Nebulized Nasal Steroids

Conditions

• Chronic Rhinosinusitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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
• 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

Study Details

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.

Key Dates

Start date

Dec 31, 2025

Status verified

Nov 2025

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: nebulizer group
  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.
• Active Comparator: budesonide lavage group
  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.

Primary Outcome Measure

Sino-Nasal Outcome Test (SNOT-22) [ Time Frame: week 6 ]

Central Contacts

• Nyssa Farrell, MD
  314-362-7509
  [email protected]
• Sara Kukuljan
  314-362-7563
  [email protected]

Locations (1)

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