Role of Short Term Systemic Corticosteroid Therapy in the Management of Chronic Rhinosinusitis Without Nasal Polyps
Overview
- Phase
- Phase 4
- Intervention
- Prednisone
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps
- Sponsor
- Northwestern University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- SNOT-22 Questionnaire
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Bruce Tan
MD, Assistant Professor, Dept of Otolaryngology, Northwestern University Feinberg School of Medicine
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Prednisone
Oral steroid medication
Intervention: Prednisone
Topical Mometasone
Topical steroid medication
Intervention: Topical mometasone
Outcomes
Primary Outcomes
SNOT-22 Questionnaire
Time Frame: 4-6 weeks and 3 months after initiation of treatment
The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms ("nasal obstruction" and "loss of smell and taste") ranked from 0 (not a problem) to 5 (problem as bad as it can be). Min score= 0, Max score= 110 ("worst possible problem" on all symptoms) Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.
Secondary Outcomes
- Lund-McKay Score From CT Scan(4-6 weeks and 3 months after initiation of treatment)
- Medication Side-effect and Compliance Inventory(4-6 weeks and 3 months after initiation of treatment)
- Taskforce Symptom Inventory(4-6 weeks and 3 months after initiation of treatment)