title: Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population.
abstract: 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.
  
  
  BACKGROUND
  NCT01636401 at Clinicaltrials.gov.
authors.affiliation: Department of Internal Medicine, St. Paul's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Sang Haak
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, St. Paul's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Jongmin
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.
authors.forename: Kwang Ha
authors.initials: KH
authors.lastname: Yoo
authors.affiliation: Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
authors.forename: Soo-Taek
authors.initials: ST
authors.lastname: Uh
authors.affiliation: Department of Respiratory and Critical Care Medicine, Kyung Hee University College of Medicine, Seoul, Korea.
authors.forename: Myung Jae
authors.initials: MJ
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
authors.forename: Sang Yeub
authors.initials: SY
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
authors.forename: Jae Yeol
authors.initials: JY
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Seoul Metropolitan Governmental Seoul National University Boramae Medical Center, Seoul, Korea.
authors.forename: Deog Kyeom
authors.initials: DK
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Seung Joon
authors.initials: SJ
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
authors.forename: Kwan Ho
authors.initials: KH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Chul-Gyu
authors.initials: CG
authors.lastname: Yoo
mesh_terms: D000368:Aged; D001993:Bronchodilator Agents / Q000627:therapeutic use; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D018450:Disease Progression; D004311:Double-Blind Method; D058995:Dry Powder Inhalers; D004417:Dyspnea / Q000209:etiology; D005260:Female; D005541:Forced Expiratory Volume; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D056910:Republic of Korea; D012720:Severity of Illness Index; D014326:Tropanes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D001993:Bronchodilator Agents; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D014326:Tropanes; C542859:aclidinium bromide
keywords: aclidinium bromide; cholinergic antagonist; chronic obstructive pulmonary disease; safety; treatment outcome