Montelukast Reduces Recurrent Wheezing in Infants With Bronchiolitis

Deborah Brauser

March 10, 2010

Dr. Hyo-Bin Kim

March 10, 2010 (New Orleans, Louisiana) — Infants with postrespiratory syncytial virus (RSV) bronchiolitis who are treated with montelukast (Singulair, Merck) show reduced eosinophil degranulation and fewer recurrent wheezing episodes, according to a new study from Korean investigators.

"This area is important because there is currently no exact, direct treatment for bronchiolitis; we only have indirect treatment," said Hyo-Bin Kim, MD, from the Allergy Center and Department of Pediatrics and Asthma at Inje University Paik Hospital in Seoul, Republic of Korea, during a poster presentation here at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2010 Annual Meeting.

"We think this leukotriene-receptor antagonist can have an important effect on the pathogenesis by decreasing degranulation and preventing wheezing," said Dr. Kim.

EDN Levels, Wheezing Decreased

The investigators enrolled 200 infants between the ages of 6 and 24 months. Of these, 150 who were hospitalized with their first episode of acute RSV bronchiolitis were randomized to receive either a 4 mg dose of montelukast granules (n = 79) or a matching placebo (n = 71) for 3 months. A total of 50 healthy control subjects were also enrolled in the study.

The primary end point was serum eosinophil-derived neurotoxin (EDN) levels; recurrent wheezing over 12 months was a secondary outcome.

Findings at the end of 3 months showed significantly elevated EDN levels for the placebo group (P < .0001) and significantly decreased levels for the treatment group (P < .01), "compared with their initial levels," reported Dr. Kim.

"As a result, EDN levels between the 2 groups significantly differed [P < .0001] at this point and remained so for the entire 12-month follow-up period," she added.

The treatment group also had significantly fewer cumulative recurrent wheezing episodes at 12 months (P = .039) than the placebo group.

"We think that for infants, very young infants, who suffer from RSV bronchiolitis, [this treatment] can show decreased wheezing for 1, maybe 2, years," summarized Dr. Kim. "We have to prevent the wheezing to keep it from going into asthma, which could possibly be accomplished with montelukast treatment."

She reported that the investigators hope to continue following the study patients to evaluate long-term effects.

Not Enough to Change Clinical Course

"There have been 3 [other] trials I know of that have looked at bronchiolitis treated with montelukast, with 1 of them being positive and 2 being negative," said Bradley Chipps, MD, pediatric pulmonologist and allergist at Capital Allergy & Respiratory Disease Center in Sacramento, California.

"Based on their findings, montelukast is not recommended as therapy in patients with RSV-induced bronchiolitis," he noted. "This study [presented at AAAAI] has interesting observations but it does not give a reason to use this drug in this patient population."

"It does show that there is an immunologic phenomenon that occurs but it doesn't translate into a change in the clinical course in this disease," concluded Dr. Chipps, who was not involved with the study.

This study was funded in part by grants from the Korean Research Foundation and from the Investigator-Initiated Studies Program of Merck. Dr. Kim and Dr. Chipps have disclosed no relevant financial relationships.

American Academy of Allergy, Asthma and Immunology (AAAAI) 2010 Annual Meeting: Abstract 255. Presented February 28, 2010.

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