PEDIATRICS Vol. 104 No. 2 Supplement August 1999, pp. 392
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Purpose of the Study To determine the clinical effect of oral montelukast sodium, a leukotriene receptor antagonist, in asthmatic patients aged 15 years or more.
Study Population
Fifty clinical centers randomly allocated 681 patients with chronic,
stable asthma to receive placebo or montelukast after demonstrating a
forced expiratory volume in 1 second (FEV1) 50% to 85% of
the predicted value, at least a 15% improvement FEV1 (absolute value) after inhaled
-agonist administration, a minimal predefined level of