Pilot study of oral montelukast added to standard therapy for acute asthma exacerbations in children aged 6 to 14 years.
OBJECTIVE
We hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast with standard therapy will have at least 12% greater forced expiratory volume in 1 second (FEV1) improvement in 3 hours than those receiving standard therapy alone.


METHODS
In this randomized, double-blind, placebo-controlled study, we enrolled emergency patients aged 6 to 14 years with moderate acute asthma exacerbations (peak expiratory flow rate, 40%-70% predicted). Subjects received montelukast 5 mg or placebo orally then standard therapy. We measured FEV1 before study medication administration and hourly for 3 hours. The primary outcome was FEV1% predicted change at 3 hours.


RESULTS
At the time of the planned interim analysis, we had enrolled 27 subjects; 23 (11 montelukast, 12 placebo) had a complete FEV1 data. Both groups had similar mean FEV1 increases at 3 hours (mean [SD]: montelukast = 16.8% [11.4%], placebo = 19.9% [12.1%]; 95% confidence interval for difference = -12.22% to 5.95%). Based on further analysis, we determined that enrollment of the planned sample was unlikely to significantly change the results. If our study hypothesis were true, the montelukast group mean FEV1 increase should be 32% or greater. The probabilities were low that the montelukast sample could be drawn from a normally distributed population with a mean of 32% and that subsequently enrolled montelukast subjects would have sufficient FEV1 improvements to attain a mean of greater than 32%.


CONCLUSIONS
Based on these results, for children aged 6 to 14 years with moderate acute asthma exacerbations, oral montelukast (5 mg) added to standard therapy as in this design is unlikely to result in additional FEV1 improvements in 3 hours.
Nelson
Kyle A
KA
Division of Emergency Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, MO, USA. nelsonk@email.chop.edu
Smith
Sharon R
SR
Trinkaus
Kathryn
K
Jaffe
David M
DM
D000085:Acetates / Q000008:administration & dosage*; D000284:Administration, Oral; D000293:Adolescent; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000175:diagnosis* / Q000188:drug therapy*; D002648:Child; D016001:Confidence Intervals; D003521:Cyclopropanes; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011336:Probability; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage*; D012008:Recurrence; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast