Fluticasone or montelukast for preschool children with asthma-like symptoms: Randomized controlled trial.
BACKGROUND
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.
Kooi
Elisabeth M W
EM
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
Schokker
Siebrig
S
Marike Boezen
H
H
de Vries
Tjalling W
TW
Vaessen-Verberne
Anja A P H
AA
van der Molen
Thys
T
Duiverman
Eric J
EJ
D000085:Acetates / Q000008:administration & dosage / Q000627:therapeutic use*; D000284:Administration, Oral; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002675:Child, Preschool; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D009426:Netherlands; D010044:Outpatient Clinics, Hospital; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D012129:Respiratory Function Tests / Q000379:methods; D013440:Sulfides; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome
D000085:Acetates; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D013607:Tablets; D000068298:Fluticasone; C093875:montelukast