Fluticasone Furoate Nasal Spray Reduces Symptoms of Uncomplicated Acute Rhinosinusitis: a Randomised Placebo-controlled Study

Overview

Journal Prim Care Respir J

Specialties Public Health
Pulmonary Medicine

Date 2012 May 23

PMID 22614920

Citations 7

Authors

Paul K Keith

Andrzej Dymek

Oliver Pfaar

Wytske Fokkens

Suyong Yun Kirby

Wei Wu

Cindy Garris

Nazli Topors

Laurie A Lee

Affiliations

Soon will be listed here.

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.

Citing Articles

A Herbal Formula in the Therapy of Acute Postviral Rhinosinusitis.

Peric A, Gacesa D, Barac A, Peric A Turk Arch Otorhinolaryngol. 2021; 59(1):33-42.

PMID: 33912859 PMC: 8054925. DOI: 10.4274/tao.2020.6098.

Klimek L, Becker S, Buhl R, Chaker A, Huppertz T, Hoffmann T Laryngorhinootologie. 2020; 99(6):356-364.

PMID: 32384572 PMC: 7362395. DOI: 10.1055/a-1164-9696.

Overuse of diagnostic tools and medications in acute rhinosinusitis in Spain: a population-based study (the PROSINUS study).

Jaume F, Quinto L, Alobid I, Mullol J BMJ Open. 2018; 8(1):e018788.

PMID: 29391364 PMC: 5878244. DOI: 10.1136/bmjopen-2017-018788.

Update on Intranasal Medications in Rhinosinusitis.

Snidvongs K, Thanaviratananich S Curr Allergy Asthma Rep. 2017; 17(7):47.

PMID: 28602009 DOI: 10.1007/s11882-017-0720-3.

Diagnosis and Management of Rhinosinusitis: Highlights from the 2015 Practice Parameter.

Dass K, Tripathi Peters A Curr Allergy Asthma Rep. 2016; 16(4):29.

PMID: 26949223 DOI: 10.1007/s11882-016-0607-8.

References

Zalmanovici A, Yaphe J . Steroids for acute sinusitis. Cochrane Database Syst Rev. 2007; (2):CD005149. DOI: 10.1002/14651858.CD005149.pub2. View

Rosenblut A, Bardin P, Muller B, Faris M, Wu W, Caldwell M . Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis. Allergy. 2007; 62(9):1071-7. DOI: 10.1111/j.1398-9995.2007.01521.x. View

Piccirillo J, Merritt Jr M, Richards M . Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002; 126(1):41-7. DOI: 10.1067/mhn.2002.121022. View

Williamson I, Rumsby K, Benge S, Moore M, Smith P, Cross M . Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial. JAMA. 2007; 298(21):2487-96. DOI: 10.1001/jama.298.21.2487. View

Meltzer E, Orgel H, Backhaus J, Busse W, Druce H, Metzger W . Intranasal flunisolide spray as an adjunct to oral antibiotic therapy for sinusitis. J Allergy Clin Immunol. 1993; 92(6):812-23. DOI: 10.1016/0091-6749(93)90058-n. View

Salter M, Biggadike K, Matthews J, West M, Haase M, Farrow S . Pharmacological properties of the enhanced-affinity glucocorticoid fluticasone furoate in vitro and in an in vivo model of respiratory inflammatory disease. Am J Physiol Lung Cell Mol Physiol. 2007; 293(3):L660-7. DOI: 10.1152/ajplung.00108.2007. View

Barlan I, Erkan E, Bakir M, Berrak S, Basaran M . Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children. Ann Allergy Asthma Immunol. 1997; 78(6):598-601. DOI: 10.1016/S1081-1206(10)63223-1. View

Snow V, Hickner J . Principles of appropriate antibiotic use for acute sinusitis in adults. Ann Intern Med. 2001; 134(6):495-7. DOI: 10.7326/0003-4819-134-6-200103200-00016. View

Fokkens W, Lund V, Mullol J . European position paper on rhinosinusitis and nasal polyps 2007. Rhinol Suppl. 2007; 20:1-136. View

10.

Rosenfeld R, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats T . Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007; 137(3 Suppl):S1-31. DOI: 10.1016/j.otohns.2007.06.726. View

11.

Ryan D . Management of acute rhinosinusitis in primary care: changing paradigms and the emerging role of intranasal corticosteroids. Prim Care Respir J. 2008; 17(3):148-55. PMC: 6619892. DOI: 10.3132/pcrj.2008.00050. View

12.

Ahovuo-Saloranta A, Borisenko O, Kovanen N, Varonen H, Rautakorpi U, Williams Jr J . Antibiotics for acute maxillary sinusitis. Cochrane Database Syst Rev. 2008; (2):CD000243. DOI: 10.1002/14651858.CD000243.pub2. View

13.

Meltzer E, Charous B, Busse W, Zinreich S, Lorber R, Danzig M . Added relief in the treatment of acute recurrent sinusitis with adjunctive mometasone furoate nasal spray. The Nasonex Sinusitis Group. J Allergy Clin Immunol. 2000; 106(4):630-7. DOI: 10.1067/mai.2000.109056. View

14.

Meltzer E, Bachert C, Staudinger H . Treating acute rhinosinusitis: comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo. J Allergy Clin Immunol. 2005; 116(6):1289-95. DOI: 10.1016/j.jaci.2005.08.044. View

15.

Dolor R, Witsell D, Hellkamp A, Williams Jr J, Califf R, Simel D . Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis. The CAFFS Trial: a randomized controlled trial. JAMA. 2002; 286(24):3097-105. DOI: 10.1001/jama.286.24.3097. View

16.

Mygind N, Prytz S, Sorensen H, Pedersen C . Long-term treatment of nasal polyps with beclomethasone dipropionate aerosol. I. Treatment and rationale. Acta Otolaryngol. 1976; 82(3-4):252-5. DOI: 10.3109/00016487609120897. View