Nebulized Nasal Steroids

Официальное название

Safety and Efficacy of Nebulized Nasal Steroids for the Treatment of Chronic Rhinosinusitis

Обзор

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.

Подробное описание

Chronic rhinosinusitis is primarily an inflammatory disorder affecting up to 1 in 8 individuals and causing economic burden of greater than 13 billion USD. The NasoNeb is FDA approved for the nasal administration of medications; however, it has been scarcely studied in the existing literature. Many patients are intolerant of or non-compliant with other modalities of nasal steroid administration, and the NasoNeb represents a potential new treatment method for these patients.

Participants will be provided with either a NasoNeb machine or NeilMed lavage bottle, and a prescription for a 42-day supply of 0.5 mg budesonide packets, to be used twice daily. For the NasoNeb, each dose will be dissolved in 10 mL saline with 5 mL nebulized solution being applied to each nasal cavity. This dose was chosen given the historical evidence of efficacy of budesonide 0.5mg daily application via saline lavage.

For the lavage, each budesonide dose will be dissolved in 240 mL saline. Participants will be shown proper use of the NasoNeb machine or lavage bottle at the time of enrollment and be given written instructions with links to video tutorials.

Вмешательства

• Комбинированный продукт nebulized budesonide via NasoNeb
  For the nebulization group, each dose will be dissolved in 10 mL saline with 5 mL nebulized solution being applied to each nasal cavity. Device: NasoNeb
• Комбинированный продукт budesonide lavage via NeilMed
  For the lavage group, each dose will be dissolved in 240 mL saline and 120 mL of the solution will be administered to each nasal cavity. Device: NeilMed

Первичные конечные точки

• Sino-Nasal Outcome Test (SNOT-22) [Срок оценки: week 6]

Вторичные конечные точки (4)

• Lund-Kennedy scores [Срок оценки: week 6]
• cosyntropin stimulation [Срок оценки: week 6]
• Clinical Global Impression - Improvement (CGI-I) [Срок оценки: week 3 and week 6]
• Sino-Nasal Outcome Test (SNOT-22) [Срок оценки: week 3]

Критерии участия

Критерии включения

• Age 18 or older that meet diagnostic criteria for CRS with or without polyposis as documented by their recruiting physician.
• Diagnostic criteria for CRS will be defined according to EPOS criteria of >12 weeks of 2 of the following subjective symptoms: nasal blockage or obstruction, rhinorrhea, hyposmia, or facial pain/pressure AND objective evidence of CRS on either nasal endoscopy or CT scan

Критерии исключения

• Patients who have previously undergone sinus surgery
• Severe polyposis; defined as Lund Kennedy endoscopy score greater than 1
• Patients who are currently using or who have previously used biologic medications for their nasal polyps. These medications include: dupilumab, omalizumab, mepolizumab, tezepelumab, or depemokimab
• Inability to complete surveys in English
• known comorbid mucociliary disease
• known adrenal disease or other HPA dysfunction
• patients taking oral corticosteroids for other medical conditions
• oral antibiotic administration within 2 weeks of study participation
• a baseline SNOT-22 score less than 9, due to inability to achieve the MCID

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Nyssa Fox Farrell — St Louis

Публикации

• 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. PMID 29879268
• 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, Harv PMID 33236525
• Rudmik L. Economics of Chronic Rhinosinusitis. Curr Allergy Asthma Rep. 2017 Apr;17(4):20. doi: 10.1007/s11882-017-0690-5. PMID 28337570
• 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. PMID 24338913
• 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. PMID 28569228
• 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. PMID 21493210
• 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. PMID 27839750
• 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. PMID 29953729

Идентификаторы

NCT: NCT07270302 · 202503084

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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