Purpose of the Study. Per current asthma guidelines, montelukast is considered a suitable alternative to inhaled corticosteroids (ICSs) for the treatment of mild persistent asthma, and this study was conducted to evaluate the use of oral montelukast compared with inhaled fluticasone in children with mild asthma.
Study Population. Children (aged 6–14 years) with mild persistent asthma participating in the Montelukast Study of Asthma in Children (MOSAIC) study.
Methods. In this 12-month, multicenter, randomized, double-blind, noninferiority comparison study, patients were randomly assigned to receive oral montelukast 5 mg once a day (n = 495) or inhaled fluticasone 100 μg twice a day (n = 499) after an appropriate run-in period. After baseline evaluations, patients were evaluated at 4-month intervals with spirometry and review of an asthma diary card. The primary end point, the percentage of asthma rescue-free days (RFDs), included days with no rescue-medication use and no asthma-related primary care or urgent care visits or hospitalizations. Secondary end points included forced expiratory volume in 1 second (FEV1), use of additional asthma medications, asthma attacks, β-agonist use, and peripheral blood eosinophil levels.
Results. The mean percentage of RFDs was 84% in the montelukast group compared with 86.7% in the fluticasone group. The least-squares means difference was −2.8% (95% confidence interval: −4.7% to −0.9%), which represents a difference of <1 day/month. Both montelukast and fluticasone were associated with improvement in FEV1 (percent predicted) from baseline as well as reduction in the percentage of days with β-agonist use, reduction in blood eosinophils, and improvement in patient-perceived asthma control and asthma quality-of-life scores; however, fluticasone was significantly favored in terms of FEV1, β-agonist use, asthma control, and quality of life. Montelukast was associated with the increased use of systemic corticosteroids (17.8% vs 10.5%; P ≤ .001) and a higher percentage of patients with an asthma attack (32.2% vs 25.6%) compared with fluticasone.
Conclusions. Montelukast was not inferior to fluticasone in terms of asthma RFDs; however, the use of montelukast was associated with more asthma attacks and more systemic steroid use. FEV1, β-agonist use, and quality of life improved significantly better for those in the fluticasone group.
Reviewer Comments. This study represents the first direct comparison between montelukast and an ICS measuring differences in multiple parameters of asthma control in children with mild persistent asthma. This study establishes the noninferiority of montelukast compared with fluticasone in terms of RFDs; however, in terms of FEV1, systemic corticosteroid use, number of asthma attacks and β-agonist use, fluticasone was significantly superior to montelukast. This study underscores the fact that asthma control cannot be determined with just one measure and confirms the role of montelukast as an alternative to ICSs as suggested by the current guidelines. The role of montelukast in future asthma guidelines is currently under investigation. Future studies are needed for evidence-based clinical application.
- Copyright © 2006 by the American Academy of Pediatrics