NEW YORK (Reuters Health) – Neither the frequency nor the duration of upper respiratory infections (URIs) in preschoolers are reduced by prophylactic treatment with montelukast, according to the results of placebo-controlled trial conducted in Israel.
There were no significant differences between the groups in the number of unscheduled medical appointments or in the number of days parents missed work because their child suffered from URI,” the researchers report in the February issue of Pediatrics.
Dr. Eran Kozer, at Assaf Harofeh Medical Center in Zerifin, Israel, and colleagues point out that viral URIs increase the level of leukotrienes in nasal secretions, and that treatment of adult asthma patients with a leukotriene-receptor antagonist has been associated with reduced incidence of common cold-like symptoms.
Noting that there are no preventive measures for URIs currently, the investigators tested the hypothesis that prophylactic treatment with the selective leukotriene-receptor antagonist montelukast might reduce the incidence and severity of URIs in children.
They randomly assigned 300 healthy children aged 1 to 5 years to receive 12 weeks of treatment with 4 mg oral montelukast or a matching placebo. Parents were given a diary card to record any acute URI symptoms, and they were contacted weekly for relevant information.
The 12-week study was completed by 131 children in the montelukast group and 129 of those given placebo. The number of reported URI episodes during the study period in the two groups was 2.7 versus 2.4 , respectively, (p=0.14), the authors found, and the duration of URI episodes was 7.4 versus 6.1 days, respectively, (p=0.37).
Dr. Kozer and colleagues point out several limitations to their study, including the possibility that the sample size affected the results. “However,” they conclude, “because there was no trend for better outcome with montelukast, it is unlikely that a larger sample would have shown significant benefits for the drug.”
SOURCE:
RCT of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children
Pediatrics 2012;129.
