1. Optimal dose selection of fluticasone furoate nasal spray for the treatment of seasonal allergic rhinitis in adults and adolescents.
- Author
-
Martin BG, Ratner PH, Hampel FC, Andrews CP, Toler T, Wu W, Faris MA, and Philpot EE
- Subjects
- Administration, Intranasal, Adolescent, Adult, Androstadienes adverse effects, Androstadienes pharmacokinetics, Anti-Allergic Agents adverse effects, Anti-Allergic Agents pharmacokinetics, Anti-Inflammatory Agents adverse effects, Anti-Inflammatory Agents pharmacokinetics, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Equipment Design, Female, Fluticasone, Humans, Male, Quality of Life, Texas, Time Factors, Treatment Outcome, Androstadienes administration & dosage, Anti-Allergic Agents administration & dosage, Anti-Inflammatory Agents administration & dosage, Nebulizers and Vaporizers, Rhinitis, Allergic, Seasonal drug therapy
- Abstract
Efficacy and safety of fluticasone furoate nasal spray, administered using a unique side-actuated device, were evaluated in patients > or =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 microg (n=127), 110 microg (n=127), 220 microg (n=129), or 440 microg (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 < or = 0.013 each dose versus placebo), and morning predose instantaneous total ocular symptom score (p < or = 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 microg treatment groups (p < or = 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-microg 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.
- Published
- 2007
- Full Text
- View/download PDF