Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-01 @ 4:56 AM
Study NCT ID:
NCT00924404
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2009-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Xylitol Versus Saline in Chronic Sinusitis
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': 'D014993', 'term': 'Xylitol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lakshmi-durairaj@uiowa.edu', 'phone': '319-353-7968', 'title': 'Lakshmi Durairaj', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Xylitol', 'description': 'isotonic xylitol for sinus rinse\n\nXylitol: 5% solution for sinus rinse', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline', 'description': 'saline for sinus rinse\n\nSaline: saline for sinus rinse', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SNOT-20 Scores at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xylitol', 'description': 'isotonic xylitol for sinus rinse\n\nXylitol: 5% solution for sinus rinse'}, {'id': 'OG001', 'title': 'Saline', 'description': 'saline for sinus rinse\n\nSaline: saline for sinus rinse'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '15', 'groupId': 'OG000'}, {'value': '11', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Sinonasal outcome test is a 20 item quality of life questionnaire: Min-Max score range 0-100 The SNOT score for each patient was defined as the mean value of the response to the 20 items. The questionnaire is divided into 4 subsets, symptoms related to nose, symptoms of ear and face, sleep quality and psychological issues.\n\nSymptoms arereported on 100 mm visual analog scales (VASs) where 0 mm represents no symptoms and 100 mm represent "as troublesome as possible". The symptom severity is considered mild between 0 and 30, moderate from 30 to 70 and severe from 70- 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We initially enrolled 53 subjects but we had 10 subjects drop out of the study.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Antibiotic Courses During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xylitol', 'description': 'isotonic xylitol for sinus rinse\n\nXylitol: 5% solution for sinus rinse'}, {'id': 'OG001', 'title': 'Saline', 'description': 'saline for sinus rinse\n\nSaline: saline for sinus rinse'}], 'classes': [{'categories': [{'measurements': [{'value': '1.90', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean Number of antibiotic courses for infection during the study period', 'unitOfMeasure': 'mean number of antibiotic courses during', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xylitol', 'description': 'isotonic xylitol for sinus rinse\n\nXylitol: 5% solution for sinus rinse'}, {'id': 'FG001', 'title': 'Saline', 'description': 'saline for sinus rinse\n\nSaline: saline for sinus rinse'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Xylitol', 'description': 'isotonic xylitol for sinus rinse\n\nXylitol: 5% solution for sinus rinse'}, {'id': 'BG001', 'title': 'Saline', 'description': 'saline for sinus rinse\n\nSaline: saline for sinus rinse'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '14', 'groupId': 'BG000'}, {'value': '55', 'spread': '17', 'groupId': 'BG001'}, {'value': '54', 'spread': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2009-06-18', 'resultsFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-10', 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SNOT-20 Scores at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'Sinonasal outcome test is a 20 item quality of life questionnaire: Min-Max score range 0-100 The SNOT score for each patient was defined as the mean value of the response to the 20 items. The questionnaire is divided into 4 subsets, symptoms related to nose, symptoms of ear and face, sleep quality and psychological issues.\n\nSymptoms arereported on 100 mm visual analog scales (VASs) where 0 mm represents no symptoms and 100 mm represent "as troublesome as possible". The symptom severity is considered mild between 0 and 30, moderate from 30 to 70 and severe from 70- 100.'}], 'secondaryOutcomes': [{'measure': 'Mean Number of Antibiotic Courses During the Study Period', 'timeFrame': '12 weeks', 'description': 'Mean Number of antibiotic courses for infection during the study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Xylitol vs. Saline', 'nasal washes', 'sinusitis'], 'conditions': ['Chronic Sinusitis']}, 'descriptionModule': {'briefSummary': 'Is a xylitol nasal rinse better or worse than saline on patient satisfaction.', 'detailedDescription': 'In this pilot study, the investigators plan to compare the efficacy of twice daily xylitol nasal rinse with saline rinse which is the current standard, on outcomes such as quality of life and exacerbations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'We now have two arms to this study.\n\nGroup I: Immunocompetent subjects with chronic rhinosinusitis\n\nInclusion Criteria:\n\n* 56 Adult subjects (18 or older) presenting to the ENT(ears, nose, throat) clinics who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:\n\n * Anterior and/or posterior mucopurulent drainage\n * Nasal obstruction\n * Facial pain, pressure, and/or fullness\n * Decreased sense of smell\n* In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.\n\nExclusion Criteria:\n\n* Cystic fibrosis\n* Fungal sinusitis\n* Immunocompromised status (use of long term oral steroids (\\> 30 days), AIDS, active malignancy or chemotherapy)\n* Known Ciliary disorders\n* Sinonasal tumors\n* Pregnancy\n\nGroup 2: CRS with antibody deficiency\n\n* 56 Adult subjects (18 or older) presenting to the Allergy clinic who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:\n\n * Anterior and/or posterior mucopurulent drainage\n * Nasal obstruction\n * Facial pain, pressure, and/or fullness\n * Decreased sense of smell\n* In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.\n\nExclusion criteria:\n\nCystic Fibrosis Sinonasal tumors Pregnancy'}, 'identificationModule': {'nctId': 'NCT00924404', 'briefTitle': 'Xylitol Versus Saline in Chronic Sinusitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis', 'orgStudyIdInfo': {'id': '200903757'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xylitol', 'description': 'isotonic xylitol for sinus rinse', 'interventionNames': ['Drug: Xylitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline', 'description': 'saline for sinus rinse', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Xylitol', 'type': 'DRUG', 'description': '5% solution for sinus rinse', 'armGroupLabels': ['Xylitol']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Salt solution'], 'description': 'saline for sinus rinse', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Lakshmi Durairaj, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lakshmi Durairaj', 'investigatorAffiliation': 'University of Iowa'}}}}