In school-age children and adolescents with mild to moderate persistent asthma, inhaled corticosteroid (ICS) therapy gives better outcomes than oral montelukast according to a meta-analysis, but there is inadequate evidence to determine whether combination treatment is better.

Asthma is common in school-age children and adolescents, and guidelines recommend ICS as first-line therapy with a leukotriene receptor antagonist (LTRA) as an alternative. Meta-analyses published in 2004 suggested that ICS was a more effective option and that adding LTRA gave modest improvements. These were based on very limited data, however: as further trials have been published since, the authors aimed to update the original work. As montelukast is the most used LTRA, only trials involving this drug were included.

They carried out a comprehensive literature search for randomised controlled trials in children aged under 18 years who had confirmed mild to moderate asthma; eligibility criteria included comparison of ICS with montelukast alone or combined with ICS, treatment duration of at least four weeks aith stable dosage, and use of asthma exacerbations requiring systemic corticosteroid as a primary outcome (as this was the intended primary outcome for the meta-analysis). Lung function measurements, adverse effects, etc. were included as secondary outcomes.

The initial search yielded 124 potentially relevant papers, of which 87 were retrieved for further assessment: after exclusions, 18 (n=3,757) were available for analysis (main reasons for ineligibility were not reporting specified outcomes, use of other LTRA, or too short). Most (13) compared ICS with montelukast, three compared ICS with ICS plus montelukast, and two were three-arm studies comparing with ICS only, montelukast only, and ICS plus montelukast arms. Mean patient age was 9.7 years and only one study included children under 8 (age range 2 to 8). Six lasted >24 weeks, and methodological quality (by Jadad score) ranged from 3 to 5 (eight scored 4 or 5).

Overall, patients treated with ICS had a lower risk of acute exacerbations (RR=0.83; 95% CI= 0.72 to 0.96; p=0.01) compared to those treated with montelukast. Secondary outcomes also favoured ICS in comparison to montelukast. Combination of ICS with montelukast was not significantly better than ICS alone, however this was based on only two studies and the 95% CI were wide (RR=0.53; 95% CI= 0.1 to 2.74; p=0.45) with evidence of statistical heterogeneity.

The authors conclude that on current evidence, treatment with ICS is associated with better outcomes in school-age children and adolescents who have mild to moderate persistent asthma compared to treatment with montelukast. In particular, there is a reduced risk of exacerbations, which have the greatest impact on healthcare utilisation, healthcare costs, and lost school days in this group.  There is not enough evidence to determine whether combination of ICS and montelukast improves outcomes and further studies are needed to clarify this issue.