Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease
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
Respiratory Research 2011, 12:55 doi:10.1186/1465-9921-12-55Published: 26 April 2011
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).
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.
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.
Aclidinium is effective and well tolerated in patients with moderate to severe COPD.