There is evidence from two small randomized trials that montelukast given to children aged over 2 years with mild asthma may reduce symptoms and subsequent hospital attendance. There is no evidence for its use other than for a mild exacerbation of asthma.
- A randomized, double-blind, placebo-controlled, parallel-group study included 51 children aged 2–5 years who were using a short acting beta2-agonist intermittently and who had a clinical history of intermittent asthma [Harmanci et al, 2006]. During an acute attack the children were randomized to receive montelukast (n = 25) or placebo (n = 26). Clinical improvement was assessed by a pulmonary index score which had five parameters: air entry, wheezing, supra sternal retractions, abdominal breathing, and oxygen saturation. The score was measured at half hourly intervals for 4 hours.
- After 90 minutes there was a significant improvement in the pulmonary index score in the group receiving montelukast.
- A randomized, double-blind, placebo-controlled, multicentre trial included 220 children with intermittent asthma who were randomized to receive either montelukast (n = 107) or placebo (n = 113) during an acute exacerbation of asthma [Robertson et al, 2007]. There were 163 exacerbations of asthma over 12 months in the group receiving montelukast and 228 exacerbations in the placebo group [Robertson et al, 2007].
- There was a significant reduction in nights awakened by 8.6% (p = 0.43), days off from school by 37% (p< 0.0001), and parent time off from work by 33% (p<0.0001).
- A randomized, double-blind, placebo-controlled, pilot study enrolled children aged 6–14 years who presented with an acute asthma exacerbation of moderate severity (PEFR = 40–70% of predicted) [Nelson et al, 2008]. The children were randomized to receive either oral montelukast or placebo at the beginning of their treatment. FEV1 was measured before the start of treatment and then hourly until 3 hours post treatment.
- There was no improvement in FEV1 at 3 hours.
- The authors concluded that in children with moderate asthma, oral montelukast is unlikely to result in improvement in FEV1.