Phase 4 N=80 Randomized Double-blind Treatment

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

Rhinosinusitis · Chronic Eosinophilic Rhinosinusitis · Allergic Rhinosinusitis

Bottom Line

View on ClinicalTrials.gov: NCT02696850 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Change in SNOT-22 (Sino-Nasal Outcome Test) — 20.7; 13.6 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Budesonide (Drug); Saline alone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in SNOT-22 (Sino-Nasal Outcome Test)	20.7; 13.6	—
SECONDARY Clinical Global Impression of Change (CGI)	24; 20	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02696850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.