Attenuation of the September epidemic of asthma exacerbations in children: a randomized, controlled trial of montelukast added to usual therapy.
BACKGROUND
A recurring epidemic of asthma exacerbations in children occurs annually in September in North America when school resumes after summer vacation.


OBJECTIVE
Our goal was to determine whether montelukast, added to usual asthma therapy, would reduce days with worse asthma symptoms and unscheduled physician visits of children during the September epidemic.


METHODS
A total of 194 asthmatic children aged 2 to 14 years, stratified according to age group (2-5, 6-9, and 10-14 years) and gender, participated in a double-blind, randomized, placebo-controlled trial of the addition of montelukast to usual asthma therapy between September 1 and October 15, 2005.


RESULTS
Children randomly assigned to receive montelukast experienced a 53% reduction in days with worse asthma symptoms compared with placebo (3.9% vs 8.3%) and a 78% reduction in unscheduled physician visits for asthma (4 [montelukast] vs 18 [placebo] visits). The benefit of montelukast was seen both in those using and not using regular inhaled corticosteroids and among those reporting and not reporting colds during the trial. There were differences in efficacy according to age and gender. Boys aged 2 to 5 years showed greater benefit from montelukast (0.4% vs 8.8% days with worse asthma symptoms) than did older boys, whereas among girls the treatment effect was most evident in 10- to 14-year-olds (4.6% [montelukast] vs 17.0% [placebo]), with nonsignificant effects in younger girls.


CONCLUSIONS
Montelukast added to usual treatment reduced the risk of worsened asthma symptoms and unscheduled physician visits during the predictable annual September asthma epidemic. Treatment-effect differences observed between age and gender groups require additional investigation.
Johnston
Neil W
NW
Firestone Institute for Respiratory Health, St Joseph's Healthcare, 50 Charlton Ave E, Hamilton, Ontario, Canada L8N 4A6. njohnsto@mcmaster.ca
Mandhane
Piush J
PJ
Dai
Jennifer
J
Duncan
Joanne M
JM
Greene
Justina M
JM
Lambert
Kim
K
Sears
Malcolm R
MR
D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D000367:Age Factors; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D003139:Common Cold / Q000453:epidemiology; D003521:Cyclopropanes; D004196:Disease Outbreaks / Q000517:prevention & control*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D009819:Office Visits / Q000706:statistics & numerical data; D009864:Ontario / Q000453:epidemiology; D011804:Quinolines / Q000627:therapeutic use*; D012574:Schools; D012621:Seasons; D012720:Severity of Illness Index; D012737:Sex Factors; D013440:Sulfides; D011795:Surveys and Questionnaires
D000085:Acetates; D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast