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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of twice-daily aclidinium bromide in COPD patients: The ATTAIN study
European Respiratory Journal, Volume 40, No. 4, Year 2012
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Description
The efficacy and safety of two doses of aclidinium bromide were evaluated in patients with moderate to severe chronic obstructive pulmonary disease (COPD). In this 24-week, double-blind trial, patients were randomised to twice-daily aclidinium (200 mg or 400 mg) or placebo. The primary efficacy end-point was change in trough forced expiratory volume in 1 s (FEV1) at week 24. Other end-points included peak FEV1, health status (St George's Respiratory Questionnaire; SGRQ) and dyspnoea (Transitional Dyspnoea Index; TDI). Overall, 828 patients were randomised. At week 24, significant improvements from baseline were observed with aclidinium 200 mg and 400 mg versus placebo for trough FEV1 (99 and 128 mL; both p<0.0001) and peak FEV1 (185 and 209 mL; both p<0.0001). Peak FEV1 improvements on day 1 were comparable with week 24. Aclidinium 200 mg and 400 mg produced significant improvements over placebo in baseline-adjusted mean SGRQ total score (-3.8 and -4.6 units; p<0.001 and p<0.0001) and TDI focal score (0.6 and 1.0 units; p<0.05 and p<0.001) at week 24. With both aclidinium doses, the incidence of anticholinergic adverse events was low, and similar to placebo. Twice-daily aclidinium significantly improved bronchodilation, health status and dyspnoea, and was well tolerated in patients with COPD. Copyright©ERS 2012.
Authors & Co-Authors
Jones, Paul Wyatt
United Kingdom, London
St George’s, University of London
Singh, Dave
United Kingdom, Manchester
The University of Manchester
Bateman, E. D.
South Africa, Cape Town
University of Cape Town
Agustí, Àlvar G.N.
Spain, Barcelona
Universitat de Barcelona
Spain, Madrid
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias
Lamarca, Rosa
Spain, Barcelona
Laboratorios Almirall
De-Miquel, Gonzalo
Spain, Barcelona
Laboratorios Almirall
Segarra, Rosa Maria
Spain, Barcelona
Laboratorios Almirall
Caractae, Cynthia
United States, New York
Forest Laboratories, Inc
Gi, Esther Garcia
Spain, Barcelona
Laboratorios Almirall
Statistics
Citations: 191
Authors: 9
Affiliations: 7
Identifiers
Doi:
10.1183/09031936.00225511
ISSN:
09031936
e-ISSN:
13993003
Research Areas
Disability
Noncommunicable Diseases
Study Design
Cohort Study