Montelukast, Compared With Fluticasone, for Control of Asthma Among 6- to 14-Year-Old Patients With Mild Asthma: The MOSAIC Study

Background. Guidelines recommend daily controller therapy for mild persistent asthma. Mon- telukast has demonstrated consistent benefit in control- ling symptoms of asthma and may be an alternative, orally administered, nonsteroidal agent for treating mild asthma. Methods. The Montelukast Study of Asthma in Chil- dren (MOSAIC study) was a 12-month, multicenter, ran- domized, double-blind, noninferiority trial to determine the effect of once-daily, orally administered montelukast (5 mg) (n 495), compared with twice-daily, inhaled fluticasone (100 g) (n 499), on the percentage of asthma rescue-free days (RFDs) (any day without asthma rescue medication and with no asthma-related resource use). Patients 6 to 14 years of age had mild persistent asthma (average percentage of predicted forced expira- tory volume in 1 second: 87.2%; RFDs at baseline: 64%). Montelukast would be considered not inferior to flutica- sone if the upper limit of the 95% confidence interval for the difference in mean percentages of RFDs (fluticasone minus montelukast) was above 7% (a difference of 2 days/month). Results. The mean percentage of RFDs was 84.0% in the montelukast group and 86.7% in the fluticasone group. The least-squares mean difference was 2.8% (95% confidence interval: 4.7% to 0.9%), within the noninferiority limit of 7%. The proportion of patients requiring systemic corticosteroids and the number of patients with an asthma attack were greater in the mon- telukast group. Both montelukast and fluticasone were well tolerated. Conclusions. Montelukast was demonstrated to be not inferior to fluticasone in increasing the percentage of RFDs among 6- to 14-year-old patients with mild asthma. Secondary end points, including percentage of predicted forced expiratory volume in 1 second value, days with -receptor agonist use, and quality of life, improved in both groups but were significantly better in the flutica- sone treatment group. Pediatrics 2005;116:360-369; asthma, asthma control, inhaled corticosteroid, safety, randomized controlled trial. ABBREVIATIONS. FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroids; GINA, Global Initiative for Asthma; ANCOVA, analysis of covariance; CI, confidence interval; RFD, rescue-free day.