N/A
N=24
Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT02927834 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Sinonasal Outcome Test (SNOT 20) — 50.33; 53.14; 37 Score out of total 100
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 6 day Prednisone (Drug); Augmentin (Drug); 21 day Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sinonasal Outcome Test (SNOT 20) |
50.33; 53.14; 37 | — |
| PRIMARY Nasal Endoscopy |
2.55; 3.00; 2.16 | — |
| PRIMARY CT Scan Changes |
10.33; 11; 11.83 | — |
Summary
Chronic rhinosinusitis is a common disease that effects millions of people world wide. Despite its frequency it is unclear what treatment options are the best for these patients. Typically patients with chronic rhinosinusitis without nasal polyps (CRSsNP) are given a long term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and occasionally oral steroids. Oral steroids benefit patients with chronic rhinosinusitis with nasal polyps (CRSwNP) however their role in non polyp patients is less clear. It is the goal of this study to see if oral steroids benefit the treatment outcomes in those patients with chronic rhinosinusitis without nasal polyps. In addition this study will look to see if a short course (5 day burst) versus a longer course (21 day taper) of oral steroids make a difference in outcomes.
Eligibility Criteria
Inclusion Criteria
- They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the taskforce on rhinosinusitis.
- They have a CT-scan in the clinic or have a viewable recent ( 3 week course of antibiotics and/or systemic steroids will also be excluded.
- They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.
- They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants.
- They have nasal polyps on physical exam.
- They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging.
- They have a Lund-Mackay score on CT scan of 80 years old
Data sourced from ClinicalTrials.gov (NCT02927834). 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.