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Efficacy and safety of aclidinium bromide in patients with COPD : A phase 3 randomized clinical trial in a K orean population
Author(s) -
Lee Sang Haak,
Lee Jongmin,
Yoo Kwang Ha,
Uh SooTaek,
Park Myung Jae,
Lee Sang Yeub,
Kim Jae Yeol,
Kim Deog Kyeom,
Kim Seung Joon,
Lee Kwan Ho,
Yoo ChulGyu
Publication year - 2015
Publication title -
respirology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.857
H-Index - 85
eISSN - 1440-1843
pISSN - 1323-7799
DOI - 10.1111/resp.12641
Subject(s) - medicine , copd , placebo , dry powder inhaler , exacerbation , adverse effect , population , randomized controlled trial , clinical endpoint , muscarinic antagonist , inhaler , anesthesia , antagonist , asthma , alternative medicine , receptor , environmental health , pathology
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 C aucasian 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 K orean population. Methods A total of 263 K orean 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 ( FEV 1 ) at 12 weeks. Other lung function measurements, COPD exacerbation, health status ( S t G eorge's R espiratory Q uestionnaire ( SGRQ ), dyspnoea ( T ransition D yspnea I ndex ( TDI ) and safety were assessed throughout the study period. Results A significant improvement in trough FEV 1 from baseline was shown with aclidinium compared with the placebo (0.126 L , P < 0.0001). Significant improvements were also demonstrated in peak FEV 1 (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 K orean patients with moderate‐to‐severe COPD . Clinical trial registration: NCT01636401 at Clinicaltrials.gov