In children between 3 and 36 months of age, the use of montelukast therapy decreased wheezing scores and reduced the need for inhaled beta-2-agonist medication in the first weeks of a recurrent wheezing illness, according to the results of a recent prospective, placebo-controlled, double-blind, randomized, controlled trial (ClinicalTrials.gov identifier: NCT00115297) published in Pediatric Allergy and Immunology.
Infants and young children between 3 and 36 months of age with wheezing qualified for the analysis if they were diagnosed by a physician as having a wheezing illness of sufficient severity to require close observation, the use of oxygen, or medical treatment for the wheezing episode. Study participants were randomly assigned to treatment with montelukast or placebo for 56 days. A total of 100 patients completed the study; 62 (montelukast, n=30; placebo, n=32) were analyzed.
The primary study outcome was the number of symptom-free days. A symptom score diary was maintained by the children’s caregivers in which they recorded daytime and nighttime scores for wheezing, coughing, and dyspnea on a scale of 0 (no symptoms) to 4 (very severe symptoms). The number of beta-2-rescue treatments administered was also recorded.
No significant differences were reported between the 2 groups in the percentage of symptom-free days, symptom scores, and the need for rescue salbutamol. Within the first week, however, the percentage of symptom-free days was significantly higher in the montelukast arm vs the placebo arm (13.8%±4.1% vs 5.4%±3.4%, respectively; P =.028). On day 7, the wheezing score was significantly lower in the montelukast group than in the placebo group (0.5±0.1 vs 1.4±0.2, respectively; P =.002). Moreover, the number of inhaled beta-2-agonist rescue episodes per day over the first week was significantly lower with montelukast treatment compared with placebo (12.7±1.8 vs 19.2±1.6, respectively; P =.013).
The investigators concluded that the use of montelukast in the first weeks of a recurrent wheezing illness in the 3- to 36-month age group decreased patients’ wheezing scores and reduced the need for rescue medication.
Additional studies are warranted to better define “the importance of wheezing episodes and burden of beta-2-agonist rescue events to caregivers,” and to more clearly elucidate the optimal duration of montelukast therapy.
Keskin O, Arik Yilmaz E, Motzkus C, Sackesen C, Lilly CM, Kalayci O. The effect of montelukast on early life wheezing: a randomized, double-blinded placebo-controlled study [published online October 19, 2017]. Pediatr Allergy Immunol. doi:10.1111/pai.12822