help button home button
AJRCCM
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Online Supplement
Right arrow Link to Free PDF Version on ATS Website
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Google Scholar
Right arrow Articles by Reddel, H. K.
PubMed
Right arrow Articles by Reddel, H. K.
American Journal of Respiratory and Critical Care Medicine Vol 180. pp. 59-99, (2009)
© 2009 American Thoracic Society
doi: 10.1164/rccm.200801-060ST

American Thoracic Society Documents

An Official American Thoracic Society/European Respiratory Society Statement: Asthma Control and Exacerbations

Standardizing Endpoints for Clinical Asthma Trials and Clinical Practice

Helen K. Reddel, D. Robin Taylor, Eric D. Bateman, Louis-Philippe Boulet, Homer A. Boushey, William W. Busse, Thomas B. Casale, Pascal Chanez, Paul L. Enright, Peter G. Gibson, Johan C. de Jongste, Huib A. M. Kerstjens, Stephen C. Lazarus, Mark L. Levy, Paul M. O'Byrne, Martyn R. Partridge, Ian D. Pavord, Malcolm R. Sears, Peter J. Sterk, Stuart W. Stoloff, Sean D. Sullivan, Stanley J. Szefler, Mike D. Thomas, Sally E. Wenzel on behalf of the American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations

Background: The assessment of asthma control is pivotal to the evaluation of treatment response in individuals and in clinical trials. Previously, asthma control, severity, and exacerbations were defined and assessed in many different ways.

Purpose: The Task Force was established to provide recommendations about standardization of outcomes relating to asthma control, severity, and exacerbations in clinical trials and clinical practice, for adults and children aged 6 years or older.

Methods: A narrative literature review was conducted to evaluate the measurement properties and strengths/weaknesses of outcome measures relevant to asthma control and exacerbations. The review focused on diary variables, physiologic measurements, composite scores, biomarkers, quality of life questionnaires, and indirect measures.

Results: The Task Force developed new definitions for asthma control, severity, and exacerbations, based on current treatment principles and clinical and research relevance. In view of current knowledge about the multiple domains of asthma and asthma control, no single outcome measure can adequately assess asthma control. Its assessment in clinical trials and in clinical practice should include components relevant to both of the goals of asthma treatment, namely achievement of best possible clinical control and reduction of future risk of adverse outcomes. Recommendations are provided for the assessment of asthma control in clinical trials and clinical practice, both at baseline and in the assessment of treatment response.

Conclusions: The Task Force recommendations provide a basis for a multicomponent assessment of asthma by clinicians, researchers, and other relevant groups in the design, conduct, and evaluation of clinical trials, and in clinical practice.

Key Words: asthma control • asthma exacerbations • asthma severity • clinical trials • outcome assessment (health care) • predictive value of tests






HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Proc. Am. Thorac. Soc. Am. J. Respir. Cell Mol. Biol.
Copyright © 2009 American Thoracic Society 		  Membership Renewal