Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study

Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. Epub 2012 Mar 22.


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.

Trial registration: ClinicalTrials.gov NCT01001494.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Aged
  • Bronchodilator Agents / therapeutic use*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Dyspnea / drug therapy
  • Female
  • Forced Expiratory Volume
  • Health Status
  • Humans
  • Male
  • Metered Dose Inhalers
  • Middle Aged
  • Muscarinic Antagonists / therapeutic use*
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Severity of Illness Index
  • Treatment Outcome
  • Tropanes / therapeutic use*


  • Bronchodilator Agents
  • Muscarinic Antagonists
  • Tropanes
  • aclidinium bromide

Associated data

  • ClinicalTrials.gov/NCT01001494