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.
OBJECTIVE
To study the effect of the addition of a single dose of oral montelukast to standard therapy in acute moderate to severe asthma.


METHODS
Double-blind randomised controlled trial. Setting Emergency room/outpatient paediatric services of a tertiary care hospital.


METHODS
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) > or =9, were enrolled.


METHODS
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 (FEV(1)) were recorded before administering study medication and thereafter, hourly for 4 hours.


METHODS
The primary outcome was decrease in MPIS to less than 9 at the end of 4 hours.


RESULTS
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 FEV(1) within both the groups from baseline to the end of 4 hours. No differences in side effects and hospitalisation rates were noticed between the two groups.


CONCLUSIONS
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. Trial registration number The trial was registered at the http://clinicaltrials.gov site (trial ID: NCT00565955).
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110029, India.
Vivek Kumar
VK
Todi
Rakesh
R
Lodha
S K
SK
Kabra
D000085:Acetates / Q000008:administration & dosage* / Q000627:therapeutic use; D000284:Administration, Oral; D000293:Adolescent; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D003521:Cyclopropanes; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D011804:Quinolines / Q000008:administration & dosage* / Q000627:therapeutic use; D012720:Severity of Illness Index; D013440:Sulfides
D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast