BMC Pulmonary Medicine | |
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 | |
Anne Leselbaum8  Esther Garcia Gil6  Cynthia Caracta5  Eduard Molins6  Cristina Serra3  Stephanie Korn1  Eric D Bateman2  Paul W Jones7  Dave Singh4  | |
[1] Pulmonary Department, Mainz University Hospital, Mainz, Germany;Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa;Almirall R&D Centre, Almirall, Barcelona, Spain;University of Manchester, Medicines Evaluation Unit, Langley Building, University Hospital of South Manchester NHS Foundation Trust, Southmoor Road, Manchester M23 9QZ, UK;Formerly of Forest Research Institute, Forest Laboratories LLC, a subsidiary of Actavis, Jersey City, NJ, USA;AstraZeneca PLC, Barcelona, Spain;Infection and Immunity Institute, St George’s, University of London, London, UK;Formerly of Almirall S.A., Barcelona, Spain | |
关键词: Fixed-dose combination; Chronic obstructive pulmonary disease; Aclidinium bromide/formoterol fumarate; | |
Others : 1091380 DOI : 10.1186/1471-2466-14-178 |
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received in 2014-06-13, accepted in 2014-11-03, 发布年份 2014 | |
【 摘 要 】
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.
【 授权许可】
2014 Singh et al.; licensee BioMed Central Ltd.
【 预 览 】
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20150128171550139.pdf | 774KB | download | |
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Figure 1. | 41KB | Image | download |
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