# Pediatric Asthma: Where Has Montelukast Gone?
## 4 Montelukast in Pediatric Asthma
### School-Age Asthma  
The analysis of the literature produced in the last decade regarding montelukast application in pediatric asthma provides a quite heterogeneous picture dominated by several studies highlighting the usefulness of LTRAs as a controller option in monotherapy [94; 95; 96; 97] or as an add-on treatment [97; 98; 99; 100; 101], and, on the other hand, by evidence supporting the superiority of ICSs over montelukast (Table 2). Already a decade ago, a very rigorous Cochrane review concluded that the addition of anti-leukotrienes to ICSs was not associated with a significant reduction in the need for rescue oral corticosteroids or hospital admission compared to the same or an increased dose of ICSs in children and adolescents with mild to moderate asthma [102]. Shortly afterward, a systematic review reported that four out of eight studies found a superiority of ICSs compared with montelukast, whereas no differences between the two therapeutic regimens emerged from the others [103]. \begin{table}
\begin{tabular}{p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt}} \hline \hline
**Study** & **Age (Years)** & **No. of Patients** & **Comparison** & **Main Findings** \\ \hline [PERSON], 2021 [94] & 2–14 & 153 vs. 240 & BUD vs. MK & Lower\% of children with symptoms or need for reliever medications more than twice a week in the MK group \\ \hline [PERSON], 2019 [95] & 2–17 & 1145 vs. 1145 & BUD vs. MK & Higher adherence with MK, BUD patients more likely to have visits requiring asthma control medications \\ \hline [PERSON], 2013 [96] & 2–18 & 60 vs. 60 & BUD vs. MK & More significant improvement in FEV\({}_{1}\)/FVC and daytime symptoms in the BUD group \\ \hline [PERSON], 2014 [97] & 2–14 & 76 vs. 252 & MK vs. MK + ICSs & Significant improvement in asthma control in both groups \\ \hline [PERSON], 2022 [98] & 3–12 & 40 vs. 46 & 40 vs. 46 & Routine therapy + BUD vs. Routine therapy + BUD + MK group \\ \hline [PERSON], 2019 [99] & 7.4 \(\pm\) 2.5 & 45 vs. 45 vs. 45 & MK vs. BUD vs. BUD + MK & Improved lung function, decreased inflammatory markers, shorter symptoms disappearance time in the BUD + MK group \\ \hline [PERSON], 2015 [100] & 6–14 & 39 vs. 37 & ICSs + MK vs. ICS + placebo & Lower frequency of exacerbations, lower frequency of positive exercise challenge test in the MK group \\ \hline [PERSON], 2010 [101] & 6–17 & 165 & High dose FLUT vs. FLUT + LABA vs. FLUT + MK & LABA step-up most likely to provide the best response ( exacerbations, asthma control days, FEV\({}_{1}\)) \\ \hline \hline \end{tabular}
\end{table} 
Table 2: Studies published since 2010 comparing montelukast to other controller options in school-age asthma. These conclusions were modified a few years later, as, in the updated Cochrane review, the authors added that, for asthmatic adolescents receiving daily ICSs with suboptimal symptom control, adding anti-leukotrienes may decrease the incidence of moderate and severe exacerbations (50% reduction in the number of patients with exacerbations requiring oral corticosteroids, risk ratio 0.50, 95% CI 0.29-0.86) and improve lung function (FEV\({}_{1}\) mean change from baseline: 0.11 L, 95% CI 0.03-0.19 higher) and asthma control (asthma symptom score reduction: \(-\)0.15, 95% CI \(-\)0.26 to \(-\)0.05 lower) compared with the same dose of ICS. Nevertheless, they also stressed that available evidence did not allow them to determine whether the addition of LTRA was superior, inferior, or equivalent to a higher dose of ICSs [8]. This positive effect of montelukast seems to also extend to children with cough variant asthma, one of the most prominent causes of chronic cough in children, which manifests as an exacerbating cough, particularly in the morning and evening. Cough variant asthma, whose incidence is progressively increasing, may determine a significant impact on the learning skills, physical, and mental health of the affected children, and approximately 30-54% of cases progress toward the development of typical bronchial asthma [104].