title: Long-term safety and efficacy of twice-daily aclidinium bromide in patients with COPD.
abstract: BACKGROUND
  Aclidinium is a novel, long-acting muscarinic antagonist indicated for maintenance treatment of COPD.
  
  
  METHODS
  In this 52-week, parallel-group, double-blind study, patients with moderate-to-severe COPD were randomized (1:1) to receive aclidinium twice-daily (BID) 200 μg or 400 μg via a novel, dry powder inhaler (Genuair(®)/Pressair(®)) [Registered trademarks of Almirall, SA, Barcelona, Spain for use within the European Union, Iceland, Norway, and Switzerland as Genuair(®) and within the United States as Pressair(®)]. Safety, the primary objective, was assessed via adverse events (AEs), clinical laboratory tests, vital signs, and 12-lead electrocardiograms. Efficacy was evaluated using spirometry, SGRQ, and rescue medication use.
  
  
  RESULTS
  A total of 605 patients were randomized in the study. The percentage of patients reporting any treatment-emergent AE (TEAE) was comparable between groups; most TEAEs were mild or moderate. Anticholinergic TEAEs were reported by low percentages of patients in either treatment group (dry mouth: 200 μg, 1.3%; 400 μg, 2.7%; constipation: 200 μg, 2.9%; 400 μg, 1.7%). Cardiac TEAEs were also reported by a low percentage of patients (<2% for any event in any group) and did not appear to be dose dependent. There were no clinically relevant abnormalities in other safety outcomes. Both aclidinium 200 μg and 400 μg resulted in improvements from baseline to Week 52 in FEV1, with numerically greater increases observed with the higher dose. Clinically important improvements in SGRQ scores and a reduction in rescue medication use were observed throughout the study for both doses.
  
  
  CONCLUSIONS
  Long-term treatment with aclidinium 200 μg or 400 μg BID was well tolerated, with sustained benefits in lung function and health status in patients with COPD throughout the 1-year study.
authors.affiliation: Southern California Clinical Trials, 3650 E. South Street, Suite 308, Lakewood, CA 90805, USA. Electronic address: afgelb@msn.com.
authors.forename: Arthur F
authors.initials: AF
authors.lastname: Gelb
authors.forename: Donald P
authors.initials: DP
authors.lastname: Tashkin
authors.forename: Barry J
authors.initials: BJ
authors.lastname: Make
authors.forename: Xiaoyun
authors.initials: X
authors.lastname: Zhong
authors.forename: Esther
authors.initials: E
authors.lastname: Garcia Gil
authors.forename: Cynthia
authors.initials: C
authors.lastname: Caracta
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D058492:Drug Repositioning; D058995:Dry Powder Inhalers; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006304:Health Status; D006331:Heart Diseases / Q000139:chemically induced; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D016896:Treatment Outcome; D014326:Tropanes / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D018727:Muscarinic Antagonists; D014326:Tropanes; C542859:aclidinium bromide
keywords: Aclidinium; Bronchodilation; COPD; Health status; Safety; Tolerability