Phase 4
Completed N=80
The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis
chronic rhinosinusitis · Chronic Eosinophilic Rhinosinusitis · Allergic Rhinosinusitis
Source: ClinicalTrials.gov NCT02696850 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Change in SNOT-22 (Sino-Nasal Outcome Test) — 20.7; 13.6 score on a scale
◆ Published Evidence
Established
73citations · ~9 / year
Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis: A Randomized Clinical Trial.
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.
Linked Publications
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Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis: A Randomized Clinical Trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT02696850) and the linked publication. 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. Informational only — not medical advice.