Fluticasone furoate nasal spray reduces symptoms of uncomplicated acute rhinosinusitis: a randomised placebo-controlled study

Abstract

Background: Uncomplicated acute rhinosinusitis (ARS) is usually a self-limiting inflammatory condition often treated with antibiotics.

Aims: To assess the safety and efficacy of fluticasone furoate nasal spray (FFNS) compared with placebo for symptomatic relief of uncomplicated ARS.

Methods: A randomised, double-blind, placebo-controlled, parallel-group, multicentre, 2-week treatment study of FFNS 110 μg once and twice daily was undertaken in adults/adolescents.

Results: A statistically significant reduction was seen in the daily major symptoms score, a composite score of three individual symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip on a 0-3 scale) by both FFNS doses compared with placebo (least square mean differences vs. placebo of -0.386 (p=0.008) and -0.357 (p=0.014) for once daily and twice daily FFNS, respectively). The differences in median times to symptom improvement were not statistically significant between each dose of FFNS (7 days) and placebo (8 days). There were no treatment differences in antibiotic use for possible fulminant bacterial rhinosinusitis (3% in each group). The safety profile of FFNS was similar to placebo.

Conclusions: FFNS reduces symptoms of uncomplicated ARS compared with placebo and is well tolerated, providing support for withholding antibiotics in selected patients.

Conflict of interest statement

PKK has received rhinitis-related research funding from GlaxoSmithKline, Merck, Nycomed, Allergy Therapeutics and Allergopharma. He has served on an advisory board for GlaxoSmithKline, Merck, Nycomed and received speakers' honoraria from GlaxoSmithKline, Merck, and Nycomed for rhinitis-related talks. AD has received research funding from Altana/Nycomed, Astra Zeneca, Bohringer Ingelheim, Chesi, Encorium, Fujisawa, GlaxoSmithKline, Hexal, LEK, Mudipharma, Pfizer, and UCB. OP has received research grants from ALK-Abello, Denmark; Allergopharma, Germany; Stallergenes, France; HAL, The Netherlands; Artu Biologicals, The Netherlands; Allergy-Therapeutics/Bencard, UK/Germany; Hartington, Spain; Lofarma, Italy; Novartis/Leti, Germany/Spain; GlaxoSmithKline, UK/Germany; Essex-Pharma, Germany; Cytos, Switzerland; Curalogic, Denmark; Roxall, Germany. He has also served as advisor and on the speakers' bureaus for some of the abovementioned pharmaceutical companies. WF has received research grants from GlaxoSmithKline, Stallargens, Medtronic, HAL, and Optinose. She has served on advisory boards for GlaxoSmithKline, MSD, and Stallargens and on speakers bureaus for GlaxoSmithKline, MSD, Stallargens, and Medtronics. SYK, WW, NT, CG, and LAL are full-time employees of GlaxoSmithKline and own stock in the company.

Figures

Figure 1. Study schematic. BD=twice daily, OD=once daily.

Figure 2. Study population. BD=twice daily, OD=once daily

Figure 3. Least squares mean (SE) change from baseline in daily major symptom score (MSS) during the 2-week treatment period. BD=twice daily, OD=once daily, FFNS, fluticasone furoate nasal spray