Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 7:04 AM
Study NCT ID:
NCT01103934
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2010-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D Plus Fluticasone Propionate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rnacleri@surgery.bsd.uchicago.edu', 'phone': '(773) 702-0080', 'title': 'Robert M Naclerio, MD', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Fluticasone Propionate Plus Vitamin D3', 'description': 'Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season\n\nVitamin D3: 4000 IU once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fluticasone Propionate Plus Placebo', 'description': 'Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season\n\nPlacebo: Placebo taken once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Propionate Plus Vitamin D3', 'description': 'Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season\n\nVitamin D3: 4000 IU once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal'}, {'id': 'OG001', 'title': 'Fluticasone Propionate Plus Placebo', 'description': 'Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season\n\nPlacebo: Placebo taken once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.3', 'groupId': 'OG000', 'lowerLimit': '-18.9', 'upperLimit': '8.8'}, {'value': '-7.6', 'groupId': 'OG001', 'lowerLimit': '-18.7', 'upperLimit': '0.7'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Propionate Plus Vitamin D3', 'description': 'Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season\n\nVitamin D3: 4000 IU once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal'}, {'id': 'OG001', 'title': 'Fluticasone Propionate Plus Placebo', 'description': 'Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season\n\nPlacebo: Placebo taken once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.9', 'groupId': 'OG000', 'lowerLimit': '-10.2', 'upperLimit': '5.2'}, {'value': '-3.7', 'groupId': 'OG001', 'lowerLimit': '-10.6', 'upperLimit': '-0.2'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluticasone Propionate Plus Vitamin D3', 'description': 'Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season\n\nVitamin D3: 4000 IU once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal'}, {'id': 'FG001', 'title': 'Fluticasone Propionate Plus Placebo', 'description': 'Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season\n\nPlacebo: Placebo taken once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluticasone Propionate Plus Vitamin D3', 'description': 'Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season\n\nVitamin D3: 4000 IU once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal'}, {'id': 'BG001', 'title': 'Fluticasone Propionate Plus Placebo', 'description': 'Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season\n\nPlacebo: Placebo taken once daily\n\nFluticasone Propionate: 200 mcg daily, intranasal'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-06', 'studyFirstSubmitDate': '2010-04-13', 'resultsFirstSubmitDate': '2014-10-06', 'studyFirstSubmitQcDate': '2010-04-14', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-06', 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Seasonal Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Males and females between 18 and 45 years of age.\n2. History of tree, grass and/or ragweed allergic rhinitis.\n3. Positive skin test to tree, grass and/or ragweed antigen.\n4. Positive response to screening nasal challenge.\n\nExclusion Criteria\n\n1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.\n2. Pregnant or lactating women.\n3. Upper respiratory infection within 14 days of study start.'}, 'identificationModule': {'nctId': 'NCT01103934', 'briefTitle': 'Vitamin D Plus Fluticasone Propionate', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis', 'orgStudyIdInfo': {'id': '10-184-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fluticasone Propionate plus Vitamin D3', 'description': 'Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season', 'interventionNames': ['Drug: Vitamin D3', 'Drug: Fluticasone Propionate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Fluticasone Propionate plus Placebo', 'description': 'Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season', 'interventionNames': ['Drug: Placebo', 'Drug: Fluticasone Propionate']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DRUG', 'description': '4000 IU once daily', 'armGroupLabels': ['Fluticasone Propionate plus Vitamin D3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo taken once daily', 'armGroupLabels': ['Fluticasone Propionate plus Placebo']}, {'name': 'Fluticasone Propionate', 'type': 'DRUG', 'otherNames': ['Flonase'], 'description': '200 mcg daily, intranasal', 'armGroupLabels': ['Fluticasone Propionate plus Placebo', 'Fluticasone Propionate plus Vitamin D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Robert M Naclerio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}