Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease

 

Show simple item record

dc.contributor.author Jones, Paul en_ZA
dc.contributor.author Rennard, Stephen en_ZA
dc.contributor.author Agusti, Alvar en_ZA
dc.contributor.author Chanez, Pascal en_ZA
dc.contributor.author Magnussen, Helgo en_ZA
dc.contributor.author Fabbri, Leonardo en_ZA
dc.contributor.author Donohue, James en_ZA
dc.contributor.author Bateman, Eric en_ZA
dc.contributor.author Gross, Nicholas en_ZA
dc.contributor.author Lamarca, Rosa en_ZA
dc.contributor.author Caracta, Cynthia en_ZA
dc.contributor.author Gil, Esther en_ZA
dc.date.accessioned 2015-11-11T11:53:41Z
dc.date.available 2015-11-11T11:53:41Z
dc.date.issued 2011 en_ZA
dc.identifier.citation Jones, P. W., Rennard, S. I., Agusti, A., Chanez, P., Magnussen, H., Fabbri, L., ... & Gil, E. G. (2011). Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respiratory research, 12(1), 55. en_ZA
dc.identifier.uri http://hdl.handle.net/11427/14859
dc.identifier.uri http://dx.doi.org/10.1186/1465-9921-12-55
dc.description.abstract BACKGROUND: The 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). METHODS: In two double-blind, 52-week studies, ACCLAIM/COPD I (n = 843) and II (n = 804), patients were randomised to inhaled aclidinium 200 mug or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of [less than or equal to]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. RESULTS: At 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 [greater than or equal to]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. CONCLUSION: Aclidinium is effective and well tolerated in patients with moderate to severe COPD.TRIAL REGISTRATION:ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II). en_ZA
dc.language.iso eng en_ZA
dc.publisher BioMed Central Ltd en_ZA
dc.rights This is an Open Access article distributed under the terms of the Creative Commons Attribution License en_ZA
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en_ZA
dc.source Respiratory Research en_ZA
dc.source.uri http://www.respiratory-research.com/ en_ZA
dc.subject.other Aclidinium bromide en_ZA
dc.subject.other anticholinergic en_ZA
dc.subject.other chronic obstructive pulmonary disease en_ZA
dc.subject.other long-acting muscarinic antagonist en_ZA
dc.title Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease en_ZA
dc.type Journal Article en_ZA
dc.rights.holder 2011 Jones et al; licensee BioMed Central Ltd. en_ZA
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Division of Pulmonology en_ZA
uct.type.filetype Text
uct.type.filetype Image


Files in this item

This item appears in the following Collection(s)

Show simple item record

This is an Open Access article distributed under the terms of the Creative Commons Attribution License Except where otherwise noted, this item's license is described as This is an Open Access article distributed under the terms of the Creative Commons Attribution License