Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Stopped early · Phase 4

Conditions studied: Chronic Rhinosinusitis Without Nasal Polyps

In brief

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.

Key facts

Study ID

NCT01676415

Run by

Northwestern University

People needed

9

Starts

2012-08-01

Expected to finish

2016-08-01

Last updated by the study team

2018-03-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.
• They do not have nasal polyps on initial clinic nasal endoscopy
• They are willing to participate in a clinical study
• They are between the ages of 18 to 80.

You may not qualify if…

• They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded.
• They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded.
• They have been treated with a > 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-Mckay score on CT scan of < 6
• They are < 18 or > 80 years old

Where it is running

• : Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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