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The effect of montelukast on early‐life wheezing: A randomized, double‐blinded placebo‐controlled study
Author(s) -
Keskin Ozlem,
Arik Yilmaz Ebru,
Motzkus Christine,
Sackesen Cansin,
Lilly Craig M.,
Kalayci Omer
Publication year - 2018
Publication title -
pediatric allergy and immunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.269
H-Index - 89
eISSN - 1399-3038
pISSN - 0905-6157
DOI - 10.1111/pai.12822
Subject(s) - montelukast , medicine , placebo , salbutamol , leukotriene receptor , randomized controlled trial , placebo controlled study , anesthesia , asthma , double blind , alternative medicine , pathology
Background Cysteinyl‐leukotrienes are increased in the airways of infants with virus‐associated wheezing. We aimed to determine the effects of a cysteinyl‐leukotriene‐1 receptor antagonist on symptoms during an early‐life wheezing illness and to investigate the factors that affect the response to this drug. Method This placebo‐controlled double‐blinded randomized controlled trial recruited children aged 3‐36 months with wheezing illness and randomized to active drug or placebo for 56 days. A symptom score diary ( SSD ) was kept by the children's caregivers. Results One‐hundred patients completed the study, and 62 (30 montelukast and 32 placebo) were analyzed. There were no significant differences in the percent of symptom‐free days, symptom scores, and the need for rescue salbutamol between the two groups. However, the percent of symptom‐free days within the first week was significantly higher for the montelukast than for the placebo group (13.8 ± 4.1% vs. 5.4 ± 3.4%; P = 0.028); wheezing score at 7th day was significantly lower for the montelukast than for the placebo group (0.5 ± 0.1 vs. 1.4 ± 0.2; P = 0.002). In addition, the number of inhaled ß 2 ‐agonist rescue episodes per day during the first week was significantly lower for the montelukast compared with the placebo group (12.7 ± 1.8 vs. 19.2 ± 1.6; P = 0.013). Conclusions Our results indicate that montelukast may be effective for reducing caregiver‐observed wheezing and the need for salbutamol during the first week of treatment for early‐life wheezing. The impact for caregivers and the optimal duration of treatment will need to be explored in studies of larger size.