Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps



Status:Completed
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - 80
Updated:3/8/2019
Start Date:August 2015
End Date:January 2019

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The Role of Oral Steroids in the Management of Chronic Rhinosinusitis Without Nasal Polyps

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.

The investigators will compare patients with CRSsNP who are treated with antibiotics/nasal
steroid sprays, and compare them to chronic sinusitis patients who receive antibiotics/nasal
steroid spray along with a course of oral steroids. The goal is to determine if oral steroids
have a role in CRSsNP, and if so, the most effective dosage.

Inclusion Criteria:

1. They have three-months of persistent symptoms meeting criteria for chronic
rhinosinusitis as defined by the taskforce on rhinosinusitis.

2. They have a CT-scan in the clinic or have a viewable recent (< 3 weeks prior to clinic
visit) CT-scan with a Lund Mackay score of 6 or greater. A Lund Mackay score of 6 or
greater is felt to be indicative of at least moderate CRS.

3. They do not have nasal polyps on initial clinic nasal endoscopy

4. They are willing to participate in a clinical study

5. They are between the ages of 18 to 80.

Exclusion Criteria:

1. They have a condition in which the use of systemic corticosteroids is contraindicated
such as diabetes will be excluded.

2. They are unable to or unwilling to take the prescribed antibiotics or steroids will
excluded.

3. They have been treated with a > 3 week course of antibiotics and/or systemic steroids
will also be excluded.

4. They have variants of chronic sinusitis known to be refractory to medical therapy such
as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.

5. They have sinusitis secondary to prior surgery, a dental procedure or anatomical
variants.

6. They have nasal polyps on physical exam.

7. They are pregnant. Subjects who are possibly pregnant will be excluded based on
history. Pregnancy testing is not standard of care for diagnostic imaging.

8. They have a Lund-Mackay score on CT scan of < 6

9. They are < 18 or > 80 years old
We found this trial at
1
site
11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Kristin A Seiberling, MD
Phone: 909-558-2002
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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mi
from
Loma Linda, CA
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