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

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dc.contributor.authorJones, Paulen_ZA
dc.contributor.authorRennard, Stephenen_ZA
dc.contributor.authorAgusti, Alvaren_ZA
dc.contributor.authorChanez, Pascalen_ZA
dc.contributor.authorMagnussen, Helgoen_ZA
dc.contributor.authorFabbri, Leonardoen_ZA
dc.contributor.authorDonohue, Jamesen_ZA
dc.contributor.authorBateman, Ericen_ZA
dc.contributor.authorGross, Nicholasen_ZA
dc.contributor.authorLamarca, Rosaen_ZA
dc.contributor.authorCaracta, Cynthiaen_ZA
dc.contributor.authorGil, Estheren_ZA
dc.date.accessioned2015-11-11T11:53:41Z
dc.date.available2015-11-11T11:53:41Z
dc.date.issued2011en_ZA
dc.description.abstractBACKGROUND: 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.identifier.apacitationJones, P., Rennard, S., Agusti, A., Chanez, P., Magnussen, H., Fabbri, L., ... Gil, E. (2011). Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. <i>Respiratory Research</i>, http://hdl.handle.net/11427/14859en_ZA
dc.identifier.chicagocitationJones, Paul, Stephen Rennard, Alvar Agusti, Pascal Chanez, Helgo Magnussen, Leonardo Fabbri, James Donohue, et al "Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease." <i>Respiratory Research</i> (2011) http://hdl.handle.net/11427/14859en_ZA
dc.identifier.citationJones, 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.ris TY - Journal Article AU - Jones, Paul AU - Rennard, Stephen AU - Agusti, Alvar AU - Chanez, Pascal AU - Magnussen, Helgo AU - Fabbri, Leonardo AU - Donohue, James AU - Bateman, Eric AU - Gross, Nicholas AU - Lamarca, Rosa AU - Caracta, Cynthia AU - Gil, Esther AB - 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). DA - 2011 DB - OpenUCT DO - 10.1186/1465-9921-12-55 DP - University of Cape Town J1 - Respiratory Research LK - https://open.uct.ac.za PB - University of Cape Town PY - 2011 T1 - Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease TI - Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease UR - http://hdl.handle.net/11427/14859 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14859
dc.identifier.urihttp://dx.doi.org/10.1186/1465-9921-12-55
dc.identifier.vancouvercitationJones P, Rennard S, Agusti A, Chanez P, Magnussen H, Fabbri L, et al. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respiratory Research. 2011; http://hdl.handle.net/11427/14859.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDivision of Pulmonologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2011 Jones et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceRespiratory Researchen_ZA
dc.source.urihttp://www.respiratory-research.com/en_ZA
dc.subject.otherAclidinium bromideen_ZA
dc.subject.otheranticholinergicen_ZA
dc.subject.otherchronic obstructive pulmonary diseaseen_ZA
dc.subject.otherlong-acting muscarinic antagonisten_ZA
dc.titleEfficacy and safety of once-daily aclidinium in chronic obstructive pulmonary diseaseen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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