Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

Completed · Not applicable

Conditions studied: Sinusitis

In brief

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.

Key facts

Study ID

NCT02927834

Run by

Loma Linda University

People needed

24

Starts

2015-08-01

Expected to finish

2019-01-01

Last updated by the study team

2020-12-29

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 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.
• 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-Mackay score on CT scan of < 6
• They are < 18 or > 80 years old

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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