Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 12:36 AM
Study NCT ID:
NCT01913795
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061808', 'term': 'Air Filters'}], 'ancestors': [{'id': 'D005374', 'term': 'Filtration'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Wanda.Phipatanakul@childrens.harvard.edu', 'phone': '617-355-6117', 'title': 'Dr. Wanda Phipatanakul', 'organization': "Boston Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Air Purifier + IPM', 'description': 'classroom air purifiers and school integrated pest management environmental intervention\n\nintegrated pest management: integrated pest management and environmental strategy\n\nair purifier: air purifiers', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham and no IPM', 'description': 'sham air purifiers and no school integrated pest management environmental intervention', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Air Purifier and no IPM', 'description': 'air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sham and IPM', 'description': 'classroom sham air purifiers and school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Asthma Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Purifier + IPM', 'description': '4 subjects\n\nclassroom air purifiers and school integrated pest management environmental intervention\n\nintegrated pest management: integrated pest management and environmental strategy\n\nair purifier: air purifiers'}, {'id': 'OG001', 'title': 'Sham and no IPM', 'description': '7 subjects\n\nsham air purifiers and no school integrated pest management environmental intervention'}, {'id': 'OG002', 'title': 'Air Purifier and no IPM', 'description': '9 subjects\n\nair purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'OG003', 'title': 'Sham and IPM', 'description': '5 subjects\n\nclassroom sham air purifiers and school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.4', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'month 3', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '9'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '4'}]}]}, {'title': 'month 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '3.25', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'month 9', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '8.25', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '14'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'month 12', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over a two week period at Baseline and Months 3, 6, 9 and 12', 'description': 'number of days of wheezing/cough', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.'}, {'type': 'SECONDARY', 'title': 'Lung Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Purifier + IPM', 'description': '4 subjects\n\nclassroom air purifiers and school integrated pest management environmental intervention\n\nintegrated pest management: integrated pest management and environmental strategy\n\nair purifier: air purifiers'}, {'id': 'OG001', 'title': 'Sham and no IPM', 'description': '7 subjects\n\nsham air purifiers and no school integrated pest management environmental intervention'}, {'id': 'OG002', 'title': 'Air Purifier and no IPM', 'description': '9 subjects\n\nair purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'OG003', 'title': 'Sham and IPM', 'description': '5 subjects\n\nclassroom sham air purifiers and school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '0.3', 'groupId': 'OG003'}]}]}, {'title': 'month 6', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '0.3', 'groupId': 'OG003'}]}]}, {'title': 'month 12', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured at baseline and months 6 and 12', 'description': 'peak expiratory flow (PEF)', 'unitOfMeasure': 'Liters/second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Air Purifier + IPM', 'description': 'classroom air purifiers and school integrated pest management environmental intervention\n\nintegrated pest management: integrated pest management and environmental strategy\n\nair purifier: air purifiers'}, {'id': 'FG001', 'title': 'Sham and no IPM', 'description': 'sham air purifiers and no school integrated pest management environmental intervention'}, {'id': 'FG002', 'title': 'Air Purifier and no IPM', 'description': 'air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'FG003', 'title': 'Sham and IPM', 'description': 'classroom sham air purifiers and school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Air Purifier + IPM', 'description': 'classroom air purifiers and school integrated pest management environmental intervention\n\nintegrated pest management: integrated pest management and environmental strategy\n\nair purifier: air purifiers'}, {'id': 'BG001', 'title': 'Sham and no IPM', 'description': 'sham air purifiers and no school integrated pest management environmental intervention'}, {'id': 'BG002', 'title': 'Air Purifier and no IPM', 'description': 'air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'BG003', 'title': 'Sham and IPM', 'description': 'classroom sham air purifiers and school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '10.0', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '12'}, {'value': '9.2', 'groupId': 'BG002', 'lowerLimit': '7', 'upperLimit': '11'}, {'value': '9.4', 'groupId': 'BG003', 'lowerLimit': '8', 'upperLimit': '12'}, {'value': '9.4', 'groupId': 'BG004', 'lowerLimit': '7', 'upperLimit': '12'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Forced Vital Capacity (FVC)', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'BG000', 'lowerLimit': '1.2', 'upperLimit': '1.7'}, {'value': '1.6', 'groupId': 'BG001', 'lowerLimit': '.8', 'upperLimit': '2.5'}, {'value': '1.6', 'groupId': 'BG002', 'lowerLimit': '1.1', 'upperLimit': '2.3'}, {'value': '1.8', 'groupId': 'BG003', 'lowerLimit': '1.2', 'upperLimit': '2.4'}, {'value': '1.6', 'groupId': 'BG004', 'lowerLimit': '.8', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liters', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-05', 'studyFirstSubmitDate': '2013-05-21', 'resultsFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-15', 'studyFirstPostDateStruct': {'date': '2013-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma Symptoms', 'timeFrame': 'over a two week period at Baseline and Months 3, 6, 9 and 12', 'description': 'number of days of wheezing/cough'}], 'secondaryOutcomes': [{'measure': 'Lung Function', 'timeFrame': 'measured at baseline and months 6 and 12', 'description': 'peak expiratory flow (PEF)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The investigators aim to pilot the role of school based intervention consisting of enhanced integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.', 'detailedDescription': 'By piloting this school based intervention, the investigators hope to learn from this study the best way to design and implement more cost and time efficient large-based school-based environmental interventions that may potentially help a community of children with asthma, allergic diseases, and its associated morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* grades K-8 with asthma attending sampling/intervention schools\n\nExclusion Criteria:\n\n* moving schools'}, 'identificationModule': {'nctId': 'NCT01913795', 'briefTitle': 'Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma', 'orgStudyIdInfo': {'id': '266134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Environmental Intervention', 'description': '4 classroom air purifiers and school integrated pest management environmental intervention', 'interventionNames': ['Other: integrated pest management', 'Other: air purifier']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham and Control', 'description': '4 sham air purifiers and no school integrated pest management environmental intervention', 'interventionNames': ['Other: Sham air purifier']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Active Air Purifier and Control', 'description': '4 air purifiers and no school integrated pest management environmental intervention', 'interventionNames': ['Other: air purifier']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham and Integrated Pest Management', 'description': '4 classroom sham air purifiers and school integrated pest management', 'interventionNames': ['Other: integrated pest management']}], 'interventions': [{'name': 'integrated pest management', 'type': 'OTHER', 'description': 'integrated pest management and environmental strategy', 'armGroupLabels': ['Environmental Intervention', 'Sham and Integrated Pest Management']}, {'name': 'air purifier', 'type': 'OTHER', 'description': 'air purifiers', 'armGroupLabels': ['Active Air Purifier and Control', 'Environmental Intervention']}, {'name': 'Sham air purifier', 'type': 'OTHER', 'description': 'sham air purifiers', 'armGroupLabels': ['Sham and Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Wanda Phipatanakul', 'investigatorAffiliation': "Boston Children's Hospital"}}}}