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Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

Primary Purpose

Sinusitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

6 day Prednisone

Augmentin

21 day Prednisone

About this trial

This is an interventional treatment trial for Sinusitis

Eligibility Criteria

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

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 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.
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-Mackay score on CT scan of < 6
They are < 18 or > 80 years old

Sites / Locations

Loma Linda University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Antibiotic only

Augmentin with 6 day steroid

Augmentin with 21 day steroid

Arm Description

1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.

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)

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. )

Outcomes

Primary Outcome Measures

Sinonasal Outcome Test (SNOT 20)

Sinonasal outcome test to access nasal/sinus symptoms. 20 questions, each question scored 0-5. 0 meaning no symptoms, 5 worse. 0- 100 total with lower number meaning better outcome

Nasal Endoscopy

Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better

CT Scan Changes

CT scan of the sinuses, Lund Mackay score to access severity of sinus disease on CT scan. Scored on scale 0-20 with lower score better.

Secondary Outcome Measures

Full Information

NCT ID

NCT02927834

First Posted

August 4, 2016

Last Updated

December 3, 2020

Sponsor

Loma Linda University

1. Study Identification

Unique Protocol Identification Number

NCT02927834

Brief Title

Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

Official Title

The Role of Oral Steroids in the Management of Chronic Rhinosinusitis Without Nasal Polyps

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loma Linda University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Sinusitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Antibiotic only

Arm Type

Active Comparator

Arm Description

1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.

Arm Title

Augmentin with 6 day steroid

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Augmentin with 21 day steroid

Arm Type

Active Comparator

Arm Description

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. )

Intervention Type

Drug

Intervention Name(s)

6 day Prednisone

Intervention Description

6 day prednisone burst

Intervention Type

Drug

Intervention Name(s)

Augmentin

Intervention Description

Antibiotic augmentin for 3 weeks

Intervention Type

Drug

Intervention Name(s)

21 day Prednisone

Intervention Description

21 day prednisone burst

Primary Outcome Measure Information:

Title

Sinonasal Outcome Test (SNOT 20)

Description

Sinonasal outcome test to access nasal/sinus symptoms. 20 questions, each question scored 0-5. 0 meaning no symptoms, 5 worse. 0- 100 total with lower number meaning better outcome

Time Frame

4 weeks post treatment

Title

Nasal Endoscopy

Description

Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better

Time Frame

4 weeks post treatment

Title

CT Scan Changes

Description

CT scan of the sinuses, Lund Mackay score to access severity of sinus disease on CT scan. Scored on scale 0-20 with lower score better.

Time Frame

4 week post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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 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. 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-Mackay score on CT scan of < 6 They are < 18 or > 80 years old

Facility Information:

Facility Name

Loma Linda University Medical Center

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

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