Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

Northwestern University

Status and phase

Withdrawn

Phase 4

Conditions

Rhinosinusitis

Chronic Sinusitis

Nasal Polyps

Treatments

Drug: Prednisone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00841802

5R37HL068546 (U.S. NIH Grant/Contract)

STU00010040

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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