Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis

Phase 2 Completed 741 enrolled GlaxoSmithKline

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).

Timeline

Start: 2010-01-06
Primary completion: 2010-07-01
Completion: 2010-07-16

Outcome

Met primary endpoint

registry Placebo vs FFNS 110 mcg QD; p = 0.008; Least Squares Mean Difference -0.386 (95% CI -0.67 to -0.10); ANCOVA NCT01018030 ↗

registry Placebo vs FFNS 110 mcg BD; p = 0.014; Least Squares Mean Difference -0.357 (95% CI -0.64 to -0.07); ANCOVA NCT01018030 ↗

Publications

Background Keith PK, Dymek A, Pfaar O, Fokkens W, Yun Kirby S, Wu W, Garris C, Topors N, Lee LA. Fluticasone furoate nasal spray reduces symptoms of uncomplicated acute rhinosinusitis: a randomised placebo-controlled study. Prim Care Respir J. 2012 Sep;21(3):267-75. doi: 10.4104/pcrj.2012.00039.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone Furoate	Other / unclassified	110 ug	Intranasal