Singulair Doesn't Ease Wheeze in Most Kids

Intermittent montelukast (Singulair) didn't alleviate wheezing in children, except possibly for those with a specific genetic mutation, a trial showed.

Giving the leukotriene receptor blocker at the onset of wheezing didn't cut down on unscheduled medical visits for those episodes compared with placebo (mean 2.0 versus 2.3 over 12 months, incidence rate ratio 0.88, P=0.06), Jonathan Grigg, MD, of the Queen Mary University of London, and colleagues found.

However, the subgroup of children with the 5/5 ALOX5 promoter genotype associated with montelukast response in adults did have a 20% relative reduction in unscheduled wheeze-related medical visits with the drug (2.0 versus 2.4 over 12 months, P=0.01).

No effect was seen with other genotypes (P=0.79), the researchers reported at the European Respiratory Society meeting in Munich and simultaneously online in the Lancet Respiratory Medicine.

"These data do not support the routine use of intermittent montelukast for wheeze in children aged 10 months to 5 years," the group concluded. "Further data from stratified trials are needed before treatment is targeted to a responsive subgroup."

Their Wheeze And Intermittent Treatment (WAIT) trial included 1,358 children in the age range of 10 months to 5 years, who were seen at 21 primary care sites and 41 secondary care sites in England and Scotland. They had two or more wheeze episodes (at least one recent).

After stratification by genotype, the kids were randomized to montelukast or placebo given by parents at each wheeze episode over a 12-month period.

Overall, montelukast increased the time to first hospital admission (P=0.04) but without changing the rate of emergency department visits.

Also, montelukast-treated kids received fewer courses of rescue oral corticosteroids, but without reducing the proportion of children getting at least one course of those rescue meds.

And, "in the context of present U.K. prescribing practice, the clinical significance of a change in this indirect marker of wheeze severity is unclear," the researchers cautioned.

The number and duration of wheeze episodes didn't differ between treatment groups.

The only serious adverse event -- a skin reaction -- occurred in the placebo group.

Meta-analysis of the findings of those of three prior trials of montelukast in young children, yielded results similar to those of the trial by Grigg and colleagues, supporting no overall benefit from intermittent dosing.

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