Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

NCT02927834 | Completed Results

• 1 other identifier: 5130196
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (3)

• 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

• Nasal Endoscopy

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

  4 weeks post treatment

• 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

Study Arms (3)

Antibiotic only

ACTIVE COMPARATOR

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

Drug: Augmentin

Augmentin with 6 day steroid

ACTIVE COMPARATOR

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; Drug: Augmentin

Augmentin with 21 day steroid

ACTIVE COMPARATOR

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; Drug: 21 day Prednisone

Interventions

6 day Prednisone DRUG

6 day prednisone burst

Augmentin with 6 day steroid

Augmentin DRUG

Antibiotic augmentin for 3 weeks

Antibiotic only; Augmentin with 21 day steroid; Augmentin with 6 day steroid

21 day Prednisone DRUG

21 day prednisone burst

Augmentin with 21 day steroid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Prednisone; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Kristin Seiberling
• Organization: Loma Linda University

kseiberling@llu.edu

9095582002

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: October 7, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: December 29, 2020
• Results First Posted: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)