Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study

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dc.contributor.authorSingh, Dave
dc.contributor.authorJones, Paul W
dc.contributor.authorBateman, Eric D
dc.contributor.authorKorn, Stephanie
dc.contributor.authorSerra, Cristina
dc.contributor.authorMolins, Eduard
dc.contributor.authorCaracta, Cynthia
dc.contributor.authorGil, Esther G
dc.contributor.authorLeselbaum, Anne
dc.date.accessioned2015-07-30T04:09:06Z
dc.date.available2015-07-30T04:09:06Z
dc.date.issued2014-11-18
dc.date.updated2015-01-15T17:53:19Z
dc.description.abstractAbstract Background Aclidinium/formoterol is a twice-daily (BID) fixed-dose combination (FDC) in development for chronic obstructive pulmonary disease (COPD). The efficacy and safety of aclidinium/formoterol versus monotherapy and placebo in patients with COPD was assessed. Methods In this 24-week double-blind, parallel-group, active- and placebo-controlled, multicentre Phase III study, patients (≥40 years, post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity <70% and FEV1 ≥30% but <80% predicted normal) were randomised 2:2:2:2:1 to aclidinium/formoterol 400/12 μg (n = 385) or 400/6 μg (n = 381), aclidinium 400 μg (n = 385), formoterol 12 μg (n = 384) or placebo (n = 194) BID via Genuair®/Pressair®a. Results At Week 24, aclidinium/formoterol 400/12 μg and 400/6 μg lead to significant improvements from baseline in 1-hour post-dose FEV1 versus aclidinium (125 mL [95% CI: 90, 160; p < 0 · 001] and 69 mL [95% CI: 34, 105; p < 0.001], respectively) and trough FEV1 versus formoterol (85 mL [95% CI: 51, 119; p < 0.001] and 53 mL [95% CI: 19, 87; p < 0.01], respectively; co-primary endpoints). Additionally, aclidinium/formoterol 400/12 μg and 400/6 μg provided significant improvements in Transition Dyspnoea Index (TDI) focal score versus placebo (1.29 units [95% CI: 0.73, 1.86; p < 0.001] and 1.16 units [95% CI: 0.59, 1.73; p < 0.001], respectively; secondary endpoint). All treatments were well tolerated, with safety profiles of the FDCs similar to those of placebo and monotherapy. Conclusions Both aclidinium/formoterol BID doses significantly improved bronchodilation versus monotherapy, and dyspnoea versus placebo, with no increase in safety risk. Aclidinium/formoterol may be an effective treatment for patients with COPD. Trial registration ClinicalTrials.gov: NCT01462942 .
dc.identifier.apacitationSingh, D., Jones, P. W., Bateman, E. D., Korn, S., Serra, C., Molins, E., ... Leselbaum, A. (2014). Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. <i>BMC Pulmonary Medicine</i>, http://hdl.handle.net/11427/13619en_ZA
dc.identifier.chicagocitationSingh, Dave, Paul W Jones, Eric D Bateman, Stephanie Korn, Cristina Serra, Eduard Molins, Cynthia Caracta, Esther G Gil, and Anne Leselbaum "Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study." <i>BMC Pulmonary Medicine</i> (2014) http://hdl.handle.net/11427/13619en_ZA
dc.identifier.citationSingh, D., Jones, P. W., Bateman, E. D., Korn, S., Serra, C., Molins, E., ... & Leselbaum, A. (2014). Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC pulmonary medicine, 14(1), 178.
dc.identifier.ris TY - Journal Article AU - Singh, Dave AU - Jones, Paul W AU - Bateman, Eric D AU - Korn, Stephanie AU - Serra, Cristina AU - Molins, Eduard AU - Caracta, Cynthia AU - Gil, Esther G AU - Leselbaum, Anne AB - Abstract Background Aclidinium/formoterol is a twice-daily (BID) fixed-dose combination (FDC) in development for chronic obstructive pulmonary disease (COPD). The efficacy and safety of aclidinium/formoterol versus monotherapy and placebo in patients with COPD was assessed. Methods In this 24-week double-blind, parallel-group, active- and placebo-controlled, multicentre Phase III study, patients (≥40 years, post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity <70% and FEV1 ≥30% but <80% predicted normal) were randomised 2:2:2:2:1 to aclidinium/formoterol 400/12 μg (n = 385) or 400/6 μg (n = 381), aclidinium 400 μg (n = 385), formoterol 12 μg (n = 384) or placebo (n = 194) BID via Genuair®/Pressair®a. Results At Week 24, aclidinium/formoterol 400/12 μg and 400/6 μg lead to significant improvements from baseline in 1-hour post-dose FEV1 versus aclidinium (125 mL [95% CI: 90, 160; p < 0 · 001] and 69 mL [95% CI: 34, 105; p < 0.001], respectively) and trough FEV1 versus formoterol (85 mL [95% CI: 51, 119; p < 0.001] and 53 mL [95% CI: 19, 87; p < 0.01], respectively; co-primary endpoints). Additionally, aclidinium/formoterol 400/12 μg and 400/6 μg provided significant improvements in Transition Dyspnoea Index (TDI) focal score versus placebo (1.29 units [95% CI: 0.73, 1.86; p < 0.001] and 1.16 units [95% CI: 0.59, 1.73; p < 0.001], respectively; secondary endpoint). All treatments were well tolerated, with safety profiles of the FDCs similar to those of placebo and monotherapy. Conclusions Both aclidinium/formoterol BID doses significantly improved bronchodilation versus monotherapy, and dyspnoea versus placebo, with no increase in safety risk. Aclidinium/formoterol may be an effective treatment for patients with COPD. Trial registration ClinicalTrials.gov: NCT01462942 . DA - 2014-11-18 DB - OpenUCT DO - 10.1186/1471-2466-14-178 DP - University of Cape Town J1 - BMC Pulmonary Medicine LK - https://open.uct.ac.za PB - University of Cape Town PY - 2014 T1 - Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study TI - Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study UR - http://hdl.handle.net/11427/13619 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/13619
dc.identifier.urihttp://dx.doi.org/10.1186/1471-2466-14-178
dc.identifier.vancouvercitationSingh D, Jones PW, Bateman ED, Korn S, Serra C, Molins E, et al. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulmonary Medicine. 2014; http://hdl.handle.net/11427/13619.en_ZA
dc.language.rfc3066en
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 License*
dc.rights.holderSingh et al.; licensee BioMed Central Ltd.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0*
dc.sourceBMC Pulmonary Medicineen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcpulmmed/
dc.subject.otherAclidinium bromide/formoterol fumarateen_ZA
dc.subject.otherChronic obstructive pulmonary diseaseen_ZA
dc.subject.otherFixed-dose combinationen_ZA
dc.titleEfficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study
dc.typeJournal Articleen_ZA
uct.type.filetype
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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