Efficacy and safety of aclidinium bromide in patients with COPD

A phase 3 randomized clinical trial in a Korean population

Sang Haak Lee, Jongmin Lee, Kwang Ha Yoo, Soo Taek Uh, Myung Jae Park, Sang Yeub Lee, Jae Yeol Kim, Deog Kyeom Kim, Seung Joon Kim, Kwan Ho Lee, Chul Gyu Yoo

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
Pages (from-to)1222-1228
Number of pages7
JournalRespirology
Volume20
Issue number8
DOIs
Publication statusPublished - 2015 Nov 1

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Phase III Clinical Trials
Chronic Obstructive Pulmonary Disease
Randomized Controlled Trials
Placebos
Safety
Dyspnea
Population
Clinical Trials
Dry Powder Inhalers
Muscarinic Antagonists
Forced Expiratory Volume
Therapeutic Uses
Health Status
Disease Progression
aclidinium bromide
Lung

Keywords

  • aclidinium bromide
  • cholinergic antagonist
  • chronic obstructive pulmonary disease
  • safety
  • treatment outcome

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

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

In: Respirology, Vol. 20, No. 8, 01.11.2015, p. 1222-1228.

Research output: Contribution to journalArticle

Lee, SH, Lee, J, Yoo, KH, Uh, ST, Park, MJ, Lee, SY, Kim, JY, Kim, DK, Kim, SJ, Lee, KH & Yoo, CG 2015, 'Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population', Respirology, vol. 20, no. 8, pp. 1222-1228. https://doi.org/10.1111/resp.12641
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. / Efficacy and safety of aclidinium bromide in patients with COPD : A phase 3 randomized clinical trial in a Korean population. In: Respirology. 2015 ; Vol. 20, No. 8. pp. 1222-1228.
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abstract = "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.",
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AU - Lee, Sang Yeub

AU - Kim, Jae Yeol

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