Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Bruce Tan, Northwestern University
ClinicalTrials.gov Identifier:
NCT01676415
First received: August 24, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Chronic Rhinosinusitis Without Nasal Polyps
Drug: Prednisone
Drug: Topical mometasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Short Term Systemic Corticosteroid Therapy in the Management of Chronic Rhinosinusitis Without Nasal Polyps

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Lund-McKay score from CT scan [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Taskforce symptom inventory [ Time Frame: 4-6 weeks and 3 months after initiation of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prednisone
Oral steroid medication
Drug: Prednisone

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

Other Names:
  • Glucocorticoid
  • Deltasone
  • Liquid Pred
  • Meticorten
  • Orasone
  • Prednicen-M
  • Prednicot
  • Sterapred
  • Sterapred DS
Active Comparator: Topical Mometasone
Topical steroid medication
Drug: Topical mometasone

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.


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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676415

Contacts
Contact: Caroline Price 312-695-0513 caroline.price@northwestern.edu

Locations
United States, Illinois
: Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Caroline Price    312-695-0513    caroline.price@northwestern.edu   
Principal Investigator: Bruce Tan, MD         
Sub-Investigator: Robert Kern, MD         
Sub-Investigator: Jill Fredona, RN         
Sub-Investigator: David Conley, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Bruce Tan, MD Northwestern University
  More Information

Additional Information:
Publications:
Responsible Party: Bruce Tan, MD, Assistant Professor, Dept of Otolaryngology, Northwestern University Feinberg School of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01676415     History of Changes
Other Study ID Numbers: 18369
Study First Received: August 24, 2012
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Sinus disease
Sinonasal complaints
Chronic sinusitis
Nasal polyps
Chronic rhinosinusitis without nasal polyps
Glucocorticoids
Prednisone
Topical mometasone
Anti-inflammatory agents

Additional relevant MeSH terms:
Nasal Polyps
Polyps
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Respiratory Tract Infections
Mometasone furoate
Anti-Inflammatory Agents
Prednisone
Glucocorticoids
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 22, 2014