TY - JOUR
T1 - Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma
AU - Zeiger, Robert S.
AU - Szefler, Stanley J.
AU - Phillips, Brenda R.
AU - Schatz, Michael
AU - Martinez, Fernando D.
AU - Chinchilli, Vernon M.
AU - Lemanske, Robert F.
AU - Strunk, Robert C.
AU - Larsen, Gary
AU - Spahn, Joseph D.
AU - Bacharier, Leonard B.
AU - Bloomberg, Gordon R.
AU - Guilbert, Theresa W.
AU - Heldt, Gregory
AU - Morgan, Wayne J.
AU - Moss, Mark H.
AU - Sorkness, Christine A.
AU - Taussig, Lynn M.
N1 - Funding Information:
Disclosure of potential conflict of interest: R. Zeiger has consultant arrangements with AstraZeneca, Genentech, GlaxoSmithKline, and Novartis and has received grants from AstraZeneca, Aventis, GlaxoSmithKline, and Merck. S. Szefler has consultant arrangements with AstraZeneca, Aventis, GlaxoSmithKline, and Merck and has received grants from the National Heart, Lung, and Blood Institute (NHLBI) Childhood Asthma Research and Education (CARE) network and AstraZeneca. M Schatz has received grants from GlaxoSmithKline and Sanofi-Aventis and is on the speakers' bureau for AstraZeneca and Merck. F. Martinez is on the advisory board for Merck, Genentech, and Altana Pharma; has patent licensing arrangements with Wisconsin Alumni Research Foundation; and is on the speakers' bureau for AstraZeneca. V. Chinchilli has consultant arrangements with Pfizer, Eli Lilly, and Insmed and has received grants from the NHLBI CARE Network. R. Lemanske has consultant arrangements with AstraZeneca, Aventis, GlaxoSmithKline, and Novartis/Genentech; has received grants from the NHLBI and the National Institute of Allergy and Infectious Diseases (NIAID); and is on the speakers' bureau for Merck, GlaxoSmithKline, and AstraZeneca. G. Larsen is on the advisory board for GlaxoSmithKline and Schering-Plough. J. Spahn has consultant arrangements with GlaxoSmithKline, has received grants from Merck, and is on the speakers' bureau for GlaxoSmithKline. L. Bacharier has received grants from the NHLBI and is on the speakers' bureau for GlaxoSmithKline, Merck, Genentech, and AstraZeneca. T. Guilbert has consultant arrangements with GlaxoSmithKline; has received grants from GlaxoSmithKline and Genentech; is on the speakers' bureau for GlaxoSmithKline, AstraZeneca, Soma Medical Education, Innovia Education Institute, Antidote; and is part of the Exchange Program Steering Committee that designs CMEs. C. Sorkness has consultant arrangements with GlaxoSmithKline and AstraZeneca, has received grants from GlaxoSmithKline, and is on the speakers' bureau for GlaxoSmithKline, AstraZeneca, and Genentech. L. Taussig has consultant arrangements with GlaxoSmithKline.
PY - 2006/1
Y1 - 2006/1
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jaci.2005.10.012
DO - 10.1016/j.jaci.2005.10.012
M3 - Article
C2 - 16387583
AN - SCOPUS:29544438173
VL - 117
SP - 45
EP - 52
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
SN - 0091-6749
IS - 1
ER -