The effect of montelukast on early-life wheezing: A randomized, double-blinded placebo-controlled study.

Abstract

BACKGROUND:

Cysteinyl-leukotrienes are increased in the airways of infants with virus-associated wheezing. We aimed to determine the effects of a cysteinyl-leukotriene-1 receptor antagonist on symptoms during an early-life wheezing illness and to investigate the factors that affect the response to this drug.

METHOD:

This placebo-controlled double-blinded randomized controlled trial recruited children aged 3-36 months with wheezing illness and randomized to active drug or placebo for 56 days. A symptom score diary (SSD) was kept by the children's caregivers.

RESULTS:

One-hundred patients completed the study, and 62 (30 montelukast and 32 placebo) were analyzed. There were no significant differences in the percent of symptom-free days, symptom scores, and the need for rescue salbutamol between the two groups. However, the percent of symptom-free days within the first week was significantly higher for the montelukast than for the placebo group (13.8 ± 4.1% vs. 5.4 ± 3.4%; P = 0.028); wheezing score at 7th day was significantly lower for the montelukast than for the placebo group (0.5 ± 0.1 vs. 1.4 ± 0.2; P = 0.002). In addition, the number of inhaled ß2 -agonist rescue episodes per day during the first week was significantly lower for the montelukast compared with the placebo group (12.7 ± 1.8 vs. 19.2 ± 1.6; P = 0.013). Conclusions Our results indicate that montelukast may be effective for reducing caregiver-observed wheezing and the need for salbutamol during the first week of treatment for early-life wheezing. The impact for caregivers and the optimal duration of treatment will need to be explored in studies of larger size.

• Authors: Ozlem Keskin, Ebru Arik Yilmaz, Christine Motzkus, Cansin Sackesen, Craig M Lilly, Omer Kalayci
• Journal: Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology (Pediatr Allergy Immunol) Vol. 29 Issue 1 Pg. 50-57 (02 2018) ISSN: 1399-3038 [Electronic] England
• PMID: 29047178 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: © 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

Chemical References

• Acetates
• Anti-Asthmatic Agents
• Cyclopropanes
• Eicosanoids
• Quinolines
• Sulfides
• montelukast

Topics

• Acetates (adverse effects, therapeutic use)
• Anti-Asthmatic Agents (adverse effects, therapeutic use)
• Child, Preschool
• Cyclopropanes
• Double-Blind Method
• Eicosanoids (metabolism)
• Female
• Humans
• Infant
• Male
• Prospective Studies
• Quinolines (adverse effects, therapeutic use)
• Respiratory Sounds (drug effects)
• Sulfides
• Treatment Outcome