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Fluticasone or montelukast for preschool children with asthma-like symptoms: Randomized controlled trial.

Author(s): Kooi EM, Schokker S, Marike Boezen H, de Vries TW, Vaessen-Verberne AA, van der Molen T, Duiverman EJ

Affiliation(s): Department of Pediatrics, Division of Pediatric Pulmonology and Allergology, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, P.O. Box 196, 9700 AD Groningen, The Netherlands. emwkooi@hotmail.com

Publication date & source: 2008-10, Pulm Pharmacol Ther., 21(5):798-804. Epub 2008 Jul 2.

Publication type: Research Support, Non-U.S. Gov't

RATIONALE: Beneficial effects of anti-inflammatory therapy such as fluticasone propionate (FP) and montelukast (Mk) have been demonstrated in preschool children with asthma. However, comparative studies are lacking in this age group. Therefore, we conducted a study to evaluate and compare the effect of FP and Mk in preschool children with asthma-like symptoms. METHODS: In this multicenter, randomized, placebo-controlled, double-blind, double-dummy trial, children aged 2-6 years with asthma-like symptoms were included. In total, 63 children were randomly allocated to receive FP (25), Mk (18) or placebo (20) for 3 months. The primary outcome was the daily symptom score (wheeze, cough, shortness of breath) as recorded by caregivers in a symptom diary card. Secondary endpoints were rescue medication free days, blood eosinophils and lung function (interrupter technique and forced oscillation technique (FOT)). RESULTS: During the 3 months study period, symptoms improved in all 3 groups, with a statistically significant difference between FP and placebo in favor of the FP group (p=0.021). A significant reduction in circulating eosinophils after 3 months of treatment was found in the Mk group only (p=0.008), which was significantly different from the change found in the placebo group (p=0.045). With the exception of frequency dependence (measured by FOT), which showed a difference between FP and Mk after 3 months of treatment in favor of the FP group (p=0.048), no differences in lung function within or between groups were found. CONCLUSIONS: In spite of a lack of power, our results suggest that FP has a beneficial effect on symptoms and Mk on blood eosinophil level as compared to placebo. Except for a difference in one lung function parameter after 3 months between FP and Mk in favor of the FP group, this study revealed no differences between FP and Mk.

Page last updated: 2008-11-03

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