title: Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study.
abstract: The efficacy and safety of two doses of aclidinium bromide were evaluated in patients with moderate to severe chronic obstructive pulmonary disease (COPD). In this 24-week, double-blind trial, patients were randomised to twice-daily aclidinium (200 μg or 400 μg) or placebo. The primary efficacy end-point was change in trough forced expiratory volume in 1 s (FEV(1)) at week 24. Other end-points included peak FEV(1), health status (St George's Respiratory Questionnaire; SGRQ) and dyspnoea (Transitional Dyspnoea Index; TDI). Overall, 828 patients were randomised. At week 24, significant improvements from baseline were observed with aclidinium 200 μg and 400 μg versus placebo for trough FEV(1) (99 and 128 mL; both p<0.0001) and peak FEV(1) (185 and 209 mL; both p<0.0001). Peak FEV(1) improvements on day 1 were comparable with week 24. Aclidinium 200 μg and 400 μg produced significant improvements over placebo in baseline-adjusted mean SGRQ total score (-3.8 and -4.6 units; p<0.001 and p<0.0001) and TDI focal score (0.6 and 1.0 units; p<0.05 and p<0.001) at week 24. With both aclidinium doses, the incidence of anticholinergic adverse events was low, and similar to placebo. Twice-daily aclidinium significantly improved bronchodilation, health status and dyspnoea, and was well tolerated in patients with COPD.
authors.affiliation: St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK. pjones@sgul.ac.uk
authors.forename: Paul W
authors.initials: PW
authors.lastname: Jones
authors.forename: Dave
authors.initials: D
authors.lastname: Singh
authors.forename: Eric D
authors.initials: ED
authors.lastname: Bateman
authors.forename: Alvar
authors.initials: A
authors.lastname: Agusti
authors.forename: Rosa
authors.initials: R
authors.lastname: Lamarca
authors.forename: Gonzalo
authors.initials: G
authors.lastname: de Miquel
authors.forename: Rosa
authors.initials: R
authors.lastname: Segarra
authors.forename: Cynthia
authors.initials: C
authors.lastname: Caracta
authors.forename: Esther
authors.initials: E
authors.lastname: Garcia Gil
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004417:Dyspnea / Q000188:drug therapy; D005260:Female; D005541:Forced Expiratory Volume; D006304:Health Status; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014326:Tropanes / Q000627:therapeutic use*
chemical_list: D001993:Bronchodilator Agents; D018727:Muscarinic Antagonists; D014326:Tropanes; C542859:aclidinium bromide