Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/8/2018 |
| Start Date: | July 2008 |
| End Date: | December 31, 2019 |
Glucocorticosteroid Action in Inflammatory Disease
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.
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.
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
1. 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.
2. Steroid induced changes in inflammation will differ in chronic sinus patients with
polyps than in those without polyps.
3. Changes in inflammation will correlate with clinical variables.
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
1. 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.
2. Steroid induced changes in inflammation will differ in chronic sinus patients with
polyps than in those without polyps.
3. Changes in inflammation will correlate with clinical variables.
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
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