title: Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial.
abstract: BACKGROUND
  This study evaluated the effects of aclidinium bromide, a long-acting muscarinic antagonist indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD), on exercise endurance, dyspnea, lung hyperinflation, and physical activity.
  
  
  METHODS
  In this randomized, double-blind, crossover study, patients with stable COPD and moderate-to-severe airflow limitation received aclidinium 400 μg twice daily or placebo via Genuair®/Pressair(®a) for 3 weeks (2-week washout between treatment periods). The primary endpoint was change from baseline to Week 3 in endurance time, measured by constant work rate cycle ergometry testing at 75% peak incremental work rate. Changes from baseline in intensity of exertional dyspnea (Borg CR10 Scale®) and trough inspiratory capacity were secondary endpoints. Additional endpoints included changes from baseline in other spirometric, plethysmographic, and physical activity (assessed by objective accelerometer measurement) parameters. Efficacy endpoints were analyzed using an analysis of covariance model.
  
  
  RESULTS
  In total, 112 patients were randomized and treated (mean age 60.3 years; mean post-bronchodilator forced expiratory volume in 1 s 1.7 L [56.7% predicted]; mean endurance time 485.7 s). After 3 weeks, endurance time was significantly increased with aclidinium versus placebo (treatment difference 58.5 s; p < 0.05). At Week 3, aclidinium significantly reduced dyspnea intensity at isotime during exercise (treatment difference -0.63; p < 0.05) and improved trough inspiratory capacity (treatment difference 78 mL; p < 0.05) versus placebo. Significant improvements in spirometric, plethysmographic, and some physical activity parameters were observed with aclidinium versus placebo.
  
  
  CONCLUSIONS
  These results suggest that aclidinium significantly improves exercise endurance, exertional dyspnea, hyperinflation, and physical activity in patients with COPD.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01471171; URL: http://www.clinicaltrials.gov.
authors.forename: Kai M
authors.initials: KM
authors.lastname: Beeh
authors.forename: Henrik
authors.initials: H
authors.lastname: Watz
authors.forename: Luis
authors.initials: L
authors.lastname: Puente-Maestu
authors.forename: Luis
authors.initials: L
authors.lastname: de Teresa
authors.forename: Diana
authors.initials: D
authors.lastname: Jarreta
authors.forename: Cynthia
authors.initials: C
authors.lastname: Caracta
authors.forename: Esther
authors.initials: E
authors.lastname: Garcia Gil
authors.affiliation: Pulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Centre North, German Centre for Lung Research, Woehrendamm 80, D-22927 Grosshansdorf, Germany. magnussen@pulmoresearch.de.
authors.forename: Helgo
authors.initials: H
authors.lastname: Magnussen
mesh_terms: D061725:Accelerometry; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004417:Dyspnea / Q000188:drug therapy* / Q000209:etiology; D017079:Exercise Tolerance; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D010807:Physical Endurance; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D014326:Tropanes / Q000627:therapeutic use*
chemical_list: D018727:Muscarinic Antagonists; D014326:Tropanes; C542859:aclidinium bromide