Abstract

Background: Limited clinical data are available on the long-term effects of asthma controller therapy on the utilization of health care resources in pediatric patients with asthma. Objective: The objective of this study was to compare the effects of long-term treatment with montelukast andusual care on health care resource use in children with asthma. Methods: Pediatric patients aged 2 to 5 years with asthma who had completed a 3-month, double-blind, double-dummyclinical trial comparing montelukast 4 mg and placebo were asked to participate in an open-label, controlled extension study comparing montelukast 4 mg and usual care. Usual care was defined as cromolyn or inhaled corticosteroid therapy Health care resource utilization was measured in terms of oral corticosteroid use and numbers of physician visits, emergency department visits, and hospitalizations. Results: Of 618 patients who completed the primary phase of the study, 516 (83.5%) participated in the extension study Data from 506 patients (302 without previous asthma maintenance therapy, 204 with) were included in the analysis. During the extension phase, patients who received montelukast and had not used previous asthma maintenance therapy were followed for a mean of 329.5 days; those who received usual care and Conclusion: In this open-label study, pediatric patients aged 2 to 5 years with mild to moderate persistentasthma receiving long-term therapy with montelukast had similar rates of asthma-related health care resource utilization compared with those receiving usual care with cromolyn or inhaled corticosteroids.

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