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

Completed · Phase 4 · Has a placebo group

Conditions studied: Rhinosinusitis, Chronic Eosinophilic Rhinosinusitis, Allergic Rhinosinusitis

In brief

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.

Key facts

Study ID

NCT02696850

Run by

Washington University School of Medicine

People needed

80

Starts

2016-01-01

Expected to finish

2017-04-13

Last updated by the study team

2019-09-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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