A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology

Allergy and Asthma Medical Group and Research Center, San Diego, CA 92123.
Journal of Allergy and Clinical Immunology (Impact Factor: 11.48). 09/1990; 86(2):221-30. DOI: 10.1016/S0091-6749(05)80069-7
Source: PubMed


Fluticasone propionate is a new glucocorticosteroid with potent topical activity. In a double-blind, randomized, parallel-group study, 423 adult patients with moderate to severe seasonal allergic rhinitis received placebo or fluticasone propionate aqueous nasal spray at doses of 25, 100, or 400 micrograms twice daily (b.i.d.) for 2 weeks. Efficacy was evaluated by nasal symptom scores, nasal airflow, nasal cytology, and global evaluation. All doses of fluticasone propionate were significantly better than placebo in reducing symptoms of seasonal allergic rhinitis. Patients receiving the largest dose of fluticasone propionate (400 micrograms b.i.d.) had a slightly greater reduction (not significant) in symptom scores than patients receiving the smallest dose (25 micrograms b.i.d.). Symptom improvement was evident within 3 days of treatment. Nasal airflow improved in the groups treated with fluticasone propionate, 100 and 400 micrograms b.i.d. Examination of nasal cytograms revealed a striking decrease in both eosinophils and basophils in all three groups receiving active treatment compared with placebo. There were few adverse events and no treatment-related abnormalities in laboratory assays or evaluations of hypothalamo-pituitary-adrenocortical axis function. Comparison of treatment groups indicated that fluticasone propionate aqueous nasal spray was as safe as placebo at the doses studied.

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    • "1980s the drug was reformulated to contain less propylene glycol (Nasarel®) which resulted in a significantly lower frequency of nasal burning and stinging as well as throat irritation (Greenbaum et al., 1988; Meltzer et al., 1990). Hence, a screening method for clinical discomfort would be very helpful in the development and refinement process of formulations which are usually tolerated well. "
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    • "Several large, double-blind, placebo-controlled studies have established the clinical efficacy of FP in SAR. An initial dose-ranging study established that 25 μg, 100 μg and 400 μg given on a twice-daily regime had superior clinical efficacy compared to placebo and this was evident as early as 3 days into dosing.30 Subsequent studies evaluated clinical efficacy and the further safety of FP. "
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    • "The effectiveness of intranasal corticosteroid therapy in allergic rhinitis has been proven in controlled trials (Meltzer et al., 1990; Godthelp et al., 1996). Also, a significant effect has been demonstrated in patients with nasal polyposis (Chalton et al., 1985; Lidholt et al., 1995; Lund et al., 1998). "
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