Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-27 @ 1:28 AM
Study NCT ID:
NCT02927834
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kseiberling@llu.edu', 'phone': '9095582002', 'title': 'Dr. Kristin Seiberling', 'organization': 'Loma Linda University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Patients were seen back in the office for adverse event collection', 'eventGroups': [{'id': 'EG000', 'title': 'Antibiotic Only', 'description': '1\\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.\n\nAugmentin: Antibiotic augmentin for 3 weeks', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Augmentin With 6 Day Steroid', 'description': '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)\n\n6 day Prednisone: 6 day prednisone burst\n\nAugmentin: Antibiotic augmentin for 3 weeks', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Augmentin With 21 Day Steroid', 'description': '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. )\n\nAugmentin: Antibiotic augmentin for 3 weeks\n\n21 day Prednisone: 21 day prednisone burst', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sinonasal Outcome Test (SNOT 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotic Only', 'description': '1\\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'OG001', 'title': 'Augmentin With 6 Day Steroid', 'description': '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)\n\n6 day Prednisone: 6 day prednisone burst\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'OG002', 'title': 'Augmentin With 21 Day Steroid', 'description': '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. )\n\nAugmentin: Antibiotic augmentin for 3 weeks\n\n21 day Prednisone: 21 day prednisone burst'}], 'classes': [{'categories': [{'measurements': [{'value': '50.33', 'groupId': 'OG000', 'lowerLimit': '-2.21', 'upperLimit': '56.29'}, {'value': '53.14', 'groupId': 'OG001', 'lowerLimit': '1.79', 'upperLimit': '59.92'}, {'value': '37', 'groupId': 'OG002', 'lowerLimit': '2.85', 'upperLimit': '39'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks post treatment', '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', 'unitOfMeasure': 'Score out of total 100', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Nasal Endoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotic Only', 'description': '1\\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'OG001', 'title': 'Augmentin With 6 Day Steroid', 'description': '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)\n\n6 day Prednisone: 6 day prednisone burst\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'OG002', 'title': 'Augmentin With 21 Day Steroid', 'description': '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. )\n\nAugmentin: Antibiotic augmentin for 3 weeks\n\n21 day Prednisone: 21 day prednisone burst'}], 'classes': [{'categories': [{'measurements': [{'value': '2.55', 'groupId': 'OG000', 'lowerLimit': '-2.197', 'upperLimit': '2.974'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '1.793', 'upperLimit': '3.492'}, {'value': '2.16', 'groupId': 'OG002', 'lowerLimit': '-2.37', 'upperLimit': '3.37'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks post treatment', 'description': 'Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better', 'unitOfMeasure': 'score out of total 12', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'CT Scan Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotic Only', 'description': '1\\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'OG001', 'title': 'Augmentin With 6 Day Steroid', 'description': '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)\n\n6 day Prednisone: 6 day prednisone burst\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'OG002', 'title': 'Augmentin With 21 Day Steroid', 'description': '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. )\n\nAugmentin: Antibiotic augmentin for 3 weeks\n\n21 day Prednisone: 21 day prednisone burst'}], 'classes': [{'categories': [{'measurements': [{'value': '10.33', 'groupId': 'OG000', 'lowerLimit': '8.15', 'upperLimit': '11.3'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '7.68', 'upperLimit': '11.8'}, {'value': '11.83', 'groupId': 'OG002', 'lowerLimit': '5.13', 'upperLimit': '13.15'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 week post treatment', '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.', 'unitOfMeasure': 'score out of total 20', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Antibiotic Only', 'description': '1\\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'FG001', 'title': 'Augmentin With 6 Day Steroid', 'description': '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)\n\n6 day Prednisone: 6 day prednisone burst\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'FG002', 'title': 'Augmentin With 21 Day Steroid', 'description': '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. )\n\nAugmentin: Antibiotic augmentin for 3 weeks\n\n21 day Prednisone: 21 day prednisone burst'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Antibiotic Only', 'description': '1\\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'BG001', 'title': 'Augmentin With 6 Day Steroid', 'description': '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)\n\n6 day Prednisone: 6 day prednisone burst\n\nAugmentin: Antibiotic augmentin for 3 weeks'}, {'id': 'BG002', 'title': 'Augmentin With 21 Day Steroid', 'description': '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. )\n\nAugmentin: Antibiotic augmentin for 3 weeks\n\n21 day Prednisone: 21 day prednisone burst'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.28', 'spread': '1', 'groupId': 'BG000'}, {'value': '58.5', 'spread': '1', 'groupId': 'BG001'}, {'value': '41.2', 'spread': '1', 'groupId': 'BG002'}, {'value': '50.8', 'spread': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2020-12-03', 'size': 410886, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-03T15:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2016-08-04', 'resultsFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2016-10-06', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-03', 'studyFirstPostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sinonasal Outcome Test (SNOT 20)', 'timeFrame': '4 weeks post treatment', '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'}, {'measure': 'Nasal Endoscopy', 'timeFrame': '4 weeks post treatment', 'description': 'Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better'}, {'measure': 'CT Scan Changes', 'timeFrame': '4 week post treatment', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sinusitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the taskforce on rhinosinusitis.\n2. 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.\n3. They do not have nasal polyps on initial clinic nasal endoscopy\n4. They are willing to participate in a clinical study\n5. They are between the ages of 18 to 80.\n\nExclusion Criteria:\n\n1. They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded.\n2. They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded.\n3. They have been treated with a \\> 3 week course of antibiotics and/or systemic steroids will also be excluded.\n4. They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.\n5. They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants.\n6. They have nasal polyps on physical exam.\n7. They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging.\n8. They have a Lund-Mackay score on CT scan of \\< 6\n9. They are \\< 18 or \\> 80 years old"}, 'identificationModule': {'nctId': 'NCT02927834', 'briefTitle': 'Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'The Role of Oral Steroids in the Management of Chronic Rhinosinusitis Without Nasal Polyps', 'orgStudyIdInfo': {'id': '5130196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotic only', 'description': '1\\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.', 'interventionNames': ['Drug: Augmentin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Augmentin with 6 day steroid', 'description': '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)', 'interventionNames': ['Drug: 6 day Prednisone', 'Drug: Augmentin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Augmentin with 21 day steroid', 'description': '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. )', 'interventionNames': ['Drug: Augmentin', 'Drug: 21 day Prednisone']}], 'interventions': [{'name': '6 day Prednisone', 'type': 'DRUG', 'description': '6 day prednisone burst', 'armGroupLabels': ['Augmentin with 6 day steroid']}, {'name': 'Augmentin', 'type': 'DRUG', 'description': 'Antibiotic augmentin for 3 weeks', 'armGroupLabels': ['Antibiotic only', 'Augmentin with 21 day steroid', 'Augmentin with 6 day steroid']}, {'name': '21 day Prednisone', 'type': 'DRUG', 'description': '21 day prednisone burst', 'armGroupLabels': ['Augmentin with 21 day steroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kristin Seiberling, MD', 'investigatorAffiliation': 'Loma Linda University'}}}}