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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease
Respiratory Research, Volume 12, Article 55, Year 2011
Notification
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Description
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.Trial registration: ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II). © 2011 Jones et al; licensee BioMed Central Ltd.
Authors & Co-Authors
Jones, Paul Wyatt
United Kingdom, London
St George’s, University of London
Rennard, Stephen I.
United States, Omaha
University of Nebraska Medical Center
Agustí, Àlvar G.N.
Spain, Barcelona
Hospital Clinic Barcelona
Spain, Madrid
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias
Chanez, Pascal
France, Marseille
Aix Marseille Université
Magnussen, Helgo
Germany, Grosshansdorf
Krankenhaus Großhansdorf
Fabbri, Leonardo M.
Italy, Modena
Università Degli Studi Di Modena e Reggio Emilia
Donohue, James F.
United States, Chapel Hill
Unc School of Medicine
Bateman, E. D.
South Africa, Cape Town
University of Cape Town
Gross, Nicholas J.
United States, Maywood
Loyola University Stritch School of Medicine
Lamarca, Rosa
Spain, Barcelona
Laboratorios Almirall
Caracta, Cynthia F.
United States, Jersey City
Forest Research Institute
García-Gil, Esther
Spain, Barcelona
Laboratorios Almirall
Statistics
Citations: 82
Authors: 12
Affiliations: 12
Identifiers
Doi:
10.1186/1465-9921-12-55
ISSN:
14659921
e-ISSN:
1465993X
Research Areas
Disability
Environmental
Noncommunicable Diseases