Effect of aclidinium bromide/formoterol fumarate fixed-dose combination (FDC) on exacerbations in moderate-to-severe COPD: Pooled analysis of two studies

Background Twice-daily (BID) aclidinium/formoterol 400/12 µg FDC is in development for treatment of COPD. Methods Data were pooled for two 24-week, randomised, double-blind Phase 3 studies of aclidinium/formoterol FDC in patients with moderate-to-severe COPD (ACLIFORM and AUGMENT). Patients received FDC (400/6 µg or 400/12 µg), aclidinium 400 µg, formoterol 12 µg or placebo (all BID via Genuair® inhaler). Prior exacerbation was not an inclusion criterion. Exacerbations (reported and unreported) were assessed by healthcare resource utilisation (HCRU; symptom increase on ≥2 consecutive days requiring treatment change) and the EXAcerbations of Chronic pulmonary disease Tool (EXACT; increase ≥9 points for ≥3 days or ≥12 points for ≥2 days). Results Data were analysed for 3398 patients (safety population; means: age 63.5 years, 60.5% male, GOLD stage II, 58.6%; III, 40.8%). Treatment with FDC 400/12 µg significantly reduced moderate-severe HCRU (29%; p<0.05) and EXACT (22%; p<0.01) exacerbation rates vs placebo. Time to first exacerbation was significantly delayed for FDC 400/12 µg vs placebo (hazard ratio 0.70 [moderate-severe HCRU] and 0.79 [EXACT]; both p<0.05). Conclusion In a study population where prior exacerbation was not an inclusion criterion, aclidinium/formoterol 400/12 µg FDC reduced the rate of COPD exacerbations defined by HCRU or EXACT. ![Figure][1] [1]: pending:yes