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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic only | Active Comparator | 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. |
|
| 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) |
|
| 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. ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6 day Prednisone | Drug | 6 day prednisone burst |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotic Only | 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin for 3 weeks |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Antibiotic Only | 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin for 3 weeks |
| BG001 | Augmentin With 6 Day Steroid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | 95% Confidence Interval | Score out of total 100 | 4 weeks post treatment |
|
12 weeks
Patients were seen back in the office for adverse event collection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antibiotic Only | 1. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks. Augmentin: Antibiotic augmentin for 3 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristin Seiberling | Loma Linda University | 9095582002 | kseiberling@llu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2020 | Dec 3, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Augmentin |
| Drug |
Antibiotic augmentin for 3 weeks |
|
| 21 day Prednisone | Drug | 21 day prednisone burst |
|
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
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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 |
|
|
| Primary | Nasal Endoscopy | Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better | Posted | Mean | 95% Confidence Interval | score out of total 12 | 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. | Posted | Mean | 95% Confidence Interval | score out of total 20 | 4 week post treatment |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |