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

Jones, PW; Rennard, SI; Agusti, A; Chanez, P; Magnussen, H; Fabbri, L; Donohue, JF; Bateman, ED; Gross, NJ; Lamarca, R; et al. Jones, PW; Rennard, SI; Agusti, A; Chanez, P; Magnussen, H; Fabbri, L; Donohue, JF; Bateman, ED; Gross, NJ; Lamarca, R; Caracta, C; Gil, EG (2011) Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. RESPIRATORY RESEARCH, 12 (55). ISSN 1465-993X https://doi.org/10.1186/1465-9921-12-55
SGUL Authors: Jones, Paul Wyatt

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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 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. 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≥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.

Item Type: Article
Additional Information: © 2011 Jones et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Administration, Inhalation, Aged, Bronchodilator Agents, Double-Blind Method, Drug Administration Schedule, Dry Powder Inhalers, Dyspnea, Europe, Female, Forced Expiratory Volume, Health Status, Humans, Logistic Models, Lung, Male, Middle Aged, Muscarinic Antagonists, North America, Pulmonary Disease, Chronic Obstructive, Quality of Life, Questionnaires, Severity of Illness Index, Time Factors, Treatment Outcome, Tropanes, Science & Technology, Life Sciences & Biomedicine, Respiratory System, Aclidinium bromide anticholinergic, chronic obstructive pulmonary disease, long-acting muscarinic antagonist, LUNG-FUNCTION, TIOTROPIUM, COPD, TRIAL, BROMIDE, EXACERBATIONS, PREVENTION, SALMETEROL, OUTCOMES
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: RESPIRATORY RESEARCH
ISSN: 1465-993X
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Dates:
DateEvent
26 April 2011Published
Web of Science ID: WOS:000290870000001
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URI: http://openaccess.sgul.ac.uk/id/eprint/2069
Publisher's version: https://doi.org/10.1186/1465-9921-12-55

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