Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Condition: Chronic Rhinosinusitis Without Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Intervention: Prednisone; Topical mometasone
Intervention description: 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; 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.
Intervention MeSH terms: Mometasone Furoate; Prednisone; Glucocorticoids
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Sinus disease; Sinonasal complaints; Chronic sinusitis; Nasal polyps; Chronic rhinosinusitis without nasal polyps; Glucocorticoids; Prednisone; Topical mometasone; Anti-inflammatory agents

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. They have three-months of persistent symptoms meeting criteria for chronic
             rhinosinusitis as defined by the Taskforce on Rhinosinusitis.

          2. They have a CT-scan in our clinic or have a viewable recent (< 3weeks prior to clinic
             visit) CT-scan with a Lund Mckay score of 6 or greater. A Lund Mckay score of 6 or
             greater is felt to be indicative of at least moderate CRS.

          3. They do not have nasal polyps on initial clinic nasal endoscopy

          4. They are willing to participate in a clinical study

          5. They are between the ages of 18 to 80.

        Exclusion Criteria:

          1. They have a condition in which the use of systemic corticosteroids is contraindicated
             such as diabetes will be excluded.

          2. They are unable to or unwilling to take the prescribed antibiotics or steroids will
             excluded.

          3. They have been treated with a > 3 week course of antibiotics and/or systemic steroids
             will also be excluded.

          4. They have variants of chronic sinusitis known to be refractory to medical therapy such
             as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.

          5. They have sinusitis secondary to prior surgery, a dental procedure or anatomical
             variants.

          6. They have nasal polyps on physical exam.

          7. They are pregnant. Subjects who are possibly pregnant will be excluded based on
             history. Pregnancy testing is not standard of care for diagnostic imaging.

          8. They have a Lund-Mckay score on CT scan of < 6

          9. They are < 18 or > 80 years old