@article{3131318,
    title = "The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity",
    author = "Papadopoulos, N.G. and Philip, G. and Giezek, H. and Watkins, M. and Smugar, S.S. and Polos, P.G.",
    journal = "Journal of Asthma",
    year = "2009",
    volume = "46",
    number = "4",
    pages = "413-420",
    issn = "0277-0903, 1532-4303",
    doi = "10.1080/02770900902847727",
    keywords = "allergen;  corticosteroid;  montelukast;  placebo;  acetic acid derivative;  montelukast;  quinoline derivative, adolescent;  allergy;  article;  asthma;  bedtime dosage;  child;  circadian rhythm;  clinical trial;  controlled study;  corticosteroid therapy;  double blind procedure;  drug efficacy;  drug safety;  drug tolerability;  drug withdrawal;  evaluation;  female;  femur fracture;  forced expiratory volume;  human;  major clinical study;  male;  multicenter study;  peak expiratory flow;  preschool child;  respiratory distress;  school child;  scoring system;  seasonal aeroallergen sensitivity;  symptomatology;  treatment response;  asthma;  comparative study;  controlled clinical trial;  crossover procedure;  dose response;  drug administration;  hay fever;  hospitalization;  hypersensitivity;  immunology;  lung function test;  multivariate analysis;  oral drug administration;  probability;  prognosis;  randomized controlled trial;  reference value;  risk assessment;  treatment outcome, Acetates;  Administration, Oral;  Adolescent;  Asthma;  Child;  Cross-Over Studies;  Dose-Response Relationship, 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, Allergic, Seasonal;  Risk Assessment;  Severity of Illness Index;  Treatment Outcome",
    abstract = "Objective. To determine the effect of montelukast on asthma during the allergy season in children with persistent asthma and seasonal aeroallergen sensitivity. Design. 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 (FEV1) 60 and 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 FEV1 over 3 weeks of treatment. Additional endpoints included the percentage change from baseline in -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. Results. A total of 421 patients were randomized to montelukast (N = 203) or placebo (N = 218). For the primary endpoint, the percentage change from baseline FEV1, 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 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. Conclusion. Montelukast did not significantly improve FEV1 compared with placebo over three weeks of treatment during the allergy season in pediatric patients with seasonal allergen sensitivity."
}