title: Fexofenadine improves the quality of life and work productivity in Japanese patients with seasonal allergic rhinitis during the peak cedar pollinosis season.
abstract: BACKGROUND
  Although currently in its infancy, quality of life (QOL) research in Japan is rapidly expanding and is expected to become a standard outcome measure in clinical trials. In Japan, QOL has not previously been assessed in patients with allergic rhinitis (AR); we report the first clinical study applying the recently validated Japanese translations of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Questionnaire to assess the effects of the oral antihistamine, fexofenadine, on QOL and work productivity due to cedar pollinosis.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled, single-site study was conducted during the peak cedar pollinosis season in Japan. After a 7-day run-in period, subjects were randomized to receive fexofenadine HCl 60 mg twice daily (bid) or placebo for 2 weeks.
  
  
  RESULTS
  Overall, 206 Japanese subjects with AR were included in the intention-to- treat population (fexofenadine, n = 104, and placebo, n = 102). Fexofenadine statistically significantly improved overall QOL compared with placebo (p = 0.005) and improvements were reported in the RQLQ domains: activities (p = 0.047), practical problems (p = 0.003), nasal symptoms (p = 0.003) and eye symptoms (p </= 0.001). Clinically significant improvements in practical problems, eye symptoms and activity limitations, exceeding the 0.05 level, were observed with fexofenadine. These improvements in QOL were associated with significant symptom relief (p < 0.001 vs. placebo). Improvements in impairment at work were also reported with fexofenadine.
  
  
  CONCLUSIONS
  In Japan, this is the first clinical study to show that fexofenadine HCl (60 mg b.i.d.) improves overall QOL and work productivity in patients with seasonal AR using validated Japanese instruments.
authors.affiliation: Nippon Medical School, Tokyo, Japan. ent-kimi@nms.ac.jp
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Okubo
authors.forename: Minoru
authors.initials: M
authors.lastname: Gotoh
authors.forename: Kenichi
authors.initials: K
authors.lastname: Shimada
authors.forename: Masayo
authors.initials: M
authors.lastname: Ritsu
authors.forename: Minoru
authors.initials: M
authors.lastname: Okuda
authors.forename: Bruce
authors.initials: B
authors.lastname: Crawford
mesh_terms: D000328:Adult; D000485:Allergens; D032485:Cryptomeria / Q000276:immunology; D004311:Double-Blind Method; D004526:Efficiency; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008297:Male; D011058:Pollen; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000276:immunology; D016593:Terfenadine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000485:Allergens; D006634:Histamine H1 Antagonists; D016593:Terfenadine; C093230:fexofenadine