Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Amoxicillin-Potassium Clavulanate Combination; Glucocorticoids; Mometasone Furoate; Prednisone

Criteria

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