ACCORD COPD I: Twice-daily aclidinium bromide improves quality of life and dyspnea in COPD patients

Introduction: Aclidinium bromide is a long-acting muscarinic antagonist in development for treatment of COPD. In this Phase III study, the effects of twice-daily aclidinium on health outcomes were assessed. Methods: In this 12-week, double-blind study, moderate to severe COPD patients were randomised to receive aclidinium 200 μg, 400 μg, or placebo BID. Health outcomes were assessed monthly via SGRQ and TDI. Results: Of the 561 patients randomised, 467 (83%) completed the study. At baseline, the mean (SD) prebronchodilator FEV1 and percent predicted were 1.36 (0.54) L and 47.2 (14.1)%, respectively. 1 Baseline mean (SD) SGRQ total score and BDI focal score were 46.5 (17.1) and 6.4 (2.1), respectively. Adjusted mean differences vs placebo in change from baseline in SGRQ total score at Week 12 were -2.7 (p=0.01) and -2.5 (p=0.02) for aclidinium 200 μg and 400 μg, respectively. At all time points, statistically greater percentages of aclidinium patients achieved clinically significant improvements in SGRQ vs placebo (≥4 points; p<0.05 for all except Week 12, 400 μg group). Both aclidinium doses provided significant improvements vs placebo in TDI focal score (p<0.05, range 0.6 to 1.4) throughout the study; with the exception of aclidinium 200 μg at Week 8 (p=0.06). Significantly greater percentages of patients achieved clinically meaningful improvements in TDI (≥1 unit) with both aclidinium doses at all time points vs placebo (p<0.05). Conclusions: In this 12-week study, aclidinium 200 μg and 400 μg BID significantly improved quality of life and reduced dyspnea for patients with moderate to severe COPD.