Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population

Background and objective Aclidinium bromide ('aclidinium') is a novel, inhaled long-acting muscarinic antagonist. Therapeutic effects of aclidinium on chronic obstructive pulmonary disease (COPD) have been demonstrated in Caucasian populations in several clinical trials. This was a randomized, double-blind, multi-centre phase-3 clinical trial to evaluate the efficacy and safety of aclidinium in a Korean population. Methods A total of 263 Korean patients with moderate-to-severe COPD were randomized to receive aclidinium (400-μg, bd) (Genuai) or placebo via a dry-powder inhaler. The primary end point was change in trough forced expiratory volume in one second (FEV₁) at 12 weeks. Other lung function measurements, COPD exacerbation, health status (St George's Respiratory Questionnaire (SGRQ), dyspnoea (Transition Dyspnea Index (TDI) and safety were assessed throughout the study period. Results A significant improvement in trough FEV₁ from baseline was shown with aclidinium compared with the placebo (0.126-L, P-<-0.0001). Significant improvements were also demonstrated in peak FEV₁ (0.190-L, P-<-0.0001), SGRQ and TDI. Furthermore, aclidinium significantly reduced the prevalence of exacerbations (aclidinium, 5.4%; placebo, 15.6%, P-<-0.05), and the duration of exacerbations was shorter compared with placebo (rate ratio: 0.27; P-<-0.05). Aclidinium (400-μg) was well tolerated and the prevalence of adverse events was comparable with the placebo. Conclusions Inhaled aclidinium (400-μg) was shown to be safe and efficacious in Korean patients with moderate-to-severe COPD. Clinical trial registration: NCT01636401 at Clinicaltrials.gov This study demonstrated a favourable safety and efficacy profile of aclidinium bromide in Korean COPD patients that was similar to what was observed in Caucasian populations, suggesting no clinically significant ethnic difference.