INTRANASAL FLUTICASONE PROPIONATE IS MORE EFFECTIVE THAN TERFENADINE TABLETS FOR SEASONAL ALLERGIC RHINITIS

Background: We compared the efficacy and tolerability of the intranasa l corticosteroid fluticasone propionate with that of the antihistamine terfenadine in patients with seasonal allergic rhinitis. Methods: Two hundred thirty-two adults and adolescents with seasonal allergic rhin itis received intranasal fluticasone propionate (200 mu g once daily), terfenadine tablets (60 mg twice daily), or placebo for 2 weeks in a double-blind, randomized, parallel-group study. Main outcome measures were clinician- and patient-rated individual and total nasal symptom s cores (based on ratings of nasal obstruction, sneezing, nasal itching, and rhinorrhea); clinician-rated overall response to therapy; changes in nasal inflammatory cell counts; adverse events; and morning plasma cortisol concentrations. Results: Both clinician- and patient-rated t otal and individual nasal symptom scores were significantly lower in t he fluticasone group than in either the terfenadine group or the place bo group at nearly every measured time point throughout the treatment period. After 2 weeks of therapy, clinician-rated total nasal symptom scores decreased by 49% in the fluticasone group compared with 27% in the terfenadine group and 19% in the placebo group. In general, therap y with terfenadine was not statistically distinguishable from that wit h placebo based on patient-rated total or individual nasal symptom sco res. According to clinician ratings, 64% of fluticasone-treated patien ts compared with 49% and 44% of patients treated with terfenadine and placebo, respectively, experienced significant or moderate improvement . A greater percentage of fluticasone-treated patients compared with e ither terfenadine- or placebo-treated patients experienced reductions in intranasal eosinophil and basophil counts after 2 weeks of therapy. No unusual or serious drug-related adverse events were reported. Morn ing plasma cortisol concentrations after 2 weeks of therapy did not di ffer among groups. Conclusion: Fluticasone aqueous nasal spray, a well -tolerated corticosteroid preparation that can be administered once da ily, is more effective than terfenadine tablets or placebo in controll ing symptoms of seasonal allergic rhinitis.