NCT07270302

Nebulized Nasal Steroids

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Rhinosinusitis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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
COMBINATION_PRODUCT	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

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study