The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

• Status: Completed
• Trial end date: 2017-04-13
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this research project is to explore the impact of the addition of budesonide to high-volume, low-pressure nasal sinus saline irrigation (aka "Neti-Pot"-type systems) for patients with chronic rhinosinusitis with or without nasal polyps.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Budesonide

Criteria

Inclusion Criteria:

Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS)

• mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion),facial pain-pressure-fullness, and decreased sense of smell

AND inflammation documented by one or more of the following findings:

• purulent (not clear) mucus or edema in the middle meatus or ethmoid region,

• polyps in nasal cavity or the middle meatus, and/or

• radiographic imaging showing inflammation of the paranasal sinuses

Exclusion Criteria:

• Unable to speak English

• History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition

• Dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease.

• History of oral or systematic antibiotic use in the past 2 weeks

• History of nasal or sinus surgery within past 6 weeks

• History of cerebrospinal fluid leak

• History of allergy to budesonide or other topical steroids

• Pregnant or breast feeding

• Current infection or history of one of the following infections: Tuberculosis (TB) lung infection, or Herpes infection of the eye.

• Baseline SNOT-22 total scores below 9 were excluded due to the inability to achieve a minimally clinically improved difference