, Volume 16, Issue 3, pp 115-127
Date: 24 Aug 2012

Recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma

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Introduction

Asthma is a chronic inflammatory disorder of the airways resulting in airway re-modelling with increased responsiveness to exogenous and endogenous stimuli, and variable airflow limitation 1,2. Asthma prevalence varies worldwide, being highest in Western Europe, North America, Australia and New Zealand and lowest in Central and Eastern Europe, Africa and Asia. Prevalence figures for Western Europe range from 7-12% in adults and 17-22% in children 3. As countries adopt a more ‘Western’ lifestyle, the disease prevalence increases, suggesting that important environmental factors influence its pathogenesis. In its typical form, asthma has its onset in early childhood and presents with symptoms of wheezing, breathlessness and cough, occurring either spontaneously or in response to external stimuli. The disease has a varying natural history, ranging from a transient disease of childhood through to persistent severe disease throughout life. Longitudinal studies have shown that ear ...

Other contributors to the GREES Group were: E. Abadie (European Medicines Evaluation Agency), K. Besthorn (Merck Sharp and Dohme), G. Braunstein (GlaxoSmithKline), C. Bremard-Oury (Aventis), G. Calvo (Medical Research Council), E. Didier (AstraZeneca), M. Lopez-Vidriero, A. Rames (Boehringer Ingelheim), T. Reiss (Merck & Co Inc.)