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Montelukast not associated with decreased URIs

Kozer E. Pediatrics. 2012;doi:10.1542/peds.2011-0358.

Twelve weeks of treatment with 4 mg of the selective leukotriene receptor antagonist montelukast failed to help in preventing upper respiratory infections when compared with placebo, according to a study published online.

Eran Kozer, MD, of the pediatric emergency unit at the Assaf Harofeh Medical Center in Zerifin, Israel, tested prophylactic montelukast (Singulair, Merck) in 300 healthy children aged 1 to 5 years who were seen in three ambulatory care clinics in Israel. But in parent reports, the number of weeks that upper respiratory infections (URIs) were reported was similar between the two groups — 30.4% for children treated with montelukast and 30.7% for children treated with placebo (P=.83).

The researchers also found that the number of days the children were assigned antibiotics and the rate of fever episodes were actually prolonged in the prophylactic group. They reported a low rate of adverse events in both groups.

The researchers noted some study limitations, including that only about 33% of the parents in the group completed a full 12 weeks of the diary, which they used to log illnesses, but they said regardless of this limitation, the rates were similar in both groups.

Disclosure: The study was funded in part by Merck Sharp & Dohme, Israel, and some researchers reported working for this company.

It is no news that upper respiratory infections (URI) pose a major problems to the community, no matter whether dealing with children or adults. Still, the scale is impressive: In fall and winter, cold symptoms are experienced by one child out of four, the illness duration is at least a week, and in the US, annually up to 2 million visits to emergency departments occur because of URI. Therefore, there is a great need to explore almost anything which comes to mind to prevent and treat this commonplace scourge. An Israeli study group looked if montelukast (Singulair, Merck), a leukoktriene-receptor antagonist and well-known agent in asthma an allergic rhinitis, would affect the number and duration of URI episodes in children at age 1 to 5 years. The rationale was that since the concentration of lipid mediators of inflammation, leukotrienes, increases in viral infections such as those due to RSV and influenza, perhaps their inhibition would decrease URIs. In all, 153 and 147 children were randomly assigned to receive daily 4 mg of oral montelukast or placebo, respectively, for 12 weeks. The mean age in both groups was 3 years, and the characteristics of the children were very similar.

The parents were asked to fill diaries, but they did adequately so only in about 35%. Regular telephone interviews gave, however, pretty reliable information of how things proceeded. The end result was that montelukast did not work in the sense the investigators had hypothesized; parents reported 30.7 and 30.4 episodes of URI in the montelukast and the placebo group, respectively.

The negative result is hardly a surprise. In fact, I wonder why montelukast (or any other leukoktriene-receptor antagonist) was expected to prevent or ameliorate viral infections. This said, the investigators must be congratulated of their well-conducted study. We remain awaiting other ideas to combat our mutual foe.

Heikki Peltola, MD
Infectious Diseases in Children Editorial Board member

Disclosure: Dr. Peltola reports no relevant financial disclosures.

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