title: Efficacy of montelukast during the allergy season in patients with chronic asthma and seasonal aeroallergen sensitivity.
abstract: BACKGROUND
  Montelukast has proven efficacy in the treatment of chronic asthma and seasonal allergic rhinitis, but it has not been evaluated in the subpopulation of asthmatic patients with seasonal asthma symptoms.
  
  
  OBJECTIVE
  To determine the effectiveness of montelukast treatment in improving the control of asthma symptoms during the allergy season in patients with active asthma and seasonal aeroallergen sensitivity.
  
  
  METHODS
  Adults with a history of chronic asthma who are also symptomatic during the allergy season and with skin test sensitivity to seasonal aeroallergens were enrolled in a randomized, parallel-group, multicenter study with a 1-week, single-blind, placebo run-in period followed by 3 weeks of double-blind treatment during the spring of 2004. After the run-in period, eligible patients were randomly assigned to receive either oral montelukast (10 mg) or placebo. Daytime and nighttime asthma symptom scores, beta-agonist use, and morning and evening peak expiratory flow rates were recorded daily using an electronic diary. The primary end point was mean change from baseline to week 3 in the daytime asthma symptom score.
  
  
  RESULTS
  Of 455 randomized patients, 433 completed the study. Compared with placebo, treatment with montelukast resulted in a significant improvement from baseline in the daytime asthma symptom score (-0.54 vs -0.34; P = .002) and in beta-agonist use, nighttime symptoms, and peak expiratory flow rates. Few patients in the montelukast and placebo groups discontinued study participation because of asthma (1.3% and 3.0%, respectively).
  
  
  CONCLUSIONS
  In patients with chronic asthma and seasonal aeroallergen sensitivity, montelukast treatment provided significant asthma control during the allergy season compared with placebo.
authors.affiliation: Department of Medicine, University of Wisconsin Medical School, Madison, Wisconsin 53792, USA. wwb@medicine.wisc.edu
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Casale
authors.forename: Mark S
authors.initials: MS
authors.lastname: Dykewicz
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: Steven R
authors.initials: SR
authors.lastname: Bird
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Hustad
authors.forename: Evalyn
authors.initials: E
authors.lastname: Grant
authors.forename: Robert K
authors.initials: RK
authors.lastname: Zeldin
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Edelman
mesh_terms: D000085:Acetates / Q000627:therapeutic use*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use; D001249:Asthma / Q000150:complications* / Q000188:drug therapy*; D002908:Chronic Disease; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D011804:Quinolines / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications* / Q000188:drug therapy*; D013440:Sulfides
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast