Optimal dose selection of fluticasone furoate nasal spray for the treatment of seasonal allergic rhinitis in adults and adolescents.

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.

• Authors: Bruce G Martin, Paul H Ratner, Frank C Hampel, Charles P Andrews, Tom Toler, Wei Wu, Melissa A Faris, Edward E Philpot
• Journal: Allergy and asthma proceedings (Allergy Asthma Proc) 2007 Mar-Apr Vol. 28 Issue 2 Pg. 216-25 ISSN: 1088-5412 [Print] United States
• PMID: 17479608 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Androstadienes
• Anti-Allergic Agents
• Anti-Inflammatory Agents
• Fluticasone

Topics

• Administration, Intranasal
• Adolescent
• Adult
• Androstadienes (administration & dosage, adverse effects, pharmacokinetics)
• Anti-Allergic Agents (administration & dosage, adverse effects, pharmacokinetics)
• Anti-Inflammatory Agents (administration & dosage, adverse effects, pharmacokinetics)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Equipment Design
• Female
• Fluticasone
• Humans
• Male
• Nebulizers and Vaporizers
• Quality of Life
• Rhinitis, Allergic, Seasonal (drug therapy)
• Texas
• Time Factors
• Treatment Outcome