Nebulized Nasal Steroids for Chronic Rhinosinusitis

This study is testing two ways to deliver budesonide, a steroid medication, for chronic rhinosinusitis (ongoing inflammation of the nose and sinuses). You would receive either nebulized budesonide using the NasoNeb device or budesonide lavage using a NeilMed bottle. The goal is to see how well each method works, if they are safe, and what your experience is like. We are looking for 50 adults, aged 18 or older, who have been diagnosed with chronic rhinosinusitis based on specific symptoms like nasal blockage, runny nose, reduced smell, or facial pain/pressure. Success in this study will be measured by changes in your Sino-Nasal Outcome Test (SNOT-22) score after 6 weeks. The current status of this study is unclear.

Study design: This is a randomized controlled trial comparing two ways to deliver budesonide, with a planned enrollment of 50 participants.
What's involved: You would be provided with either a NasoNeb machine or a NeilMed lavage bottle, and a 42-day supply of budesonide packets to use twice daily. You will be shown how to use the device and given written instructions and video tutorials.
Compensation: Not stated in the trial record.
Follow-up: Your Sino-Nasal Outcome Test (SNOT-22) score will be measured at week 6.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Nebulized Nasal Steroids

Not Yet Recruiting

PHASE1Ages 18+InterventionalTreatment

Washington University School of Medicine

~50 participants

Updated 2025-12-08 on ClinicalTrials.gov

What's tested:nebulized budesonide via NasoNebbudesonide lavage via NeilMed

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Sino-Nasal Outcome Test (SNOT-22)

Measured over week 6

Conditions

Chronic Rhinosinusitis

Where it's being run

1 sites across 1 states

Missouri1

Study leadership

Nyssa Farrell, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Nyssa Farrell, MD

[email protected]

314-362-7509

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

Sino-Nasal Outcome Test (SNOT-22)week 6
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.

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