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

Paul W Jones1*, Stephen I Rennard2, Alvar Agusti3, Pascal Chanez4, Helgo Magnussen5, Leonardo Fabbri6, James F Donohue7, Eric D Bateman8, Nicholas J Gross9, Rosa Lamarca10, Cynthia Caracta11 and Esther Garcia Gil10

Author Affiliations

1 St George's, University of London, London, UK

2 Pulmonary and Critical Care Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA

3 Thorax Institute, Hospital Clínic, Barcelona, and CIBER Enfermedades Respiratorias and Fundació Caubet-Cimera, Spain

4 Département des Maladies Respiratoires, Université de la Mediterranée AP-HM, Marseille, France

5 Pulmonary Research Institute at Hospital Grosshansdorf, Center for Pneumology and Thoracic Surgery, Grosshansdorf, Germany

6 Department of Oncology, Haematology and Respiratory Diseases, University of Modena and Reggio Emilia, Modena, Italy

7 Division of Pulmonary Disease and Critical Care Medicine, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA

8 Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa

9 Stritch-Loyola School of Medicine, Loyola University, Chicago, Illinois, USA

10 Almirall, R&D Centre, Barcelona, Spain

11 Forest Research Institute, New Jersey, USA

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Respiratory Research 2011, 12:55  doi:10.1186/1465-9921-12-55

Published: 26 April 2011

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).

Keywords:
Aclidinium bromide; anticholinergic; chronic obstructive pulmonary disease; long-acting muscarinic antagonist