title: Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies.
abstract: BACKGROUND
  Montelukast, a potent leukotriene receptor antagonist, is an effective therapy for symptoms of seasonal allergic rhinitis, a disease governed by patients' individual sensitivity and exposure to relevant allergens.
  
  
  OBJECTIVE
  To evaluate the relationship of montelukast treatment effect vs pollen exposure in studies conducted during 3 consecutive fall allergy seasons.
  
  
  METHODS
  A combined analysis of these multicenter, randomized, double-blind, parallel-group studies was performed; 1 of the 3 studies is presented for the first time in this article. After a placebo run-in period, 1,862 symptomatic patients were randomly assigned to receive either a 10-mg montelukast tablet (n = 929) or placebo (n = 933) once daily for 2 weeks. Pollen exposure was summarized by mean daily weed pollen count. The interaction between treatment effect and pollen exposure was evaluated on the primary efficacy endpoint and daytime nasal symptom score, as rated by patients; also evaluated was the influence of the timing of the 2-week treatment period relative to the peak of the weed pollen season.
  
  
  RESULTS
  Montelukast significantly improved daytime nasal symptoms score and individual scores of congestion, rhinorrhea, itching, and sneezing compared with placebo. There was a significant interaction (P < .043) between treatment effect and weed pollen exposure; a larger treatment effect was noted in patients exposed to higher pollen counts. An interaction between treatment effect and timing of treatment in relation to peak pollen season was suggested.
  
  
  CONCLUSIONS
  Montelukast significantly improved daytime nasal symptoms score in patients with seasonal allergic rhinitis, and the effect was greater in patients exposed to higher pollen levels.
authors.affiliation: New England Research Center, North Dartmouth, Massachusetts, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Chervinsky
authors.forename: George
authors.initials: G
authors.lastname: Philip
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Malice
authors.forename: Jose
authors.initials: J
authors.lastname: Bardelas
authors.forename: Anjuli
authors.initials: A
authors.lastname: Nayak
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Marchal
authors.forename: Janet
authors.initials: J
authors.lastname: van Adelsberg
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
authors.forename: Carol A
authors.initials: CA
authors.lastname: Tozzi
authors.forename: Theodore F
authors.initials: TF
authors.lastname: Reiss
mesh_terms: D000085:Acetates / Q000627:therapeutic use*; D000328:Adult; D003521:Cyclopropanes; D005260:Female; D006801:Humans; D020024:Leukotriene Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011058:Pollen / Q000276:immunology*; D011804:Quinolines / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012621:Seasons; D013440:Sulfides
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast