Nebulized Nasal Steroids

NCT07270302 | Not Yet Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: 202503084
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Rhinosinusitis

Keywords

Otolaryngology; Pharmacology; Pharmacy; intranasal steroid sprays

Outcome Measures

Primary Outcomes (1)

• Sino-Nasal Outcome Test (SNOT-22)

  SNOT-22 is a 22-question survey designed to measure the physical, functional, and emotional consequences of rhinosinusitis. It contains questions regarding symptoms commonly associated with sinonasal disease. Subjects rate each question by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT-22 total score ranges from a minimum score of 0 to a maximum score of 110, with higher scores representing worse outcome. 9 point difference in SNOT-22 reduction is defined as the minimally clinically important improvement.

  week 6

Secondary Outcomes (4)

• Lund-Kennedy scores

  week 6

• cosyntropin stimulation

  week 6

• Clinical Global Impression - Improvement (CGI-I)

  week 3 and week 6

• Sino-Nasal Outcome Test (SNOT-22)

  week 3

Study Arms (2)

nebulizer group

EXPERIMENTAL

Subjects in the nebulizer group will be prescribed a 42-day supply of 0.5 mg budesonide packets, to be used twice daily without any concomitant saline lavage.

Combination Product: nebulized budesonide via NasoNeb

budesonide lavage group

ACTIVE COMPARATOR

Subjects in the budesonide lavage group will be prescribed 42-day supply of 0.5 mg budesonide packets to be administered via 240 mL twice daily nasal saline lavage.

Combination Product: budesonide lavage via NeilMed

Interventions

nebulized budesonide via NasoNeb COMBINATION_PRODUCT

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

nebulizer group

budesonide lavage via NeilMed COMBINATION_PRODUCT

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

budesonide lavage group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Nyssa Fox Farrell

St Louis, Missouri, 63122, United States

Location

Related Publications (35)

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• 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.

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  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

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  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.

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  PMID: 26750509 BACKGROUND

Study Officials

• Nyssa Farrell, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nyssa Farrell, MD

CONTACT

314-362-7509; nyssa.farrell@wustl.edu

Sara Kukuljan

CONTACT

314-362-7563; kukuljas@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study coordinators will be blinded to treatment arm during data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)