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Absence of Nasal Mucosal Atrophy With Fluticasone Aqueous Nasal Spray
Fuad M. Baroody;
Cheng-Chou Cheng, MD;
Birgitta Moylan, BSc;
Marcy deTineo, RN;
Lauran Haney, BS;
Kenneth D. Reed, BS;
Cindy K. Cook, MS;
Ronald E. Westlund, MS;
Elizabeth Sengupta, MD;
Jacquelynne P. Corey, MD;
Alkis Togias, MD;
Robert M. Naclerio, MD
Arch Otolaryngol Head Neck Surg. 2001;127:193-199.
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.
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).
Corresponding author and reprints: Fuad M. Baroody, MD, Section of
Otolaryngology–Head and Neck Surgery, University of Chicago, 5841 S
Maryland Ave, MC1035, Chicago, IL 60637 (e-mail: fbaroody{at}surgery.bsd.uchicago.edu).
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