Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)



Status:Terminated
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - 80
Updated:4/17/2018
Start Date:August 2012
End Date:August 2016

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Role of Short Term Systemic Corticosteroid Therapy in the Management of Chronic Rhinosinusitis Without Nasal Polyps

The purpose of this study is to determine the most effective route to administer steroids to
patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with
nasal polyps (CRSsNP). The investigators would like to better understand whether orally
administered steroids results in superior results when compared with nasally sprayed
steroids. The investigators propose to test the hypothesis that for patients with
radiographically proven CRSsNP, routine medical therapy consisting of a short course of
systemic corticosteroids is superior to topical corticosteroids for relieving inflammation
and the symptoms of CRS.

Chronic sinus infections (chronic sinusitis or CRS) are common conditions that affect
millions of Americans. While this is a common disorder, medical treatments for this condition
vary a lot and little is known how and why different treatments work in some individuals and
not in others. Some physicians commonly utilize a course of oral steroid therapy similar to
treatment of inflammatory conditions including asthma and arthritis. Other physicians feel
that oral steroids are not more effective than nasal steroid sprays in reducing inflammation
and prefer prescribing nasal steroids. There is no conclusive data as to whether oral or
sprayed nasal steroids are more effective in providing long-term benefit to patients. Nasal
steroids are FDA approved to treat some types of chronic sinusitis but oral steroids are FDA
approved medications that are used to treat inflammatory conditions but is not specifically
indicated for chronic sinusitis and thus should be regarded as investigational drug. The
purpose of this research study is to better understand whether orally administered steroids
results in superior results when compared with nasally sprayed steroids. The investigators
will compare patients with chronic sinusitis who are first treated with antibiotics and oral
steroids, and compare them to chronic sinusitis patients who receive antibiotics and nasally
sprayed steroid therapy.

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 our clinic or have a viewable recent (< 3weeks prior to clinic
visit) CT-scan with a Lund Mckay score of 6 or greater. A Lund Mckay 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-Mckay score on CT scan of < 6

9. They are < 18 or > 80 years old
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Bruce Tan, MD
Phone: 312-695-0513
?
mi
from
Chicago, IL
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