Montelukast improves asthma control in asthmatic children maintained on inhaled corticosteroids.
BACKGROUND
Because of potential toxicities of inhaled corticosteroid (ICS) use in pediatric asthma, alternative or steroid-sparing therapy is desirable. There are no previous studies evaluating montelukast's steroid-sparing effects in children with asthma.


OBJECTIVE
To evaluate whether (1) montelukast as add-on therapy improves asthma symptom control and (2) montelukast provides steroid-sparing effects in children with asthma treated with low to moderate doses of ICS therapy.


METHODS
In a double-blind, placebo-controlled trial, 36 children ages 6 to 14 years with symptomatic asthma maintained on a stable low to moderate dose of ICSs were randomly assigned to receive montelukast or matching placebo for 24 weeks after a run-in period of 2 weeks (period I). During the trial, subjects kept daily asthma diary cards and monthly spirometry was performed. After a 4 week add-on period (period II), the subjects completed a 20-week (period III) ICS tapering period based on a predetermined protocol.


RESULTS
In period II, the difference in the number of rescue-free days was significantly higher in the montelukast group (P = 0.0001), and the number of rescue-free days per week was also significantly higher in montelukast-treated subjects compared with placebo subjects (P = 0.002). In period III, the percentage reduction in ICS dose was not significant between montelukast and placebo (P = 0.10), but the montelukast group experienced an average 17% decrease in ICS dose and the control group experienced an average 64% increase in ICS dose.


CONCLUSIONS
Montelukast treatment significantly increased the number of rescue-free days in symptomatic children with asthma.
Phipatanakul
Wanda
W
Department of Pediatrics, Division of Allergy and Immunology, Children's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA. wanda.phipatanakul@tch.harvard.edu
Greene
Charles
C
Downes
Sandra J
SJ
Cronin
Beth
B
Eller
T J
TJ
Schneider
Lynda C
LC
Irani
Anne-Marie
AM
D000085:Acetates / Q000627:therapeutic use*; D000281:Administration, Intranasal; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D003521:Cyclopropanes; D004311:Double-Blind Method; D004357:Drug Synergism; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D008297:Male; D010865:Pilot Projects; D011804:Quinolines / Q000627:therapeutic use*; D013440:Sulfides
D000085:Acetates; D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast