title: Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast.
abstract: BACKGROUND
  The safety and efficacy of intranasal corticosteroids for the treatment of allergic rhinitis is well documented in the literature. Additionally, an expert panel has concluded that intranasal corticosteroids are the first line of therapy when obstruction is a major component of rhinitis. Montelukast is a leukotriene receptor antagonist recently approved for the treatment of seasonal allergic rhinitis (SAR).
  
  
  OBJECTIVE
  This randomized, double-blind, double-dummy, parallel-group study was conducted to compare the effectiveness of a 15-day course of intranasal fluticasone propionate 200 microg, once daily (FP200QD), to oral montelukast 10 mg, once daily (MON10QD), in relieving daytime and nighttime nasal symptoms associated with SAR.
  
  
  METHODS
  The intent-to-treat (ITT) analysis population consisted of 705 eligible males and females (> or = 15 years) with SAR randomized to either FP200QD (N = 353) or MON10QD (N = 352). The primary efficacy endpoint was the mean change from baseline in subject-rated daytime total nasal symptom scores (the sum of four individual scores: nasal congestion, itching, rhinorrhea, and sneezing), evaluated via visual analog scales, and averaged over weeks 1 to 2. Secondary endpoints included the four daytime individual nasal symptom scores, the nighttime total, and individual nasal symptom scores (each evaluated on a four-point scale from 0 to 3).
  
  
  RESULTS
  Statistically significant differences favoring FP200QD over MON10QD were observed for the mean change from baseline in daytime total nasal symptom scores (P < 0.001), daytime individual nasal symptom scores (P < 0.001), nighttime total (P < 0.001), and all individual nasal symptom scores (P < or = 0.002) over the 15-day treatment period. FP200QD and MON10QD were both well tolerated.
  
  
  CONCLUSIONS
  The results of this well controlled study demonstrated that FP200QD was consistently superior to MON10QD with regard to every efficacy endpoint evaluated, including daytime and nighttime nasal congestion, in subjects with SAR.
authors.affiliation: Sylvana Research Associates, San Antonio, Texas, USA.
authors.forename: Paul H
authors.initials: PH
authors.lastname: Ratner
authors.forename: William C
authors.initials: WC
authors.lastname: Howland
authors.forename: Raiqua
authors.initials: R
authors.lastname: Arastu
authors.forename: Edward E
authors.initials: EE
authors.lastname: Philpot
authors.forename: Kristofer C
authors.initials: KC
authors.lastname: Klein
authors.forename: Charlotte A
authors.initials: CA
authors.lastname: Baidoo
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Faris
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Rickard
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000281:Administration, Intranasal; D000284:Administration, Oral; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage*; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D003521:Cyclopropanes; D005260:Female; D000068298:Fluticasone; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage*; D017336:Loratadine / Q000008:administration & dosage; D008297:Male; D015508:Nasal Obstruction / Q000188:drug therapy; D011537:Pruritus / Q000188:drug therapy; D011804:Quinolines / Q000008:administration & dosage*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012912:Sneezing / Q000187:drug effects; D013440:Sulfides
chemical_list: D000085:Acetates; D000730:Androstadienes; D018926:Anti-Allergic Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D017336:Loratadine; D000068298:Fluticasone; C093875:montelukast