Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
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Purpose
This is a study to evaluate the cause of chronic sinus disease. Oral steroids have long been used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and arthritis. However, it is not well known exactly which patients will benefit from steroids when used in the treatment of chronic sinusitis. For some doctors, it is common practice to use these medications prior to planned sinus surgery, to lessen the inflammation and possibly help the healing process. Other doctors feel oral steroids may not be helpful in this way, and there is no conclusive data as to whether this practice has a long term benefit.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Sinusitis Rhinosinusitis Nasal Polyps |
Drug: Prednisone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Glucocorticosteroid Action in Inflammatory Disease |
- Alterations of inflammatory cells, levels of key antibodies and cytokines, and expression of key epithelial genes [ Time Frame: Prior to surgery and steroid treatment and day of surgery w/ or w/o having been treated w/ steroids ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prednisone
Steroid medication
|
Drug: Prednisone
Prednisone 30mg once daily x 5 days
Other Names:
|
|
No Intervention: No Intervention
No Intervention
|
Detailed Description:
The purpose of this research study is to better understand how this potential treatment option, oral steroids, affects biochemical substances that have been associated with the development of chronic sinusitis and polyps. In order to do this, we need to study people with different forms of chronic sinusitis and compare them to individuals without allergies or sinus disease. We will also look at patients with chronic sinusitis who are treated with oral steroids and compare them to chronic sinus patients who have not received oral steroid therapy prior to surgery. This study may help pave the way to new treatments that address specific parts of the chronic sinus inflammatory pathway.
Hypotheses
- Oral steroid treatment of patients with CRS will lead to a correction in the inflammation that is observed in sinonasal tissues, nasal brushings, and nasal lavage.
- Steroid induced changes in inflammation will differ in chronic sinus patients with polyps than in those without polyps.
- Changes in inflammation will correlate with clinical variables.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Ages 18 years to 70 years
- Diagnosis of chronic rhinosinusitis (CRS) with nasal polyps (NP) and will be undergoing sinonasal surgery for this condition
- Diagnosis of CRS without NP and will be undergoing sinonasal surgery for this condition
- No diagnosis of CRS and NP and will be undergoing nasal surgery (septoplasty/rhinoplasty, nasal fracture repair,etc.)
Exclusion Criteria:
- Ages younger than 18 years and ages older than 70 years
- Diagnosis of an established immunodeficiency, pregnancy, coagulation disorder, a diagnosis of allergic fungal sinusitis (AFS), or cystic fibrosis
- Those with CRS with or without NP in whom systemic steroid therapy would be contraindicated
- Those who are dependent on systemic steroid therapy for sinonasal disease or any other condition
Contacts and Locations| Contact: Robert P Schleimer, Ph.D. | 312-503-0076 | rpschleimer@northwestern.edu |
| Contact: Kathleen E. Harris, B.S. | 312-695-1224 | k-e-harris@northwestern.edu |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Sub-Investigator: Rakesh K Chandra, MD | |
| Sub-Investigator: Robert C Kern, MD | |
| Sub-Investigator: David B Conley, MD | |
| Sub-Investigator: Anju Tripathi-Peters, MD | |
| Sub-Investigator: Leslie Grammer, MD | |
| Principal Investigator: Robert P Schleimer, PhD | |
| Principal Investigator: | Robert P Schleimer, PhD | Northwestern University and Northwestern Memorial Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Robert Schleimer, Professor of Medicine, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00841802 History of Changes |
| Other Study ID Numbers: | STU00010040, 5R37HL068546 |
| Study First Received: | February 9, 2009 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Chronic sinusitis Chronic rhinosinusitis Nasal polyps |
Additional relevant MeSH terms:
|
Nasal Polyps Polyps Sinusitis Chronic Disease Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Paranasal Sinus Diseases Respiratory Tract Infections Disease Attributes |
Pathologic Processes Glucocorticoids Prednisone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013