Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trialReport as inadecuate




Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial - Download this document for free, or read online. Document in PDF available to download.

BMC Pulmonary Medicine

, 14:209

COPD and occupational lung disease

Abstract

BackgroundThis 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.

MethodsIn 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 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.

ResultsIn 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.

ConclusionsThese results suggest that aclidinium significantly improves exercise endurance, exertional dyspnea, hyperinflation, and physical activity in patients with COPD.

Trial registrationClinicalTrials.gov identifier: NCT01471171; URL: http:-www.clinicaltrials.gov.

KeywordsAclidinium COPD Exercise endurance Long-acting muscarinic antagonists Physical activity AbbreviationsAEAdverse event

BIDTwice daily

CIConfidence interval

COPDChronic obstructive pulmonary disease

EELVEnd-expiratory lung volume

FEV1Forced expiratory volume in 1 s

FRCFunctional residual capacity

FVCForced vital capacity

ICInspiratory capacity

ITTIntent-to-treat

LABALong-acting β2-agonist

LAMALong-acting muscarinic antagonist

PALPhysical activity level

QDOnce daily

RVResidual volume

sGawspecific airway conductance

SpO2Oxygen saturation

TLCTotal lung capacity

ΔTreatment group difference.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2466-14-209 contains supplementary material, which is available to authorized users.

Kai M Beeh, Henrik Watz contributed equally to this work.

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Author: Kai M Beeh - Henrik Watz - Luis Puente-Maestu - Luis de Teresa - Diana Jarreta - Cynthia Caracta - Esther Garcia Gil - He

Source: https://link.springer.com/







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