1Medicines Evaluation Unit, University of Manchester, Manchester, UK2St George's, University of London, London, UK3University of Cape Town, Cape Town, South Africa4Thorax Institute, Hospital Clinic, Barcelona, and CIBER Enfermedades Respiratorias and Fundació Caubet-Cimera, Barcelona, Spain5Almirall S.A., Barcelona, Spain6Forest Research Institute, New Jersey, USA
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Introduction and ObjectivesThe Phase III ATTAIN study investigated the effect of two twice daily doses of aclidinium bromide, a second-generation, long-acting muscarinic antagonist with low systemic activity, in patients with moderate to severe chronic obstructive pulmonary disease (COPD).MethodsIn this 24-week, double-blind study, patients were randomised (1:1:1) to receive aclidinium (200 μg, 400 μg) or placebo, twice daily. The primary endpoint was change from baseline in trough forced expiratory volume in 1 second (FEV1) at Week 24. Other study assessments at 24 weeks included: change from baseline in peak FEV1; percentage of patients achieving a clinically meaningful improvement in St George's Respiratory Questionnaire total score and Transition Dyspnoea Index; COPD symptoms as assessed by the EXACT Respiratory Symptoms score; exacerbation rate based on two definitions (healthcare resource utilisation and EXAcerbations of Chronic pulmonary disease Tool). Adverse events (AEs), clinical laboratory measures, vital signs and ECGs were also assessed.ResultsA total of 819 patients were included in intention-to-treat (ITT) and safety populations. At Week 24, aclidinium 200 μg and 400 μg significantly improved trough FEV1 from baseline compared with placebo (by 99 ml and 128 ml, respectively; both p<0.0001). Aclidinium was significantly superior to placebo at Week 24 for all other study assessments (Abstract P255 table 1). Aclidinium was well tolerated and the incidence of anticholinergic AEs was low and similar to placebo. Changes in laboratory tests, vital signs and ECGs were similar between all groups.ConclusionAclidinium 200 μg and 400 μg twice daily provided clinically meaningful improvements in bronchodilation, health status, symptoms, breathlessness and exacerbation rate. Aclidinium was well tolerated with a similar safety profile for both doses; the incidence of AEs was similar to placebo.