Sinusitis
Conditions
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.
Interventions
DRUG6 day Prednisone
6 day prednisone burst
DRUGAugmentin
Antibiotic augmentin for 3 weeks
DRUG21 day Prednisone
21 day prednisone burst
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Nasal Endoscopy | 4 weeks post treatment | Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antibiotic Only 1\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.
Augmentin: Antibiotic augmentin for 3 weeks | 7 |
| 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)
6 day Prednisone: 6 day prednisone burst
Augmentin: Antibiotic augmentin for 3 weeks | 6 |
| 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. )
Augmentin: Antibiotic augmentin for 3 weeks
21 day Prednisone: 21 day prednisone burst | 6 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Augmentin With 6 Day Steroid | Augmentin With 21 Day Steroid | Antibiotic Only |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 4 Participants | 5 Participants | 5 Participants |
| Age, Continuous | 50.8 years STANDARD_DEVIATION 1 | 58.5 years STANDARD_DEVIATION 1 | 41.2 years STANDARD_DEVIATION 1 | 53.28 years STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 5 Participants | 5 Participants | 6 Participants |
| Region of Enrollment United States | 19 Participants | 6 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 10 Participants | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: 4 week post treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antibiotic Only | CT Scan Changes | 10.33 score out of total 20 |
| Augmentin With 6 Day Steroid | CT Scan Changes | 11 score out of total 20 |
| Augmentin With 21 Day Steroid | CT Scan Changes | 11.83 score out of total 20 |
Primary
Nasal Endoscopy
Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better
Time frame: 4 weeks post treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antibiotic Only | Nasal Endoscopy | 2.55 score out of total 12 |
| Augmentin With 6 Day Steroid | Nasal Endoscopy | 3.00 score out of total 12 |
| Augmentin With 21 Day Steroid | Nasal Endoscopy | 2.16 score out of total 12 |
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
Time frame: 4 weeks post treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antibiotic Only | Sinonasal Outcome Test (SNOT 20) | 50.33 Score out of total 100 |
| Augmentin With 6 Day Steroid | Sinonasal Outcome Test (SNOT 20) | 53.14 Score out of total 100 |
| Augmentin With 21 Day Steroid | Sinonasal Outcome Test (SNOT 20) | 37 Score out of total 100 |