Nebulized Nasal Steroids
ConditionChronic Rhinosinusitis
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- nebulized budesonide via NasoNeb
- budesonide lavage via NeilMed
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov