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Intranasal Fluticasone Propionate Is More Effective Than Terfenadine Tablets for Seasonal Allergic Rhinitis

Intranasal Fluticasone Propionate Is More Effective Than Terfenadine Tablets for Seasonal... Abstract Background: We compared the efficacy and tolerability of the intranasal 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 rhinitis received intranasal fluticasone propionate (200 μnce 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 scores (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 total and individual nasal symptom scores were significantly lower in the fluticasone group than in either the terfenadine group or the placebo 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, therapy with terfenadine was not statistically distinguishable from that with placebo based on patient-rated total or individual nasal symptom scores. According to clinician ratings, 64% of fluticasone-treated patients compared with 49% and 44% of patients treated with terfenadine and placebo, respectively, experienced significant or moderate improvement. A greater percentage of fluticasonetreated patients compared with either 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. Morning plasma cortisol concentrations after 2 weeks of therapy did not differ among groups. Conclusion: Fluticasone aqueous nasal spray, a well-tolerated corticosteroid preparation that can be administered once daily, is more effective than terfenadine tablets or placebo in controlling symptoms of seasonal allergic rhinitis.(Arch Intern Med. 1994;154:2699-2704) References 1. McNamara RM. Approach to rhinitis . Emerg Med Clin North Am. 1987;5:279-292. 2. Delafuente JC, Davis TA, Davis JA. Pharmacotherapy of allergic rhinitis . Clin Pharm. 1989;8:474-485. 3. Ziering RW. Immediate and late side effects of hay fever . Postgrad Med. 1989; 85:183-190. 4. Ziering RW, Klein GL. Allergic rhinitis: measures to control the misery . Post-grad Med. 1992;91:225-232. 5. Naclerio RM, Togias AG. The nasal allergic reaction: observations of the role of histamine . Clin Exp Allergy . 1991;21:13-19.Crossref 6. Virant FS. Allergic rhinitis . Pediatr Rev. 1992;13:323-328.Crossref 7. Kaliner MA. Introduction . Respir Med. 1990;84( (suppl A) ):1.Crossref 8. Bousquet J, Chanez P, Michel FB. Pathophysiology and treatment of seasonal allergic rhinitis . Respir Med. 1990;84( (suppl A) ):11-16.Crossref 9. Mabry RL. Topical pharmacotherapy for allergic rhinitis: new agents . South Med J. 1992;85:149-154.Crossref 10. Meltzer EO. Treating allergic rhinitis: overview and update . Am J Asthma Allergy Pediatr. 1992;6:13-17. 11. Meltzer EO, Schatz M. Pharmacotherapy of rhinitis: 1987 and beyond . Immunol Allergy Clin North Am. 1987;7:57-91. 12. Sorkin EM, Heel RC. Terfenadine: a review of its pharmacodynamic properties and therapeutic efficacy . Drugs . 1985;29:34-46.Crossref 13. Simons FER. H1-receptor antagonists: clinical pharmacology and therapeutics . J Allergy Clin Immunol. 1989;84:845-861.Crossref 14. Phillipps GH. Structure-activity relationships of topically active steroids: the selection of fluticasone propionate . Respir Med. 1990;84( (suppl A) ):19-23.Crossref 15. Harding SM. The human pharmacology of fluticasone propionate . Respir Med. 1990;84( (suppl A) ):25-29.Crossref 16. Ratner PH, Paull BR, Findlay SR, et al. Fluticasone propionate given once daily is as effective for seasonal allergic rhinitis as beclomethasone dipropionate given twice daily . J Allergy Clin Immunol. 1992;90:285-291.Crossref 17. LaForce C, Dockhorn R, Findlay S, et al. Fluticasone propionate treatment for seasonal allergic rhinitis is safe and effective in adults and adolescents . J Allergy Clin Immunol. 1991;87:153.Crossref 18. Findlay SR, Johnston MC. The Juniperus ashei . J Allergy Clin Immunol. 1986; 77:116.Crossref 19. Ramirez DA. The natural history of mountain cedar pollinosis . J Allergy Clin Immunol. 1984;73:88-93.Crossref 20. Linder A. Symptom scores as measures of the severity of rhinitis . Clin Allergy . 1988;18:29-37.Crossref 21. Landis RJ, Heyman ER, Koch GG. Average partial association in three-way contingency tables: a review and discussion of alternative tests . Int Stat Rev. 1978; 46:237-254.Crossref 22. van Elteren PH. On the combination of independent two-sample tests of Wilcoxon . Bull Int Stat Inst. 1960;37:351-361. 23. Nathan RA, Bronsky EA, Fireman P, et al. Once daily fluticasone propionate aqueous nasal spray is an effective treatment for seasonal allergic rhinitis . Ann Allergy. 1991;67:332-338. 24. Howarth PH. Allergic rhinitis: a rational choice of treatment . Respir Med. 1989; 83:179-188.Crossref 25. Howarth PH, Holgate ST. Comparative trial of two nonsedative H1 antihistamines, terfenadine and astemizole, for hay fever . Thorax. 1984;39:668-672.Crossref 26. Lancer JM, Jones AS, Stevens JC, Beckingham E. A comparison by rhinomanometry of beclomethasone and terfenadine in the treatment of seasonal rhinitis . J Laryngol Otol. 1987;101:350-354.Crossref 27. van As A, Bronsky E, Grossman J, Meltzer E, Ratner P, Reed C. Dose tolerance study of fluticasone propionate aqueous nasal spray in patients with seasonal allergic rhinitis . Ann Allergy . 1991;67:156-162. 28. Rogenes P, van As A, Kral K. Fluticasone propionate 200 mcg once a day relieves symptoms of allergic rhinitis within 24 to 48 hours . Allergy Clin Immunol News . 1991( (suppl 1) ):337. 29. Meltzer EO, Orgel HA, Bronsky EA, et al. A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology . J Allergy Clin Immunol. 1990;86: 221-230.Crossref 30. Meltzer EO, Jalowayski AA, Field EA, Rogenes PR, Kral KM. Intranasal fluticasone propionate reduces histamine and tryptase in the mucosa of allergic rhinitis patients . J Allergy Clin Immunol. 1993;91:298. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Intranasal Fluticasone Propionate Is More Effective Than Terfenadine Tablets for Seasonal Allergic Rhinitis

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Publisher
American Medical Association
Copyright
Copyright © 1994 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/archinte.1994.00420230086010
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Abstract

Abstract Background: We compared the efficacy and tolerability of the intranasal 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 rhinitis received intranasal fluticasone propionate (200 μnce 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 scores (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 total and individual nasal symptom scores were significantly lower in the fluticasone group than in either the terfenadine group or the placebo 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, therapy with terfenadine was not statistically distinguishable from that with placebo based on patient-rated total or individual nasal symptom scores. According to clinician ratings, 64% of fluticasone-treated patients compared with 49% and 44% of patients treated with terfenadine and placebo, respectively, experienced significant or moderate improvement. A greater percentage of fluticasonetreated patients compared with either 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. Morning plasma cortisol concentrations after 2 weeks of therapy did not differ among groups. Conclusion: Fluticasone aqueous nasal spray, a well-tolerated corticosteroid preparation that can be administered once daily, is more effective than terfenadine tablets or placebo in controlling symptoms of seasonal allergic rhinitis.(Arch Intern Med. 1994;154:2699-2704) References 1. McNamara RM. Approach to rhinitis . Emerg Med Clin North Am. 1987;5:279-292. 2. Delafuente JC, Davis TA, Davis JA. Pharmacotherapy of allergic rhinitis . Clin Pharm. 1989;8:474-485. 3. Ziering RW. Immediate and late side effects of hay fever . Postgrad Med. 1989; 85:183-190. 4. Ziering RW, Klein GL. Allergic rhinitis: measures to control the misery . Post-grad Med. 1992;91:225-232. 5. Naclerio RM, Togias AG. The nasal allergic reaction: observations of the role of histamine . Clin Exp Allergy . 1991;21:13-19.Crossref 6. Virant FS. Allergic rhinitis . Pediatr Rev. 1992;13:323-328.Crossref 7. Kaliner MA. Introduction . Respir Med. 1990;84( (suppl A) ):1.Crossref 8. Bousquet J, Chanez P, Michel FB. Pathophysiology and treatment of seasonal allergic rhinitis . Respir Med. 1990;84( (suppl A) ):11-16.Crossref 9. Mabry RL. Topical pharmacotherapy for allergic rhinitis: new agents . South Med J. 1992;85:149-154.Crossref 10. Meltzer EO. Treating allergic rhinitis: overview and update . Am J Asthma Allergy Pediatr. 1992;6:13-17. 11. Meltzer EO, Schatz M. Pharmacotherapy of rhinitis: 1987 and beyond . Immunol Allergy Clin North Am. 1987;7:57-91. 12. Sorkin EM, Heel RC. Terfenadine: a review of its pharmacodynamic properties and therapeutic efficacy . Drugs . 1985;29:34-46.Crossref 13. Simons FER. H1-receptor antagonists: clinical pharmacology and therapeutics . J Allergy Clin Immunol. 1989;84:845-861.Crossref 14. Phillipps GH. Structure-activity relationships of topically active steroids: the selection of fluticasone propionate . Respir Med. 1990;84( (suppl A) ):19-23.Crossref 15. Harding SM. The human pharmacology of fluticasone propionate . Respir Med. 1990;84( (suppl A) ):25-29.Crossref 16. Ratner PH, Paull BR, Findlay SR, et al. Fluticasone propionate given once daily is as effective for seasonal allergic rhinitis as beclomethasone dipropionate given twice daily . J Allergy Clin Immunol. 1992;90:285-291.Crossref 17. LaForce C, Dockhorn R, Findlay S, et al. Fluticasone propionate treatment for seasonal allergic rhinitis is safe and effective in adults and adolescents . J Allergy Clin Immunol. 1991;87:153.Crossref 18. Findlay SR, Johnston MC. The Juniperus ashei . J Allergy Clin Immunol. 1986; 77:116.Crossref 19. Ramirez DA. The natural history of mountain cedar pollinosis . J Allergy Clin Immunol. 1984;73:88-93.Crossref 20. Linder A. Symptom scores as measures of the severity of rhinitis . Clin Allergy . 1988;18:29-37.Crossref 21. Landis RJ, Heyman ER, Koch GG. Average partial association in three-way contingency tables: a review and discussion of alternative tests . Int Stat Rev. 1978; 46:237-254.Crossref 22. van Elteren PH. On the combination of independent two-sample tests of Wilcoxon . Bull Int Stat Inst. 1960;37:351-361. 23. Nathan RA, Bronsky EA, Fireman P, et al. Once daily fluticasone propionate aqueous nasal spray is an effective treatment for seasonal allergic rhinitis . Ann Allergy. 1991;67:332-338. 24. Howarth PH. Allergic rhinitis: a rational choice of treatment . Respir Med. 1989; 83:179-188.Crossref 25. Howarth PH, Holgate ST. Comparative trial of two nonsedative H1 antihistamines, terfenadine and astemizole, for hay fever . Thorax. 1984;39:668-672.Crossref 26. Lancer JM, Jones AS, Stevens JC, Beckingham E. A comparison by rhinomanometry of beclomethasone and terfenadine in the treatment of seasonal rhinitis . J Laryngol Otol. 1987;101:350-354.Crossref 27. van As A, Bronsky E, Grossman J, Meltzer E, Ratner P, Reed C. Dose tolerance study of fluticasone propionate aqueous nasal spray in patients with seasonal allergic rhinitis . Ann Allergy . 1991;67:156-162. 28. Rogenes P, van As A, Kral K. Fluticasone propionate 200 mcg once a day relieves symptoms of allergic rhinitis within 24 to 48 hours . Allergy Clin Immunol News . 1991( (suppl 1) ):337. 29. Meltzer EO, Orgel HA, Bronsky EA, et al. A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology . J Allergy Clin Immunol. 1990;86: 221-230.Crossref 30. Meltzer EO, Jalowayski AA, Field EA, Rogenes PR, Kral KM. Intranasal fluticasone propionate reduces histamine and tryptase in the mucosa of allergic rhinitis patients . J Allergy Clin Immunol. 1993;91:298.

Journal

Archives of Internal MedicineAmerican Medical Association

Published: Dec 12, 1994

References