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.
RCT Entities:
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.
Authors: Stephen P Peters; Susan J Kunselman; Nikolina Icitovic; Wendy C Moore; Rodolfo Pascual; Bill T Ameredes; Homer A Boushey; William J Calhoun; Mario Castro; Reuben M Cherniack; Timothy Craig; Loren Denlinger; Linda L Engle; Emily A DiMango; John V Fahy; Elliot Israel; Nizar Jarjour; Shamsah D Kazani; Monica Kraft; Stephen C Lazarus; Robert F Lemanske; Njira Lugogo; Richard J Martin; Deborah A Meyers; Joe Ramsdell; Christine A Sorkness; E Rand Sutherland; Stanley J Szefler; Stephen I Wasserman; Michael J Walter; Michael E Wechsler; Vernon M Chinchilli; Eugene R Bleecker Journal: N Engl J Med Date: 2010-09-19 Impact factor: 91.245
Authors: Gary L Larsen; Wayne Morgan; Gregory P Heldt; David T Mauger; Susan J Boehmer; Vernon M Chinchilli; Robert F Lemanske; Fernando Martinez; Robert C Strunk; Stanley J Szefler; Robert S Zeiger; Lynn M Taussig; Leonard B Bacharier; Theresa W Guilbert; Shelley Radford; Christine A Sorkness Journal: J Allergy Clin Immunol Date: 2008-12-12 Impact factor: 10.793
Authors: Douglas C Cowan; D Robin Taylor; Laura E Peterson; Jan O Cowan; Rochelle Palmay; Avis Williamson; Jef Hammel; Serpil C Erzurum; Stanley L Hazen; Suzy A A Comhair Journal: J Allergy Clin Immunol Date: 2014-12-06 Impact factor: 10.793
Authors: Jason S Debley; Elizabeth S Cochrane; Gregory J Redding; Edward R Carter Journal: Ann Allergy Asthma Immunol Date: 2012-06-26 Impact factor: 6.347