Safety and Efficacy of Nebulized Nasal Steroids for the Treatment of Chronic Rhinosinusitis
Washington University School of Medicine
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.
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 su…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Patients who have previously undergone sinus surgery * Severe polyposis; defined as Lund Kennedy endoscopy score greater than 1 * Patients who are current…
Interventions
- Combination Productnebulized 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 Productbudesonide 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
Location
- Nyssa Fox FarrellSt Louis, Missouri