Respirology (Carlton, Vic.) · 2015
Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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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
Аннотация
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.
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.