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

Robert S. Zeiger, Stanley J. Szefler, Brenda R. Phillips, Michael Schatz, Fernando D. Martinez, Vernon M. Chinchilli, Robert F. Lemanske, Robert C. Strunk, Gary Larsen, Joseph D. Spahn, Leonard B. Bacharier, Gordon R. Bloomberg, Theresa W. Guilbert, Gregory Heldt, Wayne J. Morgan, Mark H. Moss, Christine A. Sorkness, Lynn M. Taussig

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212 Scopus citations


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 μg 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 (FEV1/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.

Original languageEnglish
Pages (from-to)45-52
Number of pages8
JournalJournal of Allergy and Clinical Immunology
Issue number1
StatePublished - Jan 2006


  • Asthma Control Questionnaire
  • Asthma control days
  • Asthma control outcomes
  • Exhaled nitric oxide
  • Fluticasone propionate
  • Inhaled corticosteroids
  • Leukotriene receptor antagonists
  • Montelukast
  • Pulmonary response


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