Clincosm LogoSign in Get a demo

Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT02927834
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
41
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Role of Oral Steroids in the Management of Chronic Rhinosinusitis Without Nasal Polyps
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Antibiotic only

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

Drug: Augmentin
Antibiotic augmentin for 3 weeks
Active Comparator: 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)

Drug: 6 day Prednisone
6 day prednisone burst

Drug: Augmentin
Antibiotic augmentin for 3 weeks
Active Comparator: 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. )

Drug: Augmentin
Antibiotic augmentin for 3 weeks

Drug: 21 day Prednisone
21 day prednisone burst

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Nasal Endoscopy [4 weeks post treatment]

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

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University Medical Center Loma Linda California United States 92354

Sponsors and Collaborators

  • Loma Linda University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Kristin Seiberling, MD, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier:
NCT02927834
Other Study ID Numbers:
  • 5130196
First Posted:
Oct 7, 2016
Last Update Posted:
Dec 29, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Amoxicillin-Potassium Clavulanate Combination
Prednisone

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Antibiotic Only Augmentin With 6 Day Steroid Augmentin With 21 Day Steroid
Arm/Group Description 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin 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) 6 day Prednisone: 6 day prednisone burst Augmentin: Antibiotic augmentin for 3 weeks 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. ) Augmentin: Antibiotic augmentin for 3 weeks 21 day Prednisone: 21 day prednisone burst
Period Title: Overall Study
STARTED 8 8 8
COMPLETED 7 6 6
NOT COMPLETED 1 2 2

Baseline Characteristics

Arm/Group Title Antibiotic Only Augmentin With 6 Day Steroid Augmentin With 21 Day Steroid Total
Arm/Group Description 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin 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) 6 day Prednisone: 6 day prednisone burst Augmentin: Antibiotic augmentin for 3 weeks 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. ) Augmentin: Antibiotic augmentin for 3 weeks 21 day Prednisone: 21 day prednisone burst Total of all reporting groups
Overall Participants 7 6 6 19
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
5
71.4%
4
66.7%
5
83.3%
14
73.7%
>=65 years
2
28.6%
2
33.3%
1
16.7%
5
26.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
53.28
(1)
58.5
(1)
41.2
(1)
50.8
(1)
Sex: Female, Male (Count of Participants)
Female
2
28.6%
5
83.3%
2
33.3%
9
47.4%
Male
5
71.4%
1
16.7%
4
66.7%
10
52.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
0
0%
White
6
85.7%
5
83.3%
5
83.3%
16
84.2%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
1
14.3%
1
16.7%
1
16.7%
3
15.8%
Region of Enrollment (Count of Participants)
United States
7
100%
6
100%
6
100%
19
100%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Antibiotic Only Augmentin With 6 Day Steroid Augmentin With 21 Day Steroid
Arm/Group Description 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin 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) 6 day Prednisone: 6 day prednisone burst Augmentin: Antibiotic augmentin for 3 weeks 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. ) Augmentin: Antibiotic augmentin for 3 weeks 21 day Prednisone: 21 day prednisone burst
Measure Participants 7 6 6
Mean (95% Confidence Interval) [Score out of total 100]
50.33
53.14
37
2. Primary Outcome
Title Nasal Endoscopy
Description Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better
Time Frame 4 weeks post treatment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Antibiotic Only Augmentin With 6 Day Steroid Augmentin With 21 Day Steroid
Arm/Group Description 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin 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) 6 day Prednisone: 6 day prednisone burst Augmentin: Antibiotic augmentin for 3 weeks 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. ) Augmentin: Antibiotic augmentin for 3 weeks 21 day Prednisone: 21 day prednisone burst
Measure Participants 7 6 6
Mean (95% Confidence Interval) [score out of total 12]
2.55
3.00
2.16
3. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Antibiotic Only Augmentin With 6 Day Steroid Augmentin With 21 Day Steroid
Arm/Group Description 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin 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) 6 day Prednisone: 6 day prednisone burst Augmentin: Antibiotic augmentin for 3 weeks 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. ) Augmentin: Antibiotic augmentin for 3 weeks 21 day Prednisone: 21 day prednisone burst
Measure Participants 7 6 6
Mean (95% Confidence Interval) [score out of total 20]
10.33
11
11.83

Adverse Events

Time Frame 12 weeks
Adverse Event Reporting Description Patients were seen back in the office for adverse event collection
Arm/Group Title Antibiotic Only Augmentin With 6 Day Steroid Augmentin With 21 Day Steroid
Arm/Group Description 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin 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) 6 day Prednisone: 6 day prednisone burst Augmentin: Antibiotic augmentin for 3 weeks 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. ) Augmentin: Antibiotic augmentin for 3 weeks 21 day Prednisone: 21 day prednisone burst
All Cause Mortality
Antibiotic Only Augmentin With 6 Day Steroid Augmentin With 21 Day Steroid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/7 (0%) 0/6 (0%) 0/6 (0%)
Serious Adverse Events
Antibiotic Only Augmentin With 6 Day Steroid Augmentin With 21 Day Steroid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/7 (0%) 0/6 (0%) 0/6 (0%)
Other (Not Including Serious) Adverse Events
Antibiotic Only Augmentin With 6 Day Steroid Augmentin With 21 Day Steroid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/7 (0%) 0/6 (0%) 0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Kristin Seiberling
Organization Loma Linda University
Phone 9095582002
Email kseiberling@llu.edu
Responsible Party:
Kristin Seiberling, MD, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier:
NCT02927834
Other Study ID Numbers:
  • 5130196
First Posted:
Oct 7, 2016
Last Update Posted:
Dec 29, 2020
Last Verified:
Dec 1, 2020