Clinical Trial: Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Role of Short Term Systemic Corticosteroid Therapy in the Management of Chronic Rhinosinusitis Without Nasal Polyps

Brief Summary: The purpose of this study is to determine the most effective route to administer steroids to patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with nasal polyps (CRSsNP). The investigators would like to better understand whether orally administered steroids results in superior results when compared with nasally sprayed steroids. The investigators propose to test the hypothesis that for patients with radiographically proven CRSsNP, routine medical therapy consisting of a short course of systemic corticosteroids is superior to topical corticosteroids for relieving inflammation and the symptoms of CRS.

Detailed Summary: Chronic sinus infections (chronic sinusitis or CRS) are common conditions that affect millions of Americans. While this is a common disorder, medical treatments for this condition vary a lot and little is known how and why different treatments work in some individuals and not in others. Some physicians commonly utilize a course of oral steroid therapy similar to treatment of inflammatory conditions including asthma and arthritis. Other physicians feel that oral steroids are not more effective than nasal steroid sprays in reducing inflammation and prefer prescribing nasal steroids. There is no conclusive data as to whether oral or sprayed nasal steroids are more effective in providing long-term benefit to patients. Nasal steroids are FDA approved to treat some types of chronic sinusitis but oral steroids are FDA approved medications that are used to treat inflammatory conditions but is not specifically indicated for chronic sinusitis and thus should be regarded as investigational drug. The purpose of this research study is to better understand whether orally administered steroids results in superior results when compared with nasally sprayed steroids. The investigators will compare patients with chronic sinusitis who are first treated with antibiotics and oral steroids, and compare them to chronic sinusitis patients who receive antibiotics and nasally sprayed steroid therapy.
Sponsor: Northwestern University

Current Primary Outcome: SNOT-22 Questionnaire [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]

Original Primary Outcome: Lund-McKay score from CT scan [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]

Current Secondary Outcome:

• Lund-McKay Score From CT Scan [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]
  Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.
• Taskforce Symptom Inventory [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]
  Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.
• Medication Side-effect and Compliance Inventory [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]
  The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.

Original Secondary Outcome:

• Taskforce Symptom Inventory [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]
  Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.
• SNOT-22 Questionnaire [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]
  Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.
• Medication Side-effect and Compliance Inventory [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ]
  The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.

Information By: Northwestern University

Dates:
Date Received: August 24, 2012
Date Started: August 2012
Date Completion:
Last Updated: March 27, 2017
Last Verified: March 2017