Clinically important deteriorations in COPD as a measure of response to dual and mono bronchodilator therapy with and without inhaled corticosteroids

Abstract

Background: Bronchodilator therapy with long-acting muscarinic antagonists (LAMAs), β 2 -agonists (LABAs) and inhaled corticosteroids (ICS) is commonly used to improve outcomes in COPD. We examined clinically important deteriorations (CID) to quantify response to ICS/LABA+LAMA or LAMA/LABA. Methods: Two post hoc pooled analyses were performed on data from four 12-wk studies of umeclidinium 62.5mcg (UMEC)+ICS/LABA vs placebo (PBO)+ICS/LABA, and three 24-wk studies of umeclidinium/vilanterol 62.5/25mcg (UMEC/VI) vs tiotropium 18mcg (TIO). The analyses examined if dual bronchodilation ±ICS delayed onset of CID vs ICS/LABA or LAMA. CID was defined as: decrease from baseline ≥100mL in trough FEV 1 , decline in health-related quality of life (≥4 units St George9s Respiratory Questionnaire total score), or moderate/severe COPD exacerbation; CID was sustained if lasting ≥2 visits or 50% of time thereafter. Results: In the 12-wk studies, 377/819 (46%) UMEC+ICS/LABA and 554/818 (68%) PBO+ICS/LABA patients had ≥1 CID (hazard ratio [HR]: 0.52, 95% confidence interval [CI]: 0.45–0.59; p Conclusion: CID is a useful endpoint to differentiate responses to treatment with dual and mono bronchodilator therapy ±ICS in COPD. Funded by GSK (NCT: 01957163, 02119286, 01772134, 01772147, 01316900, 01316913, 01777334).