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Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

NCT ID: NCT02927834

Last Updated: 2020-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibiotic only

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

Group Type ACTIVE_COMPARATOR

Augmentin

Intervention Type DRUG

Antibiotic augmentin for 3 weeks

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)

Group Type ACTIVE_COMPARATOR

6 day Prednisone

Intervention Type DRUG

6 day prednisone burst

Augmentin

Intervention Type DRUG

Antibiotic augmentin for 3 weeks

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. )

Group Type ACTIVE_COMPARATOR

Augmentin

Intervention Type DRUG

Antibiotic augmentin for 3 weeks

21 day Prednisone

Intervention Type DRUG

21 day prednisone burst

Interventions

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6 day Prednisone

6 day prednisone burst

Intervention Type DRUG

Augmentin

Antibiotic augmentin for 3 weeks

Intervention Type DRUG

21 day Prednisone

21 day prednisone burst

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Kristin Seiberling, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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5130196

Identifier Type: -

Identifier Source: org_study_id