Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population. Issue 8 (15th September 2015)

• Record Type: Journal Article
• Authors: Lee, Sang Haak; Lee, Jongmin; Yoo, Kwang Ha; Uh, Soo‐Taek; Park, Myung Jae; Lee, Sang Yeub; Kim, Jae Yeol; Kim, Deog Kyeom; Kim, Seung Joon; Lee, Kwan Ho; Yoo, Chul‐Gyu
• Is Part Of: Respirology. Volume 20:Issue 8(2015)
• Page Start: 1222
• Page End: 1228
• Publication Date: 2015-09-15
• Subjects: Respiratory organs -- Diseases -- Periodicals; Respiratory organs -- Periodicals; 612.2
• DOI: 10.1111/resp.12641
• Languages: English
• ISSNs: 1323-7799

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="resp12641-sec-0001" sec-type="section"> <title>Background and objective</title> <p>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.</p> </sec> <sec id="resp12641-sec-0002" sec-type="section"> <title>Methods</title> <p>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 (FEV<sub>1</sub>) 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.</p> </sec> <sec id="resp12641-sec-0003" sec-type="section"> <title>Results</title> <p>A significant improvement in trough FEV<sub>1</sub> from baseline was shown with aclidinium compared with the placebo (0.126 L, <italic>P</italic> < 0.0001). Significant improvements were also demonstrated in peak FEV<sub>1</sub> (0.190 L, <italic>P</italic> < 0.0001), SGRQ and TDI. Furthermore, aclidinium significantly reduced the prevalence of exacerbations (aclidinium, 5.4%; placebo, 15.6%, <italic>P</italic> < 0.05), and the duration of exacerbations was shorter compared with placebo (rate ratio: 0.27; <italic>P</italic> < 0.05). Aclidinium (400 μg) was well tolerated and the prevalence of adverse events was comparable with the placebo.</p> </sec> <sec id="resp12641-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Inhaled aclidinium (400 μg) was shown to be safe and efficacious in Korean patients with moderate‐to‐severe COPD.</p> <p> <bold>Clinical trial registration:</bold> NCT01636401 at Clinicaltrials.gov</p> </sec> </abstract>