examine COPD-related costs (total, medical, prescription) for subjects initiating MT promptly (within 30 days) versus delayed (31-180 days) following an exacerbation. The null hypothesis is that no difference will be observed.The secondary objectives are to compare the impact of MT when initiated promptly (≤ 30 days) versus delayed (31-180 days) on components of COPD-related medical costs and to compare the impact of MT when initiated promptly (≤ 30 days) versus delayed (31-180 days) on rate and number of future COPD-related exacerbations.The study design is a retrospective observational cohort. The data source is the Truven Health MarketScan Commercial Claims and Encounters Database (Commercial) and Medicare Supplemental and Coordination of Benefits Database (Medicare) will be used for this study.