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Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Primary Purpose

Chronic Rhinosinusitis Without Nasal Polyps

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisone
Topical mometasone
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis Without Nasal Polyps focused on measuring Sinus disease, Sinonasal complaints, Chronic sinusitis, Nasal polyps, Chronic rhinosinusitis without nasal polyps, Glucocorticoids, Prednisone, Topical mometasone, Anti-inflammatory agents

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • : Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prednisone

Topical Mometasone

Arm Description

Oral steroid medication

Topical steroid medication

Outcomes

Primary Outcome Measures

SNOT-22 Questionnaire
The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms ("nasal obstruction" and "loss of smell and taste") ranked from 0 (not a problem) to 5 (problem as bad as it can be). Min score= 0, Max score= 110 ("worst possible problem" on all symptoms) 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.

Secondary Outcome Measures

Lund-McKay Score From CT Scan
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
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
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.

Full Information

First Posted
August 24, 2012
Last Updated
March 28, 2018
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01676415
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
participants are no longer receiving intervention due to clinical logistics
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
Oral steroid medication
Arm Title
Topical Mometasone
Arm Type
Active Comparator
Arm Description
Topical steroid medication
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Glucocorticoid, Deltasone, Liquid Pred, Meticorten, Orasone, Prednicen-M, Prednicot, Sterapred, Sterapred DS
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
Intervention Type
Drug
Intervention Name(s)
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 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.
Primary Outcome Measure Information:
Title
SNOT-22 Questionnaire
Description
The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms ("nasal obstruction" and "loss of smell and taste") ranked from 0 (not a problem) to 5 (problem as bad as it can be). Min score= 0, Max score= 110 ("worst possible problem" on all symptoms) 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.
Time Frame
4-6 weeks and 3 months after initiation of treatment
Secondary Outcome Measure Information:
Title
Lund-McKay Score From CT Scan
Description
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.
Time Frame
4-6 weeks and 3 months after initiation of treatment
Title
Taskforce Symptom Inventory
Description
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.
Time Frame
4-6 weeks and 3 months after initiation of treatment
Title
Medication Side-effect and Compliance Inventory
Description
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.
Time Frame
4-6 weeks and 3 months after initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the Taskforce on Rhinosinusitis. 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. They do not have nasal polyps on initial clinic nasal endoscopy They are willing to participate in a clinical study They are between the ages of 18 to 80. Exclusion Criteria: They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded. They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded. They have been treated with a > 3 week course of antibiotics and/or systemic steroids will also be excluded. They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis. They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants. They have nasal polyps on physical exam. They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging. They have a Lund-Mckay score on CT scan of < 6 They are < 18 or > 80 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Tan, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
: Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16815148
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.
Results Reference
background
PubMed Identifier
17903570
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.
Results Reference
background
PubMed Identifier
19793277
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.
Results Reference
background
PubMed Identifier
11486442
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.
Results Reference
background
PubMed Identifier
12862401
Citation
Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42.
Results Reference
background
PubMed Identifier
16467702
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.
Results Reference
background
Links:
URL
http://www.northwestern-sinus.com/
Description
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Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

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