Comprehensive recommendations will offer new consistency for clinical trials and practice
MONDAY, June 29 (HealthDay News) -- The American Thoracic Society (ATS) and European Respiratory Society (ERS) have issued a comprehensive series of recommendations to standardize asthma definitions and end points for use in clinical trials and practice. The recommendations are published in the July 1 issue of the American Journal of Respiratory and Critical Care Medicine.
Working since 2004, Helen K. Reddel, Ph.D., and colleagues on the ATS/ERS Task Force conducted a review of the medical literature on asthma from 1998 to 2004, including studies on exacerbations, management therapies and outcomes, to determine accepted usage and inconsistencies in terminology and identify appropriate study and clinical end points.
The task force produced "An Official American Thoracic Society/European Respiratory Society Statement: Asthma Control and Exacerbations." The document contains a series of definitions for asthma control, severity, and exacerbations, for both adult and pediatric populations, and also identifies suggested research questions. The recommendations include some notable proposed changes, such as defining "asthma severity" based on disease activity during treatment, rather than prior to treatment. The document also standardizes the definition of the vague term "exacerbation" with reference to specific clinical events.
"The new definitions provide a framework for recommendations regarding the optimum assessment of asthma control in clinical trials. However, these are not the final answers, and the overall landscape may yet change. Further progress will result from integrated studies that variously combine the clinical, physiologic, and/or pathologic measures which, when used to guide treatment, are found to lead to the best outcomes for patients," the authors write.
Numerous task force members reported financial relationships with the pharmaceutical industry.
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