title: Efficacy of daily intranasal fluticasone propionate on ocular symptoms associated with seasonal allergic rhinitis.
abstract: BACKGROUND
  Allergic rhinitis (AR) is an inflammatory condition of the nasal mucosa characterized by symptoms of nasal discharge, itching, sneezing, and congestion. Ocular symptoms are commonly associated with AR and include itching or burning, tearing or watering, and redness. Intranasal corticosteroids are a mainstay of treatment, and their effect on nasal symptoms is well described.
  
  
  OBJECTIVE
  To demonstrate that a 14-day course of 200 μg/d of nasal fluticasone propionate is superior to placebo in relieving ocular symptoms associated with AR.
  
  
  METHODS
  This was a randomized, double-blind, parallel group, multicenter study comparing 200 μg/d of fluticasone propionate with placebo in patients with seasonal allergic rhinitis. The primary end point was mean change from baseline in patient-rated reflective total ocular symptom score (rTOSS). Key secondary end points included mean change from baseline in the morning and evening rTOSS, end-of-treatment assessment of response, and effect on activities of daily living. The primary analysis was performed using analysis of covariance with a linear fixed-effects model.
  
  
  RESULTS
  Fluticasone was statistically significantly more efficacious in reducing the ocular symptoms of AR than placebo. The least squares mean difference in the change from baseline of rTOSS was -0.36 (P = .002). A statistically significant difference in mean change from baseline was observed in favor of fluticasone for morning and evening rTOSS. Significantly more patients taking fluticasone achieved an overall response compared with placebo. Fluticasone had a significantly greater effect on daily living activities and was well tolerated.
  
  
  CONCLUSIONS
  This study supports the efficacy of fluticasone in treating ocular symptoms associated with AR.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01817790.
authors.affiliation: Sylvana Research Associates, San Antonio, Texas. Electronic address: pratner@sylvanaresearch.com.
authors.forename: Paul
authors.initials: P
authors.lastname: Ratner
authors.affiliation: Isis Clinical Research, Austin, Texas.
authors.forename: Julius
authors.initials: J
authors.lastname: Van Bavel
authors.affiliation: Kerville Research Associates, Kerrville, Texas.
authors.forename: Dale
authors.initials: D
authors.lastname: Mohar
authors.affiliation: Biogenics Research Institute, San Antonio, Texas.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Jacobs
authors.affiliation: Central Texas Health Research, New Braunfels, Texas.
authors.forename: Frank
authors.initials: F
authors.lastname: Hampel
authors.affiliation: Sirius Clinical Research, Austin, Texas.
authors.forename: William
authors.initials: W
authors.lastname: Howland
authors.affiliation: GlaxoSmithKline Consumer Healthcare, Parsippany, New Jersey.
authors.forename: Ritu
authors.initials: R
authors.lastname: Karwal
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D000068298:Fluticasone