Szefler SJ, Baker JW, Uryniak T, Goldman M, Silkoff PE. J Allergy Clin Immunol. 2007;120(5):1043–1050
PURPOSE OF THE STUDY. To evaluate the efficacy of budesonide inhalation suspension (Pulmicort respules) compared with montelukast (Singulair) for controlling asthma symptoms in young children with mild persistent asthma.
STUDY POPULATION. This was a prospective study of 395 children, aged 2 to 8 years, diagnosed with mild persistent asthma recruited from 55 US centers. Approximately 12% of the subjects had previous histories of inhaled corticosteroid (ICS) use.
METHODS. Subjects were randomly assigned to receive either budesonide 0.5 mg or montelukast 4 to 5 mg daily and were followed for 52 weeks. Compliance was assessed by daily electronic diary review. For mild asthma exacerbations, step-up therapy consisted of the addition of a morning dose of budesonide 0.5 mg in both arms. For severe asthma exacerbations, subjects received a 3- to 10-day standardized course of oral steroids. The primary end point was evaluated by using the intention-to-treat population and was defined as time to first additional medication for asthma worsening at 52 weeks. Secondary end points included the time to additional asthma medication and rates of occurrence of mild and severe asthma exacerbations. Changes in symptom scores, peak flows, rescue-medication use, and pulmonary-function test results were also evaluated.
RESULTS. Kaplan-Meier probability curves showed that the primary outcome measurement, time to the first additional asthma medication, was not significantly different between the 2 groups at 52 weeks (P = .3). There was a significant increase in the time to first additional asthma medication in the budesonide group compared with the montelukast group at 12 weeks (P = .05). The percentage of subjects requiring step-up therapy in the budesonide group versus the montelukast group at 12 weeks was 29.1% versus 38.6% (not significant [NS]), at 26 weeks was 41.3% versus 48.2% (NS), and at 52 weeks was 52% versus 56.9% (NS), respectively. The budesonide group achieved significantly improved morning and evening peak flow values compared with the montelukast group at 12 weeks (P = .005–.007). The rate of mild and severe asthma exacerbations per subject per year in the budesonide and montelukast groups was 1.23 and 1.63, respectively (P = .034). There was no significant difference in the number of severe asthma exacerbations between the 2 groups. Both treatment groups showed nonsignificant improvements in changes from baseline asthma scores, 24-hour rescue-medication use, and medication- and asthma-free days.
CONCLUSIONS. Both budesonide and montelukast are effective and well-tolerated as controller medications in children aged 2 to 8 years with mild persistent asthma. Results favored budesonide for several secondary outcome measures.
REVIEWER COMMENTS. Previous studies have shown that ICSs are more effective asthma-controller medications compared with montelukast in children older than 6 years. Although this study failed to show statistical significance in the primary outcome, it provides data supporting certain treatment benefits of ICSs in children younger than 6 years (257 of 395 children were <5 years old). Compared with previous studies, these children had milder asthma, with only 12% having taken ICSs before enrollment.
- Copyright © 2008 by the American Academy of Pediatrics