Ea. Bronsky et al., FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY COMPARED WITH TERFENADINE TABLETS IN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS, Journal of allergy and clinical immunology, 97(4), 1996, pp. 915-921
Background: Comparative studies with topical corticosteroids and antih
istamines for treatment of allergic rhinitis have not always demonstra
ted clear distinctions between the two on the basis of therapeutic eff
icacy. 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), ter
fenadine tablets (60 mg twice daily), or placebo for 4 weeks in a mult
icenter, randomized, double-blind, double-dummy, parallel-group study.
Results: Clinician-rated total nasal symptom scores after 1, 2, 3, an
d 4 weeks of therapy and patient-rated total nasal symptom scores thro
ughout treatment were significantly (p < 0.05) lower in the fluticason
e 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. T
otal nasal airflow, measured by rhinomanometry, significantly (p < 0.0
5) improved in the fluticasone propionate group compared with the terf
enadine group or the placebo group. More fluticasone propionate-treate
d patients compared with the place-treated patients has reduced nasal
mucosal eosinophil counts after 4 weeks of therapy (p < 0.05). No seri
ous or unusual drug-related adverse events were reported. Morning plas
ma cortisol concentrations after 4 weeks of therapy did not differ amo
ng groups. Conclusion: Fluticasone propionate aqueous nasal spray is m
ore effective than terfenadine tablets for treatment of seasonal aller
gic rhinitis.