Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5 and 15 Years of Age : a Randomised, Double-Blind, Placebo Controlled Trial
This recently published trial in Disease in Childhood journal, aimed to study the effect of the addition of a single dose of oral montelukast to standard therapy in acute moderate to severe asthma. This was a double-blind randomised controlled trial in the emergency room/outpatient paediatric services of a tertiary care hospital.
This trial included children aged 5–15 years (without prior use of montelukast) with acute moderate to severe asthma exacerbation, as defined using Modified Pulmonary Index Score (MPIS) ≥9. Children received montelukast (5–12 years: 5 mg and >12 years: 10 mg) or placebo orally in addition to the standard therapy. MPIS and forced expiratory volume in 1 second (FEV1) were recorded before administering study medication and thereafter, hourly for 4 hours.
The primary outcome was decrease in "Modified Pulmonary Index Score" to less than 9 at the end of 4 hours. The results that 117 children (60 in montelukast group and 57 in placebo group) were enrolled in the study. The number of children with decrease in MPIS to less than 9 at 4 hours was 33 (55%) in the montelukast group and 36 (63.2%) in the placebo group (p=0.37). There was significant improvement in MPIS and FEV1 within both the groups from baseline to the end of 4 hours. No differences in side effects and hospitalization rates were noticed between the two groups.
From the above findings, the authors concluded that single dose oral montelukast added to standard therapy of inhaled bronchodilators and systemic glucocorticoids did not provide additional clinical benefit in children with acute moderate to severe asthma.
REFERENCE:
Vivek Kumar Todi, Rakesh Lodha, S K Kabra. Effect of addition of single dose of oral montelukast to standard treatment in acute moderate to severe asthma in children between 5 and 15 years of age: a randomised, double-blind, placebo controlled trial. Arch Dis Child published online June 3, 2010. doi: 10.1136/adc.2009.168567
