Optimal dose selection of fluticasone furoate nasal spray for the treatment of seasonal allergic rhinitis in adults and adolescents
Efficacy and safety of fluticasone furoate nasal spray, administered using a unique side-actuated device, were evaluated in patients ≥12 years of age with seasonal allergic rhinitis to determine the optimal dose. A randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study was performed on 641 patients who received placebo (n = 128) or fluticasone furoate, 55 g (n = 127), 110 g (n = 127), 220 g (n = 129), or 440 g (n = 130), once daily for 2 weeks. Fluticasone furoate was significantly more effective than placebo for mean changes from baseline over the 2-week treatment period in daily reflective total nasal symptom score (primary end point; p < 0.001 each dose vs. placebo), morning predose instantaneous total nasal symptom score (p < 0.001 each dose versus placebo), daily reflective total ocular symptom score (p ≤ 0.013 each dose versus placebo), and morning predose instantaneous total ocular symptom score (p ≤ 0.019 for three highest doses versus placebo). The onset of action for fluticasone furoate nasal spray versus placebo was observed 8 hours after the first dose of study medication in the 110 and 440 g treatment groups (p ≤ 0.032). The incidence of adverse events, results of clinical laboratory tests, and changes in 24-hour urinary cortisol values were similar between active treatment groups and placebo. The preliminary profile of fluticasone furoate is that of a rapidly effective therapy that confers 24-hour efficacy for both nasal and ocular symptoms with once-daily dosing. The 110-g dose was chosen for phase III development because it achieved statistically significant and clinically meaningful results for all efficacy end points and provided the optimal risk–benefit ratio.
Document Type: Research Article
Southwest Allergy and Asthma Research, San Antonio, Texas
Sylvana Research Associates, San Antonio, Texas
Central Texas Health Research, New Braunfels, Texas
Diagnostics Research Group, San Antonio Texas
GlaxoSmithKline, Research Triangle Park, North Carolina
Publication date: March 1, 2007
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Allergy and Asthma Proceedings
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