Fluticasone propionate aqueous nasal spray compared with terfenadine tablets in the treatment of seasonal allergic rhinitis

• Published in: Journal of allergy and clinical immunology Vol. 97; no. 4; pp. 915 - 921
• Main Authors: Bronsky, Edwin A., Dockhorn, Robert J., Meltzer, Eli O., Shapiro, Gail, Boltansky, Howard, LaForce, Craig, Ransom, James, Weiler, John M., Blumenthal, Malcolm, Weakley, Suzanne, Wisniewski, Michael, Field, Elizabeth, Rogenes, Paula
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.04.1996; Elsevier
• Subjects: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Aged; Androstadienes - administration & dosage; Androstadienes - adverse effects; Androstadienes - therapeutic use; Anti-Allergic Agents - administration & dosage; Anti-Allergic Agents - adverse effects; Anti-Allergic Agents - therapeutic use; antihistamine; Biological and medical sciences; Child; comparative study; Double-Blind Method; Female; Fluticasone; Fluticasone propionate; glucocorticosteroid; Histamine and antagonists. Allergy; Humans; Male; Medical sciences; Middle Aged; Nebulizers and Vaporizers; Pharmacology. Drug treatments; Rhinitis, Allergic, Seasonal - complications; Rhinitis, Allergic, Seasonal - drug therapy; seasonal allergic rhinitis; Tablets; terfenadine; Terfenadine - administration & dosage; Terfenadine - therapeutic use; seasonal allergic rhinitis; comparative study; terfenadine; antihistamine; glucocorticosteroid; Fluticasone propionate; Human; Corticosteroid; Immunopathology; Allergy; Nose disease; Rhinitis; Multicenter study; Oral administration; Antihistaminic; H1 receptor; Chemotherapy; Treatment; Double blind study; ENT disease; Antagonist; Season; Intranasally administration; Comparative study
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/S0091-6749(96)80065-0

Background: Comparative studies with topical corticosteroids and antithistamines for treatment of allergic rhinitis have not always demonstrated clear distinctions between the two on the basis of therapeutic efficacy. Objective: This study was designed to compare the efficacy and tolerability of fluticasone propionate aqueous nasal spray with those of terfenadine in the treatment of seasonal allergic rhinitis. Methods: Three hundred forty-eight patients with allergic rhinitis were given fluicasone propionate aqueous nasal spray (200 μg once daily), terfenadine tablets (60 mg twice daily), or placebo for 4 weeks in a multicenter, randomized, double-blind, double-dummy, parallel-group study. Results: Clinician-rated total nasal symptom scores after 1, 2, 3, and 4 weeks of therapy and patient-rated total nasal symptom scores throughout treatment were significantly ( p<0.05) lower in the fluiticasone propionate group compared with the terfenadine group or the placebo group. Terfenadine was not statistically different from placebo on the basis of clinician-rated nasal symptom scores, except for sneezing. Total nasal airflow, measured by rhinomanometry, significantly ( p<0.05) improved in the fluticasone propionate group compared with the terfenadine group or the placebo group. More fluticasone propionate-treated patients compared with placebo-treated patients had reduced nasal mucosal eosinophil counts after 4 weeks of therapy ( p<0.05). No serious or unusual drug-related adverse events were reported. Morning plasma cortisol concentrations after 4 weeks of therapy did not differ among groups. Conclusion: Fluticasone propionate aqueous nasal spray is more effective than terfenadine tablets for treatment of seasonal allergic rhinitis.