Background: Comparative studies with topical corticosteroids and antihistamines 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 fluticasone propionate aqueous nasal spray (200 mu g 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 fluticasone 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 the place-treated patients has 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.

Triamcinolone acetonide (TAA) Aqueous nasal spray administered once daily has been shown to reduce the symptoms of perennial and seasonal allergic rhinitis. This multicenter, placebo-controlled, double-blind study was designed to determine whether the effects of TAA Aqueous nasal spray are due to topical actions or systemic effects. A total of 297 patients with seasonal allergic rhinitis due to ragweed received either topical TAA Aqueous nasal spray (220 mu g/day), systemic TAA administered orally (275 mu g/day), or placebo once daily for 2 weeks. Effects on rhinitis symptoms were evaluated from daily patient diaries maintained throughout the study. Topical TAA Aqueous nasal spray provided greater (P < 0.05) improvements in all nasal symptoms compared with systemic TAA and placebo. Improvements in rhinitis symptoms occurred as early as the first day of treatment with topical nasal spray. The effects of systemic TAA and placebo on nasal symptoms were statistically similar. All treatments were well tolerated over the 2-week study period. This study demonstrated that the improvements in rhinitis symptoms with TAA Aqueous nasal spray are attributable to its topical actions and not to any systemic effects.

A 1-year, open-label extension of a 12-week, double-blind clinical trial was conducted to evaluate the long-term safety and efficacy of once-daily therapy with triamcinolone acetonide nasal aerosol (110, 220, or 440 micrograms) in 93 patients with perennial allergic rhinitis. All three doses of triamcinolone acetonide were associated with sustained improvement in allergic rhinitis symptoms over the course of 1 year, as evidenced by physicians' and patients' global evaluations, ratings of the nasal environment (appearance and color of the nasal mucosa, as well as the quality of nasal secretions), nasal eosinophil counts, and requirement for escape medication. Among patients who reported adverse clinical experiences, most were considered unrelated or remotely related to therapy. Few patients experienced nasal irritation or throat discomfort, and no serious adverse experiences were attributed to treatment. Among 6 patients who withdrew from the study because of adverse experiences, a possible drug relationship was cited in 2 individuals (1 with headache and 1 with nasal blood) and a remote relationship in 1 (with acne). No clinically meaningful changes in vital signs, physical examinations, or laboratory values were noted, and mean serum cortisol levels were not suppressed during long-term treatment. These findings demonstrate that both safety and efficacy are maintained during long-term once-daily therapy with triamcinolone acetonide nasal aerosol in patients with perennial allergic rhinitis.

A new potent topical corticosteroid, fluticasone propionate aqueous nasal spray, has proved effective when administered twice daily for seasonal allergic rhinitis. The purpose of this study was to compare the efficacy and safety of a once-daily dosage with twice-daily administration of fluticasone propionate. A multicenter, double-blind, randomized, placebo-controlled study was conducted in adults with moderate to severe symptoms of allergic rhinitis during the autumn pollen season. Patients were treated for 4 weeks with fluticasone propionate aqueous nasal spray, 200 μg once daily or 100 μg twice daily or matching placebo. Fluticasone propionate administered once daily in the morning was as effective as the twice-daily dosage regimen, and both regimens were more effective than placebo. Nasal symptoms were improved by the second day of treatment and continued to improve throughout the study. Nasal eosinophils were reduced in more patients treated with either regimen of fluticasone propionate compared with placebo. Adverse events were similar in frequency and nature in all three groups. There was no evidence of hypothalamicpituitary-adrenal axis effects; mean morning plasma cortisol concentrations and response to cosyntropin stimulation remained within normal ranges and were similar across groups. We conclude that fluticasone propionate aqueous nasal spray administered once daily is safe and as effective as a twice-daily dosage regimen for treating seasonal allergic rhinitis.

A randomized, double-blind, placebo-controlled, parallel group study was conducted in 11 centers to evaluate the safety and efficacy of a once-a-day regimen of 110 micrograms, 220 micrograms; and 440 micrograms of triamcinolone acetonide intranasal aerosol versus placebo in relieving the symptoms of rhinitis in 305 adult and older pediatric patients with perennial allergic rhinitis. Nasal stuffiness, nasal discharge, sneezing, nasal itching and the nasal index (the sum of the mean scores of the first three symptoms) averaged over the first 6 weeks and second 6 weeks of the study were significantly reduced in patients who received the 220 micrograms/day and the 440 micrograms/day dosages. The 110 micrograms/day group had a reduction in these nasal symptoms, but only the sneezing and nasal index were significantly (P less than .05) better than placebo. During the last 6 weeks of the study, patients were allowed to take oral back-up medication for their nasal symptoms; all three groups receiving triamcinolone nasal aerosol took less back-up medication than did the placebo group. There were no significant adverse effects or laboratory abnormalities noted during this study. Intranasal triamcinolone acetonide 220 micrograms and 440 micrograms, used once-a-day for 12 weeks is clinically and statistically superior to placebo for the treatment of perennial allergic rhinitis.

BACKGROUND:Topical corticosteroids are widely regarded as the reference standard in allergic rhinitis therapy because they are well tolerated and effective against all rhinitis symptoms. We evaluated the efficacy, onset of action, and safety of two dosing regimens of the new corticosteroid fluticasone propionate compared with that of beclomethasone dipropionate in patients with moderate to severe seasonal allergic rhinitis.METHODS:In this double-blind, randomized multicenter trial, 110 adolescents and 128 adults were treated for 4 weeks with one of the following regimens: fluticasone aqueous nasal spray 100 micrograms twice daily or 200 micrograms once daily, beclomethasone aqueous nasal spray 168 micrograms twice daily, or placebo.RESULTS:Patient-rated scores for nasal obstruction, rhinorrhea, and combined nasal symptoms indicated that the two fluticasone regimens were equally effective and that both were superior to beclomethasone during most of the study (P < or = .05) and to placebo throughout the study (P < or = .01). Both fluticasone regimens also demonstrated significant clinical efficacy by 24 hours after the first dose. Clinician-rated mean total nasal symptoms scores for all three active treatments were superior to placebo at most time points but were not significantly different from each other. All treatments were well tolerated, with similar incidence and type of adverse events in all treatment groups and no apparent effects on hypothalamic-pituitary-adrenal (HPA) axis function.CONCLUSIONS:Fluticasone aqueous nasal spray was effective in relieving nasal symptoms in adolescents and adults with seasonal allergic rhinitis. Fluticasone administered once or twice daily was superior to beclomethasone administered twice daily in relieving nasal obstruction and rhinorrhea and in reducing nasal symptoms more quickly.

In a double-blind study involving 205 patients with perennial allergic rhinitis, statistically significantly greater symptomatic improvements were evident following the administration of 200 micrograms/day triamcinolone acetonide aerosol than following placebo. These improvements were evident as early as week 1 and were sustained throughout the 12-week study. They were accompanied by greater reductions in nasal eosinophils. Triamcinolone acetonide aerosol was well tolerated and had no effect on serum cortisol levels.