The Back to School asthma study: the effect of montelukast on asthma burden when initiated prophylactically at the start of the school year.
BACKGROUND
Pediatric asthma hospitalizations peak in early autumn.


OBJECTIVE
To determine the effectiveness of montelukast therapy in reducing the asthma burden in children when initiated prophylactically on school return.


METHODS
This was a randomized, multicenter, double-blind, placebo-controlled study of children with asthma aged 6 to 14 years. No minimum asthma symptoms were required, and patients could continue inhaled corticosteroid (ICS) use. Montelukast, 5 mg, chewable tablet (n = 580) or matching placebo (n = 582) was taken the night before the first day of school and nightly thereafter for 8 weeks. The primary end point was the percentage of days with worsening asthma, defined by one of the following: (1) increased beta-agonist use, (2) increased daytime symptoms, (3) awake "all night," (4) oral corticosteroid rescue or increased ICS use for worsening asthma, or (5) unanticipated health care utilization.


RESULTS
The reduction in the percentage of days with worsening asthma with montelukast use versus placebo use was not significant (24.3% vs 27.2%, P = .07). Prespecified subgroup analyses demonstrated nonsignificant trends favoring montelukast therapy in boys and older children but no effect by baseline ICS use or history of cold symptoms. Post hoc analysis showed a nonsignificant trend favoring montelukast therapy in reducing worsening asthma days for children commencing school after August 15 compared with earlier commencement.


CONCLUSIONS
Montelukast use was not significantly more effective than was placebo use in reducing the percentage of days with worsening asthma when initiated at the start of the school year. The effect of montelukast treatment on the fall peak in asthma burden may depend on sex, age, and the date of school return.
Weiss
Kevin B
KB
Institute for Healthcare Studies and Department of Medicine, Northwestern Feinberg School of Medicine, Chicago, Illinois, USA.
Gern
James E
JE
Johnston
Neil W
NW
Sears
Malcolm R
MR
Jones
Craig A
CA
Jia
Gang
G
Watkins
Molly W
MW
Smugar
Steven S
SS
Edelman
Jonathan M
JM
Grant
Evalyn N
EN
D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002985:Clinical Protocols; D003521:Cyclopropanes; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D010507:Periodicity; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D012574:Schools; D012621:Seasons; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D018926:Anti-Allergic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast