Purpose of the Study. The possible additive effects of leukotriene antagonists and inhaled corticosteroids have not been studied in children. This study sought to determine whether the addition of montelukast to budesonide would improve asthma control in children with inhaled glucocorticoid-dependent persistent asthma.
Study Population. A total of 279 children with asthma with persistent asthma on inhaled corticosteroid therapy.
Methods. This was a multicenter, randomized, double-blind, crossover study. After a 1-month run-in on budesonide 200 μg twice daily, children were randomized to receive montelukast 5 mg daily or placebo over the next 4 weeks, after which they were crossed-over to the opposite treatment for the next 4 weeks.
Results. The mean age was 10.4 ± 2.2 years, the mean forced expiratory volume in 1 second (FEV1) was 77.7% ± 10.6% predicted, and reversibility was 18.1% ± 12.9%. Compared with adding placebo to budesonide, adding montelukast produced significant improvements in the mean percent change from baseline FEV1 (P = .062 [P = .010 for per-protocol analysis]), mean absolute change from baseline FEV1 (P = .040), mean increase from baseline in morning (P = .023) and evening (P = .012) peak expiratory flows, decrease in exacerbation days by approximately 23% (P < .001), decreased β2-agonist use (P = .013), and reduced blood eosinophil counts (P < .001). There were no significant differences with regard to safety.
Conclusion. The addition of montelukast to budesonide improved asthma control significantly, with improvements in lung function, symptoms, and the need for rescue medication.
Reviewer’s Comments. Although a relatively short-term study, the data provided here clearly support the additive effect of montelukast and budesonide. This may allow for the use of lower steroid doses to achieve the same level of asthma control.
- Copyright © 2002 by the American Academy of Pediatrics