Clinical trial NCT01676415
Conditions: Chronic Rhinosinusitis Without Nasal Polyps
Keywords: Sinus disease Sinonasal complaints Chronic sinusitis Nasal polyps Chronic rhinosinusitis without nasal polyps Glucocorticoids Prednisone Topical mometasone Anti-inflammatory agents
Sponsor: Northwestern University
Start date: 2012-08-01; Completion date: 2016-08-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 description:
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.

Arms: arm 1: Oral steroid medication arm 2: Topical steroid medication
Interventions: intervention 1: Prednisone intervention 2: Topical mometasone
Intervention descriptions: intervention 1: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days

Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study intervention 2: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.

Protocol documents: