Current medical research and opinion · 2008
Dose-ranging study of fluticasone furoate nasal spray for Japanese patients with perennial allergic rhinitis*.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Okubo K, Nakashima M, Miyake N, Uchida J, Okuda M
Аннотация
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.
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.