Nebulized Nasal Steroids

Summary

The goal of the proposed project is to assess the efficacy, safety, and patient experience of budesonide administered via the NasoNeb system for medical management of CRS. The authors propose a randomized controlled trial of nebulized budesonide via the NasoNeb compared against budesonide lavage.

Timeline

Start

2025-12

Primary completion

2026-05

Completion

2026-05

Publications

• Background Tait S, Kallogjeri D, Suko J, Kukuljan S, Schneider J, Piccirillo JF. Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):605-612. doi: 10.1001/jamaoto.2018.0667.
• Background Orlandi RR, Kingdom TT, Smith TL, Bleier B, DeConde A, Luong AU, Poetker DM, Soler Z, Welch KC, Wise SK, Adappa N, Alt JA, Anselmo-Lima WT, Bachert C, Baroody FM, Batra PS, Bernal-Sprekelsen M, Beswick D, Bhattacharyya N, Chandra RK, Chang EH, Chiu A, Chowdhury N, Citardi MJ, Cohen NA, Conley DB, DelGaudio J, Desrosiers M, Douglas R, Eloy JA, Fokkens WJ, Gray ST, Gudis DA, Hamilos DL, Han JK, Harvey R, Hellings P, Holbrook EH, Hopkins C, Hwang P, Javer AR, Jiang RS, Kennedy D, Kern R, Laidlaw T, Lal D, Lane A, Lee HM, Lee JT, Levy JM, Lin SY, Lund V, McMains KC, Metson R, Mullol J, Naclerio R, Oakley G, Otori N, Palmer JN, Parikh SR, Passali D, Patel Z, Peters A, Philpott C, Psaltis AJ, Ramakrishnan VR, Ramanathan M Jr, Roh HJ, Rudmik L, Sacks R, Schlosser RJ, Sedaghat AR, Senior BA, Sindwani R, Smith K, Snidvongs K, Stewart M, Suh JD, Tan BK, Turner JH, van Drunen CM, Voegels R, Wang Y, Woodworth BA, Wormald PJ, Wright ED, Yan C, Zhang L, Zhou B. International consensus statement on allergy and rhinology: rhinosinusitis 2021. Int Forum Allergy Rhinol. 2021 Mar;11(3):213-739. doi: 10.1002/alr.22741.
• Background Rudmik L. Economics of Chronic Rhinosinusitis. Curr Allergy Asthma Rep. 2017 Apr;17(4):20. doi: 10.1007/s11882-017-0690-5.
• Background Chung SD, Hung SH, Lin HC, Lin CC. Health care service utilization among patients with chronic rhinosinusitis: a population-based study. Laryngoscope. 2014 Jun;124(6):1285-9. doi: 10.1002/lary.24500. Epub 2013 Dec 10.
• Background Bhattacharyya N. Contemporary assessment of the disease burden of sinusitis. Allergy Rhinol (Providence). 2010 Jan 1;1(1):8. doi: 10.2500/ajra.2009.23.3355. No abstract available.
• Background Bhattacharyya N, Orlandi RR, Grebner J, Martinson M. Cost burden of chronic rhinosinusitis: a claims-based study. Otolaryngol Head Neck Surg. 2011 Mar;144(3):440-5. doi: 10.1177/0194599810391852. Epub 2011 Feb 3.
• Background Phillips KM, Hoehle LP, Bergmark RW, Caradonna DS, Gray ST, Sedaghat AR. Acute Exacerbations Mediate Quality of Life Impairment in Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):422-426. doi: 10.1016/j.jaip.2016.09.015. Epub 2016 Nov 7.
• Background Phillips KM, Hoehle LP, Caradonna DS, Gray ST, Sedaghat AR. Minimal clinically important difference for the 22-item Sinonasal Outcome Test in medically managed patients with chronic rhinosinusitis. Clin Otolaryngol. 2018 Oct;43(5):1328-1334. doi: 10.1111/coa.13177. Epub 2018 Jul 26.
• Background Stevens WW, Peters AT, Tan BK, Klingler AI, Poposki JA, Hulse KE, Grammer LC, Welch KC, Smith SS, Conley DB, Kern RC, Schleimer RP, Kato A. Associations Between Inflammatory Endotypes and Clinical Presentations in Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2812-2820.e3. doi: 10.1016/j.jaip.2019.05.009. Epub 2019 May 22.
• Background Chong LY, Head K, Hopkins C, Philpott C, Burton MJ, Schilder AG. Different types of intranasal steroids for chronic rhinosinusitis. Cochrane Database Syst Rev. 2016 Apr 26;4(4):CD011993. doi: 10.1002/14651858.CD011993.pub2.
• Background Joe SA, Thambi R, Huang J. A systematic review of the use of intranasal steroids in the treatment of chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2008 Sep;139(3):340-7. doi: 10.1016/j.otohns.2008.05.628.
• Background Fernandes AM, Valera FC, Anselmo-Lima WT. Mechanism of action of glucocorticoids in nasal polyposis. Braz J Otorhinolaryngol. 2008 Mar-Apr;74(2):279-83. doi: 10.1016/s1808-8694(15)31101-0.
• Background Lee SH. Mechanisms of Glucocorticoid Action in Chronic Rhinosinusitis. Allergy Asthma Immunol Res. 2015 Nov;7(6):534-7. doi: 10.4168/aair.2015.7.6.534. Epub 2015 May 20.
• Background Mastruzzo C, Greco LR, Nakano K, Nakano A, Palermo F, Pistorio MP, Salinaro ET, Jordana M, Dolovich J, Crimi DN, Vancheri C. Impact of intranasal budesonide on immune inflammatory responses and epithelial remodeling in chronic upper airway inflammation. J Allergy Clin Immunol. 2003 Jul;112(1):37-44. doi: 10.1067/mai.2003.1586.
• Background Manji J, Singh G, Okpaleke C, Dadgostar A, Al-Asousi F, Amanian A, Macias-Valle L, Finkelstein A, Tacey M, Thamboo A, Javer A. Safety of long-term intranasal budesonide delivered via the mucosal atomization device for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 May;7(5):488-493. doi: 10.1002/alr.21910. Epub 2017 Feb 2.
• Background Palmer JN, Jacobson KW, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA. EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2018 Jun 1;8(8):869-76. doi: 10.1002/alr.22141. Online ahead of print.
• Background Thamboo A, Manji J, Szeitz A, Santos RD, Hathorn I, Gan EC, Alsaleh S, Javer AR. The safety and efficacy of short-term budesonide delivered via mucosal atomization device for chronic rhinosinusitis without nasal polyposis. Int Forum Allergy Rhinol. 2014 May;4(5):397-402. doi: 10.1002/alr.21280. Epub 2014 Jan 21.
• Background Harvey RJ, Snidvongs K, Kalish LH, Oakley GM, Sacks R. Corticosteroid nasal irrigations are more effective than simple sprays in a randomized double-blinded placebo-controlled trial for chronic rhinosinusitis after sinus surgery. Int Forum Allergy Rhinol. 2018 Apr;8(4):461-470. doi: 10.1002/alr.22093. Epub 2018 Feb 2.
• Background Yoo F, Ference EH, Kuan EC, Lee JT, Wang MB, Suh JD. Evaluation of patient nasal saline irrigation practices following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2018 Jan;8(1):32-40. doi: 10.1002/alr.22034. Epub 2017 Oct 30.
• Background Fox MG, Cass LM, Sykes KJ, Cummings EL, Fassas SN, Nallani R, Smith JB, Chiu AG, Villwock JA. Factors affecting adherence to intranasal treatment for allergic rhinitis: A qualitative study. Laryngoscope Investig Otolaryngol. 2022 Nov 29;8(1):40-45. doi: 10.1002/lio2.986. eCollection 2023 Feb.
• Background Kovacs AJ, Adappa ND, Kuan EC. Exhalation Delivery Systems for Application of Intranasal Corticosteroids. Ear Nose Throat J. 2021 Jun;100(5):309-313. doi: 10.1177/0145561320980194. Epub 2020 Dec 11.
• Background Waniewska-Leczycka M, Cieslik T, Kowalik K, Sierdzinski J, Zagor MP. Comparison of Intranasal Steroid Application Using Nasal Saline Irrigation and a Mucosal Atomization Device to Treat Chronic Rhinosinusitis. J Aerosol Med Pulm Drug Deliv. 2021 Sep;34(5):311-321. doi: 10.1089/jamp.2020.1644. Epub 2021 Apr 13.
• Background Harvey RJ, Goddard JC, Wise SK, Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation. Otolaryngol Head Neck Surg. 2008 Jul;139(1):137-42. doi: 10.1016/j.otohns.2008.04.020.
• Background Hosseini S, Wei X, Wilkins JV Jr, Fergusson CP, Mohammadi R, Vorona G, Golshahi L. In Vitro Measurement of Regional Nasal Drug Delivery with Flonase,(R) Flonase(R) Sensimist, and MAD Nasal in Anatomically Correct Nasal Airway Replicas of Pediatric and Adult Human Subjects. J Aerosol Med Pulm Drug Deliv. 2019 Dec;32(6):374-385. doi: 10.1089/jamp.2019.1523. Epub 2019 Aug 29.
• Background Rotenberg BW. Comparison of Budesonide Delivery Via Nasal Spray and a Nasal Nebulizer to an In Vitro Adult Model. In: TP6. TP006 CLINICAL STUDIES OF ALLERGIC AIRWAY DISEASES, LUPUS, AND EOSINOPHILIC DISEASES.2021:A1338-A1338.
• Background NasoNeb. Particle Size and AIrflow: Implications for Nasal and Paranasal SInus Delivery. https://cdn.shopify.com/s/files/1/0373/3943/1044/files/ParticleSizeAndAirflowInNasalDrugDelivery.pdf?v=1606769959. Accessed 1/2/2025.
• Background Valentine R, Athanasiadis T, Thwin M, Singhal D, Weitzel EK, Wormald PJ. A prospective controlled trial of pulsed nasal nebulizer in maximally dissected cadavers. Am J Rhinol. 2008 Jul-Aug;22(4):390-4. doi: 10.2500/ajr.2008.22.3191.
• Background Nasoneb Information for Physicians and Nurse Practitioners. Monaghan Medical Corporation. https://www.nasoneb.com/pages/physicians-nurse-practitioners. Accessed December 31, 2024.
• Background Manes RP, Tong L, Batra PS. Prospective evaluation of aerosol delivery by a powered nasal nebulizer in the cadaver model. Int Forum Allergy Rhinol. 2011 Sep-Oct;1(5):366-71. doi: 10.1002/alr.20057. Epub 2011 May 9.
• Background BW R. Comparison of Budesonide Delivery Via Nasal Spray and a Nasal Nebulizer to an In Vitro Adult Model. In: TP6. TP006 CLINICAL STUDIES OF ALLERGIC AIRWAY DISEASES, LUPUS, AND EOSINOPHILIC DISEASES.2021:A1338-A1338.
• Background Brown K, Lane J, Silva MP, DeTineo M, Naclerio RM, Baroody FM. A pilot study of the effects of intranasal budesonide delivered by NasoNeb(R) on patients with perennial allergic rhinitis. Int Forum Allergy Rhinol. 2014 Jan;4(1):43-8. doi: 10.1002/alr.21239.
• Background Megow A, Bouras G, Ooi EH, Vreugde S, Psaltis A, Wormald PJ. Double blind randomized controlled trial measuring the efficacy of nebulized steroid at half dose in comparison to high volume squeeze bottle steroid irrigation in management of patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2024 Aug;14(8):1375-1377. doi: 10.1002/alr.23336. Epub 2024 Mar 13.
• Background Wang C, Lou H, Wang X, Wang Y, Fan E, Li Y, Wang H, Bachert C, Zhang L. Effect of budesonide transnasal nebulization in patients with eosinophilic chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2015 Apr;135(4):922-929.e6. doi: 10.1016/j.jaci.2014.10.018. Epub 2014 Dec 4.
• Background Kim KT, Rabinovitch N, Uryniak T, Simpson B, O'Dowd L, Casty F. Effect of budesonide aqueous nasal spray on hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis. Ann Allergy Asthma Immunol. 2004 Jul;93(1):61-7. doi: 10.1016/S1081-1206(10)61448-2.
• Background Smith KA, French G, Mechor B, Rudmik L. Safety of long-term high-volume sinonasal budesonide irrigations for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Mar;6(3):228-32. doi: 10.1002/alr.21700. Epub 2016 Jan 11.

Drugs

Indications