Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927834
• Other study ID #: 5130196
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: January 2019

Study information

• Verified date: December 2020
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasal Polyps
• Sinusitis

Intervention

Drug:
• 6 day Prednisone
6 day prednisone burst
• Augmentin
Antibiotic augmentin for 3 weeks
• 21 day Prednisone
21 day prednisone burst

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks post treatment
Primary	Nasal Endoscopy	Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better	4 weeks post treatment
Primary	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.	4 week post treatment