Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Drug: 6 day Prednisone; Drug: Augmentin; Drug: 21 day Prednisone

• Registration Number: NCT02927834
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-07
• Primary Completion: 2018-12
• Study Completion: 2019-01
• Results First Submitted: 2020-10-09
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-03
• Last Update Submitted: 2020-12-03
• Results First Posted: 2020-12-29
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Augmentin with 6 day steroid	6 day Prednisone	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 day steroid	21 day Prednisone	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. )
Antibiotic only	Augmentin	1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.
Augmentin with 6 day steroid	Augmentin	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 day steroid	Augmentin	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. )

Primary Outcome Measures

Name	Time	Method
CT Scan Changes	4 week post treatment	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.
Nasal Endoscopy	4 weeks post treatment	Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better
Sinonasal Outcome Test (SNOT 20)	4 weeks post treatment	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

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States