Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma

J Allergy Clin Immunol. 2006 Jan;117(1):45-52. doi: 10.1016/j.jaci.2005.10.012.


Background: Outcome data are needed to base recommendations for controller asthma medication use in school-aged children.

Objective: We sought to determine intraindividual and interindividual response profiles and predictors of response to an inhaled corticosteroid (ICS) and a leukotriene receptor antagonist (LTRA).

Methods: An ICS, fluticasone propionate (100 mug twice daily), and an LTRA, montelukast (5-10 mg nightly, age dependent), were administered to children ages 6 to 17 years with mild-to-moderate persistent asthma using only as-needed bronchodilators in a multicenter, double-masked, 2-sequence, 16-week crossover trial. Clinical, pulmonary, and inflammatory responses to these controllers were evaluated.

Results: Improvements in most clinical asthma control measures occurred with both controllers. However, clinical outcomes (asthma control days [ACDs], the validated Asthma Control Questionnaire, and albuterol use), pulmonary responses (FEV(1)/forced vital capacity, peak expiratory flow variability, morning peak expiratory flow, and measures of impedance), and inflammatory biomarkers (exhaled nitric oxide [eNO]) improved significantly more with fluticasone than with montelukast treatment. eNO was both a predictor of ACDs (P = .011) and a response indicator (P = .003) in discriminating the difference in ACD response between fluticasone and montelukast.

Conclusions: The more favorable clinical, pulmonary, and inflammatory responses to an ICS than to an LTRA provide pediatric-based group evidence to support ICSs as the preferred first-line therapy for mild-to-moderate persistent asthma in children. eNO, as a predictor of response, might help to identify individual children not receiving controller medication who achieve a greater improvement in ACDs with an ICS compared with an LTRA.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / therapeutic use*
  • Adolescent
  • Androstadienes / therapeutic use*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Child
  • Cross-Over Studies
  • Cyclopropanes
  • Double-Blind Method
  • Female
  • Fluticasone
  • Forced Expiratory Volume / drug effects
  • Humans
  • Leukotriene Antagonists / therapeutic use*
  • Male
  • Nitric Oxide / analysis
  • Quinolines / therapeutic use*
  • Sulfides


  • Acetates
  • Androstadienes
  • Cyclopropanes
  • Leukotriene Antagonists
  • Quinolines
  • Sulfides
  • Nitric Oxide
  • Fluticasone
  • montelukast