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

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Creator
  • Donohue, James F
    • Affiliation: School of Medicine, Department of Medicine, Division of Pulmonary Diseases and Critical Care Medicine
  • Bateman, Eric D
    • Other Affiliation: Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa
  • Agusti, Alvar
    • Other Affiliation: Thorax Institute, Hospital Clínic, Barcelona, and CIBER Enfermedades Respiratorias and Fundació Caubet-Cimera, Spain
  • Chanez, Pascal
    • Other Affiliation: Département des Maladies Respiratoires, Université de la Mediterranée AP-HM, Marseille, France
  • Lamarca, Rosa
    • Other Affiliation: Almirall, R&D Centre, Barcelona, Spain
  • Magnussen, Helgo
    • Other Affiliation: Pulmonary Research Institute at Hospital Grosshansdorf, Center for Pneumology and Thoracic Surgery, Grosshansdorf, Germany
  • Rennard, Stephen I
    • Other Affiliation: Pulmonary and Critical Care Medicine, University of Nebraska Medical Center, Omaha, USA
  • Fabbri, Leonardo
    • Other Affiliation: Department of Oncology, Haematology and Respiratory Diseases, University of Modena and Reggio Emilia, Modena, Italy
  • Caracta, Cynthia
    • Other Affiliation: Forest Research Institute, New Jersey, USA
  • Jones, Paul W
    • Other Affiliation: St George's, University of London, London, UK
  • Gross, Nicholas J
    • Other Affiliation: Stritch-Loyola School of Medicine, Loyola University, Chicago, USA
  • Gil, Esther G
    • Other Affiliation: Almirall, R&D Centre, Barcelona, Spain
Abstract
  • 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. Trial registration ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II).
Date of publication
Identifier
  • doi:10.1186/1465-9921-12-55
Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • Jones et al; licensee BioMed Central Ltd.
Language
  • English
Bibliographic citation
  • Respiratory Research. 2011 Dec 01;12(1):55
Publisher
  • BioMed Central
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