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

Elisabeth M. W. Kooi*, Siebrig Schokker, H. Marike Boezen, Tjalling W. de Vries, Anja A. P. H. Vaessen-Verberne, Thys van der Molen, Eric J. Duiverman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

35 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)798-804
Number of pages7
JournalPulmonary Pharmacology & Therapeutics
Volume21
Issue number5
DOIs
Publication statusPublished - Oct-2008

Keywords

  • Anti-asthmatic agents
  • Fluticasone
  • Montelukast
  • Preschool
  • Child
  • Lung function
  • Interrupter technique
  • Forced oscillation technique
  • LEUKOTRIENE RECEPTOR ANTAGONIST
  • PERSISTENT CHILDHOOD ASTHMA
  • INHALED CORTICOSTEROIDS
  • RESPIRATORY RESISTANCE
  • INTERRUPTER TECHNIQUE
  • FORCED OSCILLATION
  • PEDIATRIC ASTHMA
  • LUNG-FUNCTION
  • DOUBLE-BLIND
  • AGED 2

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