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Intermittent montelukast for children with wheeze produced no clear benefit

Intermittent montelukast in young children with wheeze showed no significant benefit when compared with placebo, according to study results.

Researchers conducted a parallel-group, randomized trial between October 2010 and December 2013 at 21 primary care sites and 41 secondary care sites in England and Scotland. There were 1,358 children aged 10 months to 5 years with two or more wheeze episodes allocated to receive a 5/5 or 5/x+x/x arachidonate 5-lipoxygenase (ALOX5) gene promoter “then randomly assigned (1:1) via a permuted block schedule (size ten), to receive intermittent montelukast [n=669] or placebo [n=677] … at each wheeze episode over a 12-month period.”

The number of unscheduled medical visits for wheezing episodes was the primary outcome, with analysis by intention to treat.

Primary outcome data was available for 96% of the cohort. The mean unscheduled medical visits for wheezing episodes were not significantly different between the montelukast- and placebo-treatment cohorts (2 vs. 2.3; incident rate ratio=0.88; 95% CI, 0.77-1.01). Patients assigned montelukast in the 5/5 stratum had reduced unscheduled medical visits for wheezing episodes compared with placebo-treated children (2 vs. 2.4; IRR=0.8; 95% CI, 0.68-0.95). Patients in the 5/x+x/x stratum, however, did not have reduced unscheduled medical visits when compared with placebo-treated children (2 vs. 2; IRR=1.03; 95% CI, 0.83-1.29). One child receiving placebo treatment experienced a skin reaction, the only serious adverse event recorded.

“These data do not support the routine use of intermittent montelukast for wheeze in children aged 10 months to 5 years,” the researchers concluded. “However, the 5/5 ALOX5 promoter genotype might identify a montelukast-responsive subgroup. Further stratified trials should be done to confirm the presence of a responsive subgroup.”

Disclosure: See the study for a full list of relevant financial disclosures.