title: Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease.
abstract: BACKGROUND
  The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
  
  
  METHODS
  In two double-blind, 52-week studies, ACCLAIM/COPD I (n=843) and II (n=804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1<80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation.
  
  
  RESULTS
  At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p<0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p<0.001). More patients had a SGRQ improvement≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p=0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p=0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p=0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p=0.9). Adverse events were minor in both studies.
  
  
  CONCLUSIONS
  Aclidinium is effective and well tolerated in patients with moderate to severe COPD.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II).
authors.affiliation: St George's, University of London, London, UK. pjones@sgul.ac.uk
authors.forename: Paul W
authors.initials: PW
authors.lastname: Jones
authors.forename: Stephen I
authors.initials: SI
authors.lastname: Rennard
authors.forename: Alvar
authors.initials: A
authors.lastname: Agusti
authors.forename: Pascal
authors.initials: P
authors.lastname: Chanez
authors.forename: Helgo
authors.initials: H
authors.lastname: Magnussen
authors.forename: Leonardo
authors.initials: L
authors.lastname: Fabbri
authors.forename: James F
authors.initials: JF
authors.lastname: Donohue
authors.forename: Eric D
authors.initials: ED
authors.lastname: Bateman
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Gross
authors.forename: Rosa
authors.initials: R
authors.lastname: Lamarca
authors.forename: Cynthia
authors.initials: C
authors.lastname: Caracta
authors.forename: Esther Garcia
authors.initials: EG
authors.lastname: Gil
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D058995:Dry Powder Inhalers; D004417:Dyspnea / Q000188:drug therapy / Q000503:physiopathology; D005060:Europe; D005260:Female; D005541:Forced Expiratory Volume; D006304:Health Status; D006801:Humans; D016015:Logistic Models; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D009656:North America; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014326:Tropanes / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001993:Bronchodilator Agents; D018727:Muscarinic Antagonists; D014326:Tropanes; C542859:aclidinium bromide