TY - JOUR
T1 - An Official American Thoracic Society/European Respiratory Society Statement
T2 - Asthma Control and Exacerbations Standardising Endpoints for Clinical Asthma Trials and Clinical Practice
AU - Reddel, Helen K.
AU - Taylor, D. Robin
AU - Bateman, Eric D.
AU - Boulet, Louis-Philippe
AU - Boushey, Homer A.
AU - Busse, William W.
AU - Casale, Thomas B.
AU - Chanez, Pascal
AU - Enright, Paul L.
AU - Gibson, Peter G.
AU - de Jongste, Johan C.
AU - Kerstjens, Huib A. M.
AU - Lazarus, Stephen C.
AU - Levy, Mark L.
AU - O'Byrne, Paul M.
AU - Partridge, Martyn R.
AU - Pavord, Ian D.
AU - Sears, Malcolm R.
AU - Sterk, Peter J.
AU - Stoloff, Stuart W.
AU - Sullivan, Sean D.
AU - Szefler, Stanley J.
AU - Thomas, Mike D.
AU - Wenzel, Sally E.
AU - Amer Thoracic Soc
AU - European Resp Soc Task Force Asthm
PY - 2009/7/1
Y1 - 2009/7/1
N2 - 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.
AB - 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.
KW - asthma control
KW - asthma exacerbations
KW - asthma severity
KW - clinical trials
KW - outcome assessment (health care)
KW - predictive value of tests
KW - EXHALED NITRIC-OXIDE
KW - QUALITY-OF-LIFE
KW - RANDOMIZED CONTROLLED-TRIAL
KW - PEAK EXPIRATORY FLOW
KW - EOSINOPHIL CATIONIC PROTEIN
KW - OBSTRUCTIVE PULMONARY-DISEASE
KW - MILD PERSISTENT ASTHMA
KW - TO-MODERATE ASTHMA
KW - HEALTH-CARE UTILIZATION
KW - INHALED FLUTICASONE PROPIONATE
U2 - 10.1164/rccm.200801-060ST
DO - 10.1164/rccm.200801-060ST
M3 - Review article
SN - 1073-449X
VL - 180
SP - 59
EP - 99
JO - American Journal of Respiratory and Critical Care Medicine
JF - American Journal of Respiratory and Critical Care Medicine
IS - 1
ER -