Research objectives

There is broad agreement that the best available scientific evidence concerning treatment for asthma comes from randomised controlled trials (RCTs). These are most useful when pulled together in a systematic review and aggregated using meta-analysis to produce an estimate of overall treatment efficacy. Such estimates should be reported using a standard measure of outcome, but in the majority of trials, numerous outcomes are used.

A meta-analysis of RCTs using nedocromil showed clear differences in the relative size of the response between different outcomes. For example, asthma symptoms were more responsive than peak flow measurements and FEV1. There is evidence that the size of response in the different outcomes may vary by disease severity and possibly by treatment type. The growth of trials designed to compare different types of drug, each with a possible 'favoured' outcome, makes it important to characterise the response profile for each major class of asthma therapy.

This programme of reviews will carry out a formal evaluation of the measurement properties of each of the outcome measures used routinely in clinical trials in asthma. This will allow a more informed interpretation of results generated by systematic reviews of therapy for asthma and will permit the compilation of a basic set of clinical trial outcome measures for each type of treatment in each setting, based upon trial-proven sensitivity and reliability.

For further information contact

Professor Paul Jones
Professor of Respiratory Medicine
Department of Medicine
Division of Physiological Medicine
St. George's Hospital Medical School
Jenner Wing
Cranmer Terrace
London, SW17 0RE
UK.

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