Comparison of fluticasone furoate and fluticasone propionate for the treatment of Japanese cedar pollinosis.
Fluticasone furoate nasal spray (FFNS) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the treatment of allergic rhinitis. No previous clinical studies have compared the efficacy of FFNS with another intranasal steroid. The purpose of this study was to compare the efficacy and safety of FFNS, 110 microg/day, once daily with fluticasone propionate nasal spray (FPNS), 200 microg/day, twice daily in patients with Japanese cedar pollinosis to support the regulatory filing in Japan. In this multicenter, randomized, placebo-controlled, double-blind, parallel-group study, patients (>or=16 years old) were randomized to receive 2 weeks of treatment with FFNS (n = 151), FFNS placebo (n = 72), FPNS (n = 148), or FPNS placebo (n = 75). FFNS once daily was noninferior to FPNS twice daily in mean change from baseline in three total nasal symptom scores (3TNSS; sneezing, rhinorrhea, and nasal congestion; -1.23 +/- 0.140 and -1.06 +/- 0.142, respectively). Compared with placebo, FFNS was superior in reducing 3TNSS (p < 0.001). Both FFNS and FPNS showed similar mean changes from baseline in 4TNSS (3TNSS and nasal itching) and individual nasal symptom scores. The onset of action for FFNS was observed from the 1st day of treatment, whereas in the FPNS group it was observed on the 2nd day. There were similar improvements in rhinoscopy findings, activity of daily life interference, and patient-rated overall evaluation to therapy in the FFNS and FPNS groups. FFNS was well tolerated. Treatment with once-daily FFNS was effective and noninferior to twice-daily FPNS in reducing nasal symptoms. Faster onset of action for FFNS was observed.
Okubo
Kimihiro
K
Department of Otorhinolaryngology, Nippon Medical School, 1-1-5 Sendagi Bunko-yu, Tokyo 113-8603, Japan. ent-kimi@nms.ac.jp
Nakashima
Mitsuyoshi
M
Miyake
Noboru
N
Komatsubara
Masaki
M
Okuda
Minoru
M
D000281:Administration, Intranasal; D000328:Adult; D000368:Aged; D000485:Allergens / Q000276:immunology; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D032485:Cryptomeria / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D015508:Nasal Obstruction / Q000517:prevention & control; D011058:Pollen / Q000276:immunology; D011537:Pruritus / Q000517:prevention & control; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D012912:Sneezing / Q000187:drug effects
D000485:Allergens; D000730:Androstadienes; D006634:Histamine H1 Antagonists; D000068298:Fluticasone; C523187:fluticasone furoate