title: Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis.
abstract: BACKGROUND
  Perennial allergic rhinitis (PAR) is a persistent allergic inflammation of the upper respiratory tract due to year-round allergen exposure.
  
  
  OBJECTIVE
  To evaluate the leukotriene receptor antagonist montelukast for the treatment of PAR.
  
  
  METHODS
  Protocol 265 was a 2-arm study performed during the winter. After a placebo run-in period, adults with perennial allergen sensitivity and active symptoms of PAR were randomized to receive 10 mg of montelukast (n=1002) or placebo (n=990) once daily during a 6-week, double-blind, active-treatment period. The primary end point was the daytime nasal symptoms score, defined as the average of scores for nasal congestion, rhinorrhea, and sneezing rated daily by patients.
  
  
  RESULTS
  Statistically significant improvements in PAR symptoms were seen in patients treated with montelukast. Their daytime nasal symptoms scores were reduced during treatment compared with those of the placebo group: the difference between treatments in least squares mean change from baseline was -0.08 (95% confidence interval [CI], -0.12 to -0.04; P < .001). Montelukast treatment also improved global evaluations of allergic rhinitis by patients and Rhinoconjunctivitis Quality of Life Questionnaire scores: differences vs the placebo group were -0.15 (95% CI, -0.27 to -0.04; P < .01) and -0.15 (95% CI, -0.24 to -0.06; P < .001), respectively. Other end points that showed statistically significant improvement with montelukast treatment were nighttime symptoms and each of the 4 nasal symptoms (congestion, rhinorrhea, sneezing, and itching). The treatment effects of montelukast were stable and persistent during the entire 6 weeks of treatment.
  
  
  CONCLUSIONS
  Montelukast provided statistically significant relief of PAR symptoms during 6 weeks of treatment.
authors.affiliation: Allied Research International, Mississauga, Ontario, Canada. PPatel@allied-research.com
authors.forename: Piyush
authors.initials: P
authors.lastname: Patel
authors.forename: George
authors.initials: G
authors.lastname: Philip
authors.forename: William
authors.initials: W
authors.lastname: Yang
authors.forename: Robert
authors.initials: R
authors.lastname: Call
authors.forename: Friedrich
authors.initials: F
authors.lastname: Horak
authors.forename: Craig
authors.initials: C
authors.lastname: LaForce
authors.forename: Leen
authors.initials: L
authors.lastname: Gilles
authors.forename: Graigory C
authors.initials: GC
authors.lastname: Garrett
authors.forename: S Balachandra
authors.initials: SB
authors.lastname: Dass
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Knorr
authors.forename: Theodore F
authors.initials: TF
authors.lastname: Reiss
mesh_terms: D000085:Acetates / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D012221:Rhinitis, Allergic, Perennial; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast