<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Papadopoulos, N. G.</style></author><author><style face="normal" font="default" size="100%">Philip, G.</style></author><author><style face="normal" font="default" size="100%">Giezek, H.</style></author><author><style face="normal" font="default" size="100%">Watkins, M.</style></author><author><style face="normal" font="default" size="100%">Smugar, S. S.</style></author><author><style face="normal" font="default" size="100%">Polos, P. G.</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity</style></title><secondary-title><style face="normal" font="default" size="100%">J Asthma</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Acetates Administration</style></keyword><keyword><style  face="normal" font="default" size="100%">Allergic</style></keyword><keyword><style  face="normal" font="default" size="100%">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</style></keyword><keyword><style  face="normal" font="default" size="100%">Oral Adolescent Asthma Child Cross-Over Studies Dose-Response Relationship</style></keyword><keyword><style  face="normal" font="default" size="100%">Seasonal Risk Assessment Severity of Illness Index Treatment Outcome</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2009</style></year></dates><urls><web-urls><url><style face="normal" font="default" size="100%">http://www.ncbi.nlm.nih.gov/pubmed/19484680</style></url></web-urls></urls><number><style face="normal" font="default" size="100%">4</style></number><volume><style face="normal" font="default" size="100%">46</style></volume><pages><style face="normal" font="default" size="100%">413-20</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">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)) &gt; or = 60 and &lt; 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'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's global asthma evaluation (LS mean 2.71 vs. 2.98; p &lt; 0.05) and parent/guardian global asthma evaluation (LS mean: 2.63 vs. 2.90; p &lt; 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).</style></abstract><work-type><style face="normal" font="default" size="100%">Journal Article</style></work-type></record></records></xml>