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Original Article
February 2001

Absence of Nasal Mucosal Atrophy With Fluticasone Aqueous Nasal Spray

Author Affiliations

From the Section of Otolaryngology–Head and Neck Surgery (Drs Baroody, Cheng, Corey, and Naclerio and Mss deTineo and Haney) and the Department of Pathology (Dr Sengupta), Pritzker School of Medicine, University of Chicago, Chicago, Ill; Department of Medicine (Division of Clinical Immunology), The Johns Hopkins University School of Medicine, Baltimore, Md (Ms Moylan and Dr Togias); and Glaxo Wellcome Inc, Research Triangle Park, NC (Messrs Reed and Westlund and Ms Cook).

Arch Otolaryngol Head Neck Surg. 2001;127(2):193-199. doi:10.1001/archotol.127.2.193

Objective  To evaluate whether 1 year of continuous treatment with intranasal fluticasone propionate would lead to atrophy in the nasal mucosa compared with an active control, oral terfenadine.

Design  Prospective, randomized, multicenter, open-label, parallel-group study.

Setting  Two tertiary care academic institutions.

Patients  Seventy-five subjects older than 18 years with perennial allergic rhinitis.

Interventions  Patients received either fluticasone propionate aqueous nasal spray, 200 µg once daily, or terfenadine, 60 mg twice daily, for 1 year. Nasal biopsy specimens were obtained before and after 1 year of treatment and were evaluated for evidence of atrophy.

Main Outcome Measures  Epithelial and collagen layer thickness of the nasal mucosa as assessed by light microscopy and the presence and degree of edema, and regularity of collagen fibrils as assessed by electron microscopy. Analyses were performed without knowledge of subject identity or treatment assignment.

Results  Neither fluticasone nor terfenadine treatment led to atrophy in the nasal mucosa by clinical or histologic observation. No significant changes from baseline were observed for any assessment of atrophy. In contrast to what would have been expected if atrophy were to occur, mean epithelial layer thickness in the fluticasone group significantly increased compared with terfenadine treatment (P = .03).

Conclusions  Treatment with intranasal fluticasone for 1 year increases the thickness of the nasal epithelium as compared with a year's treatment with terfenadine and does not lead to atrophy in the nasal mucosa. The increased thickness in the fluticasone treatment may represent repair from epithelial damage caused by chronic allergic inflammation.