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

ABSTRACT

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 ≥ 16 years) received once-daily (od) treatment for 2 weeks with either FFNS 110 μg (n = 80), 220 μg (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 μg and 220 μg, respectively, vs. 18% for placebo; p < 0.001). Nasal rhinoscopy findings revealed significant improvements in mucosal swelling of the inferior turbinate (110 μg: p = 0.004; 220 μg: p = 0.011) and amount of watery rhinorrhea (110 μg: p = 0.003; 220 μg: p < 0.001), compared with placebo. Both doses of FFNS were well tolerated.

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

Key words: :

• Fluticasone furoate nasal spray
• Intranasal corticosteroids
• Nasal symptoms
• Perennial allergic rhinitis

Acknowledgements

Declaration of interest: This study was funded by GlaxoSmithKline K.K. Japan. KO acted as a consultant and medical advisor for this study, MN and MO acted as consultants for this study. NM and JU are employees of GlaxoSmithKline K.K.

Data presented in this article corresponds with the GSK study identifier FFR100650. The following clinics (where the study was conducted) are thanked for their participation: ToCROM Clinic, Oak Tower Clinic and Shinanozaka Clinic. The authors also thank the GlaxoSmithKline FFR100650 study team for their contribution to this study, and Susan Cheer, PhD, and Sian Kneller, MSc, of Innovex Medical Communications for writing assistance and manuscript management.

Notes

* Results were previously presented (abstract and poster format) at the Annual Meeting of the Japanese Society of Allergology, 1–3 Nov 2007, Yokohama, Japan