Dose-ranging study of fluticasone furoate nasal spray for Japanese patients with perennial allergic rhinitis*.

BACKGROUND

This study was designed to evaluate the efficacy and safety of fluticasone furoate nasal spray (FFNS), a novel enhanced-affinity intranasal corticosteroid, in Japanese patients with perennial allergic rhinitis (PAR), and to determine the optimal dose.

METHODS

In this phase II, multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose-ranging study, 240 patients (aged >or= 16 years) received once-daily (od) treatment for 2 weeks with either FFNS 110 microg (n = 80), 220 microg (n = 81) or placebo (n = 79). Patients evaluated 3 nasal symptoms using a 4-point scale. Efficacy was assessed as the mean change from baseline in total nasal symptom score (TNSS).

RESULTS

Treatment with FFNS resulted in a significantly greater decrease over the treatment period in the mean 3TNSS (sneezing, rhinorrhea, and nasal congestion; p < 0.001 each dose vs. placebo), compared with placebo. More patients receiving FFNS had a markedly or moderately improved impression of treatment than placebo recipients (48% and 49% for FFNS 110 micro and 220 microg, respectively, vs. 18% for placebo; p < 0.001). Nasal rhinoscopy findings revealed significant improvements in mucosal swelling of the inferior turbinate (110 microg: p = 0.004; 220 micro: p = 0.011) and amount of watery rhinorrhea (110 microg: p = 0.003; 220 microg: p < 0.001), compared with placebo. Both doses of FFNS were well tolerated.

CONCLUSIONS

Both FFNS 110 microg and 220 microg od were effective in alleviating nasal symptoms in Japanese patients with PAR over the 2-week duration of this study. FFNS 110 microg od was selected as the optimal dose for further evaluation in phase III clinical trials.