Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma.
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.
Zeiger
Robert S
RS
Department of Pediatrics, University of California-San Diego, San Diego, CA 92111, USA. robert.s.zeiger@kp.org
Szefler
Stanley J
SJ
Phillips
Brenda R
BR
Schatz
Michael
M
Martinez
Fernando D
FD
Chinchilli
Vernon M
VM
Lemanske
Robert F
RF
Strunk
Robert C
RC
Larsen
Gary
G
Spahn
Joseph D
JD
Bacharier
Leonard B
LB
Bloomberg
Gordon R
GR
Guilbert
Theresa W
TW
Heldt
Gregory
G
Morgan
Wayne J
WJ
Moss
Mark H
MH
Sorkness
Christine A
CA
Taussig
Lynn M
LM
D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000730:Androstadienes / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D018592:Cross-Over Studies; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D008297:Male; D009569:Nitric Oxide / Q000032:analysis; D011804:Quinolines / Q000627:therapeutic use*; D013440:Sulfides
D000085:Acetates; D000730:Androstadienes; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D009569:Nitric Oxide; D000068298:Fluticasone; C093875:montelukast