@article {585,
	title = {The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity},
	journal = {J Asthma},
	volume = {46},
	number = {4},
	year = {2009},
	pages = {413-20},
	type = {Journal Article},
	abstract = {To determine the effect of montelukast on asthma during the allergy season in children with persistent asthma and seasonal aeroallergen sensitivity.|This 3-week double-blind, placebo-controlled, parallel-group multicenter study compared daily montelukast 5 mg chewable tablets and placebo in patients 6-14 years of age with forced expiratory volume in 1 second (FEV(1)) > or = 60 and < or = 85\% predicted, persistent asthma that is also active during allergy season, and documented sensitivity to seasonal allergens. Concomitant inhaled corticosteroid use was permitted in up to 40\% of enrolled patients. The primary endpoint was the percentage change from baseline in FEV(1) over 3 weeks of treatment. Additional endpoints included the percentage change from baseline in beta-agonist use, average changes in daytime and nighttime symptom score, AM and PM peak expiratory flow rate (PEFR), investigator{\textquoteright}s global asthma evaluation, and parent/guardian global asthma evaluation at the end of the treatment period. Adverse experiences (AEs) were collected to assess safety and tolerability.|A total of 421 patients were randomized to montelukast (N = 203) or placebo (N = 218). For the primary endpoint, the percentage change from baseline FEV(1), montelukast was not significantly different from placebo (least squares mean 9.53\% vs. 9.15\%, respectively; p = 0.810). Compared with placebo, montelukast was associated with significantly lower (better) investigator{\textquoteright}s global asthma evaluation (LS mean 2.71 vs. 2.98; p < 0.05) and parent/guardian global asthma evaluation (LS mean: 2.63 vs. 2.90; p < 0.05) scores. There were no significant differences between treatment groups for the other efficacy evaluations. Both treatments were well tolerated, with no significant differences observed in AE rates.|Montelukast did not significantly improve FEV(1) compared with placebo over three weeks of treatment during the allergy season in pediatric patients with seasonal allergen sensitivity. (ClinicalTrials.gov identifier: NCT00289874).},
	keywords = {Acetates Administration, Allergic, Drug Double-Blind Method Drug Administration Schedule Female Forced Expiratory Volume Humans Hypersensitivity Male Multivariate Analysis Probability Prognosis Quinolines Reference Values Respiratory Function Tests Rhinitis, Oral Adolescent Asthma Child Cross-Over Studies Dose-Response Relationship, Seasonal Risk Assessment Severity of Illness Index Treatment Outcome},
	issn = {1532-4303},
	doi = {10.1080/02770900902847727},
	url = {http://www.ncbi.nlm.nih.gov/pubmed/19484680},
	author = {Papadopoulos, N. G. and Philip, G. and Giezek, H. and Watkins, M. and Smugar, S. S. and Polos, P. G.}
}
