Clinical trial NCT01676415: Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Official title: Role of Short Term Systemic Corticosteroid Therapy in the Management of Chronic Rhinosinusitis Without Nasal Polyps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
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
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: SNOT-22 Questionnaire
timeFrame: 4-6 weeks and 3 months after initiation of treatment
Secondary outcomes:
measure: Lund-McKay Score From CT Scan
timeFrame: 4-6 weeks and 3 months after initiation of treatment
measure: Taskforce Symptom Inventory
timeFrame: 4-6 weeks and 3 months after initiation of treatment
measure: Medication Side-effect and Compliance Inventory
timeFrame: 4-6 weeks and 3 months after initiation of treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: : Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bruce Tan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hissaria P, Smith W, Wormald PJ, Taylor J, Vadas M, Gillis D, Kette F. Short course of systemic corticosteroids in sinonasal polyposis: a double-blind, randomized, placebo-controlled trial with evaluation of outcome measures. J Allergy Clin Immunol. 2006 Jul;118(1):128-33. doi: 10.1016/j.jaci.2006.03.012. Epub 2006 May 19.
citation: Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.
citation: Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
citation: Parikh A, Scadding GK, Darby Y, Baker RC. Topical corticosteroids in chronic rhinosinusitis: a randomized, double-blind, placebo-controlled trial using fluticasone propionate aqueous nasal spray. Rhinology. 2001 Jun;39(2):75-9.
citation: Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42.
citation: Wallwork B, Coman W, Mackay-Sim A, Greiff L, Cervin A. A double-blind, randomized, placebo-controlled trial of macrolide in the treatment of chronic rhinosinusitis. Laryngoscope. 2006 Feb;116(2):189-93. doi: 10.1097/01.mlg.0000191560.53555.08.