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Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

This study is currently recruiting participants.
Verified September 2017 by Kristin Seiberling, MD, Loma Linda University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02927834
First Posted: October 7, 2016
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristin Seiberling, MD, Loma Linda University
  Purpose
Chronic rhinosinusitis is a common disease that effects millions of people world wide. Despite its frequency it is unclear what treatment options are the best for these patients. Typically patients with chronic rhinosinusitis without nasal polyps (CRSsNP) are given a long term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and occasionally oral steroids. Oral steroids benefit patients with chronic rhinosinusitis with nasal polyps (CRSwNP) however their role in non polyp patients is less clear. It is the goal of this study to see if oral steroids benefit the treatment outcomes in those patients with chronic rhinosinusitis without nasal polyps. In addition this study will look to see if a short course (5 day burst) versus a longer course (21 day taper) of oral steroids make a difference in outcomes.

Condition Intervention
Sinusitis Drug: 6 day Prednisone Drug: Augmentin Drug: 21 day Prednisone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Oral Steroids in the Management of Chronic Rhinosinusitis Without Nasal Polyps

Resource links provided by NLM:


Further study details as provided by Kristin Seiberling, MD, Loma Linda University:

Primary Outcome Measures:
  • Sinonasal outcome test (SNOT 20) [ Time Frame: 4 weeks post treatment ]
    Sinonasal outcome test to access nasal/sinus symptoms

  • Nasal endoscopy [ Time Frame: 4 weeks post treatment ]
    Physical exam findings of the nasal cavity

  • CT scan changes [ Time Frame: 4 week post treatment ]
    CT scan of the sinuses, Lund Mackay score to access severity of sinus disease on CT scan


Estimated Enrollment: 40
Study Start Date: August 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antibiotic only
1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.
Drug: Augmentin
Antibiotic augmentin for 3 weeks
Active Comparator: Augmentin with 6 day steroid
Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)
Drug: 6 day Prednisone
6 day prednisone burst
Drug: Augmentin
Antibiotic augmentin for 3 weeks
Active Comparator: Augmentin with 21 day steroid
Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )
Drug: Augmentin
Antibiotic augmentin for 3 weeks
Drug: 21 day Prednisone
21 day prednisone burst

Detailed Description:
The investigators will compare patients with CRSsNP who are treated with antibiotics/nasal steroid sprays, and compare them to chronic sinusitis patients who receive antibiotics/nasal steroid spray along with a course of oral steroids. The goal is to determine if oral steroids have a role in CRSsNP, and if so, the most effective dosage.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 the clinic or have a viewable recent (< 3 weeks prior to clinic visit) CT-scan with a Lund Mackay score of 6 or greater. A Lund Mackay 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-Mackay score on CT scan of < 6
  9. They are < 18 or > 80 years old
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927834


Locations
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Kristin Seiberling, MD    909-558-2002    kseiberling@llu.edu   
Principal Investigator: Kristin A Seiberling, MD         
Sponsors and Collaborators
Loma Linda University
  More Information

Responsible Party: Kristin Seiberling, MD, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT02927834     History of Changes
Other Study ID Numbers: 5130196
First Submitted: August 4, 2016
First Posted: October 7, 2016
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Prednisone
Amoxicillin-Potassium Clavulanate Combination
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents