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JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
Responses to bronchial challenge submitted for approval to use inhaled beta2-agonists before an event at the 2002 Winter Olympics.
Journal of Allergy and Clinical Immunology 2003 January
BACKGROUND: There has been an increase in the number and percentage of athletes competing in Olympic Games notifying use of beta2-agonists, from 1.7% at Los Angeles (1984) to 5.5% at Sydney (2000). For Salt Lake City (2002), the International Olympic Committee requested objective evidence to use beta2-agonists for asthma or exercise-induced asthma (EIA).
OBJECTIVE: The objective of this study was to evaluate the evidence submitted for approval to use a beta2-agonist.
METHODS: Objective evidence for asthma or EIA included (1) an increase of 12% or more of the predicted FEV1 in response to bronchodilator, (2) a reduction in FEV1 of 10% or greater from baseline in response to exercise or eucapnic voluntary hyperpnea, (3) a PD20 FEV1 to methacholine or histamine at a dose of less than 200 microg (2 mg/mL) or less than 1320 microg (13.2 mg/mL) for those taking inhaled corticosteroids for 3 months.
RESULTS: There were 165 applications. Of these, 147 (89%) included evidence of a challenge, bronchodilator response, or both, and 163 test results were submitted. One hundred thirty (5.2%) applications were approved. For those with positive responses, the median value (1) was 16.2% of predicted FEV1 for response to a bronchodilator (n = 13), (2) was a 15.9% decrease in FEV1 for response to a physical challenge (n = 36), and, (3) for PD20 FEV1, was 173 microg for response to a pharmacologic challenge (n = 45).
CONCLUSION: The analysis demonstrated that it is feasible to request objective evidence to justify use of beta2-agonists on the medical grounds of asthma or EIA.
OBJECTIVE: The objective of this study was to evaluate the evidence submitted for approval to use a beta2-agonist.
METHODS: Objective evidence for asthma or EIA included (1) an increase of 12% or more of the predicted FEV1 in response to bronchodilator, (2) a reduction in FEV1 of 10% or greater from baseline in response to exercise or eucapnic voluntary hyperpnea, (3) a PD20 FEV1 to methacholine or histamine at a dose of less than 200 microg (2 mg/mL) or less than 1320 microg (13.2 mg/mL) for those taking inhaled corticosteroids for 3 months.
RESULTS: There were 165 applications. Of these, 147 (89%) included evidence of a challenge, bronchodilator response, or both, and 163 test results were submitted. One hundred thirty (5.2%) applications were approved. For those with positive responses, the median value (1) was 16.2% of predicted FEV1 for response to a bronchodilator (n = 13), (2) was a 15.9% decrease in FEV1 for response to a physical challenge (n = 36), and, (3) for PD20 FEV1, was 173 microg for response to a pharmacologic challenge (n = 45).
CONCLUSION: The analysis demonstrated that it is feasible to request objective evidence to justify use of beta2-agonists on the medical grounds of asthma or EIA.
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