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- Title
Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial.
- Authors
Beeh, Kai M.; Watz, Henrik; Puente-Maestu, Luis; de Teresa, Luis; Jarreta, Diana; Caracta, Cynthia; Gil, Esther Garcia; Magnussen, Helgo
- 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 moderate-to-severe COPD 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 postbronchodilator 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. Trial registration ClinicalTrials.gov identifier: NCT01471171; URL: www.clinicaltrials.gov.
- Subjects
DRUG efficacy; OBSTRUCTIVE lung disease treatment; EXERCISE; DYSPNEA; PHYSICAL activity; CROSSOVER trials; ERGOMETRY; ANALYSIS of covariance
- Publication
BMC Pulmonary Medicine, 2014, Vol 14, Issue 1, p301
- ISSN
1471-2466
- Publication type
Article
- DOI
10.1186/1471-2466-14-209