PEDIATRICS Vol. 116 No. 2 August 2005, pp. 360-369 (doi:10.1542/peds.2004-1172)
Montelukast, Compared With Fluticasone, for Control of Asthma Among 6- to 14-Year-Old Patients With Mild Asthma: The MOSAIC Study
* Pediatric Pneumology and Allergy, Hospital Severo Ochoa Leganes, Madrid, Spain
Department of Pediatric Pneumology and Immunology, Charité, Humboldt University, Berlin, Germany
Merck and Co, Whitehouse Station and Rahway, New Jersey
Background. Guidelines recommend daily controller therapy for mild persistent asthma. Montelukast has demonstrated consistent benefit in controlling symptoms of asthma and may be an alternative, orally administered, nonsteroidal agent for treating mild asthma.
Methods. The Montelukast Study of Asthma in Children (MOSAIC study) was a 12-month, multicenter, randomized, 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 µg) (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 expiratory volume in 1 second: 87.2%; RFDs at baseline: 64%). Montelukast would be considered not inferior to fluticasone 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 montelukast 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 ß-receptor agonist use, and quality of life, improved in both groups but were significantly better in the fluticasone treatment group.
Key Words: 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
Accepted Dec 2, 2004.
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