Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

Phase 4

Withdrawn

• Conditions: Rhinosinusitis; Nasal Polyps; Chronic Sinusitis
• Interventions: Drug: Prednisone

• Registration Number: NCT00841802
• Lead Sponsor: Northwestern University

Brief Summary

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.

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

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone	Prednisone	Steroid medication

Primary Outcome Measures

Name	Time	Method
Alterations of inflammatory cells, levels of key antibodies and cytokines, and expression of key epithelial genes	Prior to surgery and steroid treatment and day of surgery w/ or w/o having been treated w/ steroids

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States