title: Montelukast improves asthma control in asthmatic children maintained on inhaled corticosteroids.
abstract: 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.
authors.affiliation: Department of Pediatrics, Division of Allergy and Immunology, Children's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA. wanda.phipatanakul@tch.harvard.edu
authors.forename: Wanda
authors.initials: W
authors.lastname: Phipatanakul
authors.forename: Charles
authors.initials: C
authors.lastname: Greene
authors.forename: Sandra J
authors.initials: SJ
authors.lastname: Downes
authors.forename: Beth
authors.initials: B
authors.lastname: Cronin
authors.forename: T J
authors.initials: TJ
authors.lastname: Eller
authors.forename: Lynda C
authors.initials: LC
authors.lastname: Schneider
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Irani
mesh_terms: 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
chemical_list: D000085:Acetates; D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast