This trial is active, not recruiting.

Conditions chronic sinusitis, rhinosinusitis, nasal polyps
Treatment prednisone
Phase phase 4
Sponsor Northwestern University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date July 2008
End date December 2016
Trial size 50 participants
Trial identifier NCT00841802, 5R37HL068546, STU00010040


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Steroid medication
prednisone Glucocorticoid
Prednisone 30mg once daily x 5 days
(No Intervention)
No Intervention

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Glucocorticosteroid Action in Inflammatory Disease
Principal investigator Robert P Schleimer, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Northwestern University.