RCT of montelukast as prophylaxis for upper respiratory tract infections in children.
BACKGROUND
Infections with viruses causing upper respiratory tract infection (URI) are associated with increased leukotriene levels in the upper airways. Montelukast, a selective leukotriene-receptor antagonist, is an effective treatment of asthma and allergic rhinitis.


OBJECTIVE
To determine whether prophylactic treatment with montelukast reduces the incidence and severity of URI in children.


METHODS
A randomized, double-blind, placebo-controlled study was performed in 3 primary care pediatric ambulatory clinics in Israel. Healthy children aged 1 to 5 years were randomly assigned in a 1:1 ratio to receive 12-week treatment with 4 mg oral montelukast or look-alike placebo. Patients were excluded if they had a previous history of reactive airway disease. A study coordinator contacted the parents by phone once a week to obtain information regarding the occurrence of acute respiratory episodes. The parents received a diary card to record any acute symptoms of URI. The primary outcome measure was the number of URI episodes.


RESULTS
Three hundred children were recruited and randomly assigned into montelukast (n = 153) or placebo (n = 147) groups. One hundred thirty-one (85.6%) of the children treated with montelukast and 129 (87.7%) of the children treated with placebo completed 12 weeks of treatment. The number of weeks in which URI was reported was 30.4% in children treated with montelukast and 30.7% in children treated with placebo. There was no significant difference in any of the secondary variables between the groups.


CONCLUSIONS
In preschool-aged children, 12-week treatment with montelukast, compared with placebo, did not reduce the incidence of URI.
Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin 70300, Israel. erank@asaf.health.gov.il
Eran
E
Kozer
Zachi
Z
Lotem
Mahmud
M
Elgarushe
Rafael
R
Torgovicky
Raanan
R
Cohen
Herman A
HA
Cohen
Matitiahu
M
Berkovitch
D000085:Acetates / Q000627:therapeutic use*; D000284:Administration, Oral; D000554:Ambulatory Care Facilities; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007557:Israel; D008297:Male; D011804:Quinolines / Q000627:therapeutic use*; D012141:Respiratory Tract Infections / Q000453:epidemiology / Q000517:prevention & control*; D013440:Sulfides
D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast