Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary diseaseReport as inadecuate

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Respiratory Research

, 12:55

First Online: 01 December 2011Received: 22 December 2010Accepted: 26 April 2011


BackgroundThe long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease COPD.

MethodsIn two double-blind, 52-week studies, ACCLAIM-COPD I n = 843 and II n = 804, patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second FEV1-forced vital capacity ratio of ≤70% and FEV1 <80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George-s Respiratory Questionnaire SGRQ and time to first moderate or severe COPD exacerbation.

ResultsAt 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM-COPD I by 61 and 67 mL; both p < 0.001 and ACCLAIM-COPD II by 63 and 59 mL; both p < 0.001. More patients had a SGRQ improvement ≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM-COPD I 48.1% versus 39.5%; p = 0.025 and ACCLAIM-COPD II 39.0% versus 32.8%; p = 0.074. The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM-COPD II hazard ratio HR 0.7; 95% confidence interval CI 0.55 to 0.92; p = 0.01, but not ACCLAIM-COPD I HR 1.0; 95% CI 0.72 to 1.33; p = 0.9. Adverse events were minor in both studies.

ConclusionAclidinium is effective and well tolerated in patients with moderate to severe COPD.

Trial registrationClinicalTrials.gov: NCT00363896 ACCLAIM-COPD I and NCT00358436 ACCLAIM-COPD II.

KeywordsAclidinium bromide anticholinergic chronic obstructive pulmonary disease long-acting muscarinic antagonist List of abbreviations usedAEadverse event

ANCOVAanalysis of covariance

ATSAmerican Thoracic Society

BDIBaseline Dyspnoea Index

CIconfidence interval

COPDchronic obstructive pulmonary disease


ERSEuropean Respiratory Society

FEV1forced expiratory volume in 1 second

FVCforced vital capacity

HRhazard ratio

MCIDminimal clinically important difference

SAEserious adverse event

SGRQSt George-s Respiratory Questionnaire

TDITransitional Dyspnoea Index

Electronic supplementary materialThe online version of this article doi:10.1186-1465-9921-12-55 contains supplementary material, which is available to authorized users.

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Author: Paul W Jones - Stephen I Rennard - Alvar Agusti - Pascal Chanez - Helgo Magnussen - Leonardo Fabbri - James F Donohue -

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

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