Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT02291302
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2014-11-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
School Inner-City Asthma Intervention Study (SICAS-2)
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': 'Wanda Phipatanakul, MD. MS.', 'organization': "Boston Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'until study completion an average of 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Environmental Intervention', 'description': 'Active 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': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham and Control (Control)', 'description': 'Sham air purifiers and no school integrated pest management environmental intervention\n\nNo intervention (control): no integrated pest management and sham air purifier', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Active Air Purifier and Control', 'description': 'Active air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sham and Inegrated Pest', 'description': 'Sham air purifiers and active school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Number of Days With Asthma Symptoms Within 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Environmental Intervention', 'description': 'Active 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': 'OG001', 'title': 'Sham and Control (Control)', 'description': 'Sham air purifiers and no school integrated pest management environmental intervention\n\nNo intervention (control): no integrated pest management and sham air purifier'}, {'id': 'OG002', 'title': 'Active Air Purifier and Control', 'description': 'Active air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'OG003', 'title': 'Sham and Inegrated Pest', 'description': 'Sham air purifiers and active school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '2', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '3.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 12 months', 'description': 'Maximum number of\n\n1. Days with wheezing, tightness in the chest, or cough and/or\n2. Nights with disturbed sleep as a result of asthma and/or\n3. Days on which the child had to slow down or discontinue play activities because of asthma This is defined as a cumulative assessment from the different variables listed in the Measure Description', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lung Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Environmental Intervention', 'description': 'Active 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': 'OG001', 'title': 'Sham and Control (Control)', 'description': 'Sham air purifiers and no school integrated pest management environmental intervention\n\nNo intervention (control): no integrated pest management and sham air purifier'}, {'id': 'OG002', 'title': 'Active Air Purifier and Control', 'description': 'Active air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'OG003', 'title': 'Sham and Inegrated Pest', 'description': 'Sham air purifiers and active school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '99.2', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '97', 'spread': '14.1', 'groupId': 'OG002'}, {'value': '94.9', 'spread': '16.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Spirometry measure of forced expiration volume in 1 second', 'unitOfMeasure': 'percentage of predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'School Absences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Environmental Intervention', 'description': 'Active 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': 'OG001', 'title': 'Sham and Control (Control)', 'description': 'Sham air purifiers and no school integrated pest management environmental intervention\n\nNo intervention (control): no integrated pest management and sham air purifier'}, {'id': 'OG002', 'title': 'Active Air Purifier and Control', 'description': 'Active air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'OG003', 'title': 'Sham and Inegrated Pest', 'description': 'Sham air purifiers and active school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.75', 'groupId': 'OG001'}, {'value': '0.16', 'spread': '0.74', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.33', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Number of school days missed because of asthma/ 2 weeks', 'unitOfMeasure': 'days/2 weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Composite Asthma Severity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Environmental Intervention', 'description': 'Active 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': 'OG001', 'title': 'Sham and Control (Control)', 'description': 'Sham air purifiers and no school integrated pest management environmental intervention\n\nNo intervention (control): no integrated pest management and sham air purifier'}, {'id': 'OG002', 'title': 'Active Air Purifier and Control', 'description': 'Active air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'OG003', 'title': 'Sham and Inegrated Pest', 'description': 'Sham air purifiers and active school integrated pest management\n\nintegrated pest management: integrated pest management and environmental strategy'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '2.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': "\\[a comprehensive severity scale of day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations\\], health care utilization, and pulmonary function testing (PFT's) including FEV1; FEV1/FVC, FEF25-75. CASI ranges from 0 (lowest) -20 points (highest) with a minimal clinically important difference of 0.49 points. The higher score is worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Classroom Viral Exposure', 'timeFrame': '1 year', 'description': 'Classroom viral exposure will be assessed using two approaches:\n\n1. Airborne respiratory viral exposure (copies/m3)\n2. School viral exposure (assessed with virome sequencing)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'POST_HOC', 'title': 'Classroom Microbiome', 'timeFrame': '1 year', 'description': 'The classroom microbiome will be assessed with deep metagenomics sequencing', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Environmental Intervention', 'description': 'Active 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 Control (Control)', 'description': 'Sham air purifiers and no school integrated pest management environmental intervention\n\nNo intervention (control): no integrated pest management and sham air purifier'}, {'id': 'FG002', 'title': 'Active Air Purifier and Control', 'description': 'Active air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'FG003', 'title': 'Sham and Inegrated Pest', 'description': 'Sham air purifiers and active 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': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '236', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Environmental Intervention', 'description': 'Active 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 Control (Control)', 'description': 'Sham air purifiers and no school integrated pest management environmental intervention\n\nNo intervention (control): no integrated pest management and sham air purifier'}, {'id': 'BG002', 'title': 'Active Air Purifier and Control', 'description': 'Active air purifiers and no school integrated pest management environmental intervention\n\nair purifier: air purifiers'}, {'id': 'BG003', 'title': 'Sham and Inegrated Pest', 'description': 'Sham air purifiers and active 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, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '7.9', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '8.3', 'spread': '2.2', 'groupId': 'BG002'}, {'value': '8.2', 'spread': '2.0', 'groupId': 'BG003'}, {'value': '8.1', 'spread': '2.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '138', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '236', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maximum Number of Days With Asthma Symptoms Within 2 Weeks', 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '3.0', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '1.5', 'spread': '3.4', 'groupId': 'BG002'}, {'value': '2.4', 'spread': '4.2', 'groupId': 'BG003'}, {'value': '2.2', 'spread': '3.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-27', 'size': 2333634, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-01T12:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2014-11-07', 'resultsFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-21', 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lung Function', 'timeFrame': '12 months', 'description': 'Spirometry measure of forced expiration volume in 1 second'}, {'measure': 'School Absences', 'timeFrame': '12 months', 'description': 'Number of school days missed because of asthma/ 2 weeks'}, {'measure': 'Composite Asthma Severity Index', 'timeFrame': '12 months', 'description': "\\[a comprehensive severity scale of day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations\\], health care utilization, and pulmonary function testing (PFT's) including FEV1; FEV1/FVC, FEF25-75. CASI ranges from 0 (lowest) -20 points (highest) with a minimal clinically important difference of 0.49 points. The higher score is worse outcome."}], 'primaryOutcomes': [{'measure': 'Maximum Number of Days With Asthma Symptoms Within 2 Weeks', 'timeFrame': 'up to 12 months', 'description': 'Maximum number of\n\n1. Days with wheezing, tightness in the chest, or cough and/or\n2. Nights with disturbed sleep as a result of asthma and/or\n3. Days on which the child had to slow down or discontinue play activities because of asthma This is defined as a cumulative assessment from the different variables listed in the Measure Description'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '35688366', 'type': 'DERIVED', 'citation': 'Ruran HB, Maciag MC, Murphy SE, Phipatanakul W, Hauptman M. Cross-sectional study of urinary biomarkers of environmental tobacco and e-cigarette exposure and asthma morbidity. Ann Allergy Asthma Immunol. 2022 Sep;129(3):378-380. doi: 10.1016/j.anai.2022.06.001. Epub 2022 Jun 7. No abstract available.'}, {'pmid': '34547084', 'type': 'DERIVED', 'citation': 'Phipatanakul W, Koutrakis P, Coull BA, Petty CR, Gaffin JM, Sheehan WJ, Lai PS, Bartnikas LM, Kang CM, Wolfson JM, Samnaliev M, Cunningham A, Baxi SN, Permaul P, Hauptman M, Trivedi M, Louisias M, Liang L, Thorne PS, Metwali N, Adamkiewicz G, Israel E, Baccarelli AA, Gold DR; School Inner-City Asthma Intervention study team. Effect of School Integrated Pest Management or Classroom Air Filter Purifiers on Asthma Symptoms in Students With Active Asthma: A Randomized Clinical Trial. JAMA. 2021 Sep 7;326(9):839-850. doi: 10.1001/jama.2021.11559.'}, {'pmid': '29673798', 'type': 'DERIVED', 'citation': 'Kantor DB, Petty CR, Phipatanakul W, Gaffin JM. Transcutaneous CO-oximetry differentiates asthma exacerbation and convalescence in children. J Allergy Clin Immunol. 2018 Aug;142(2):676-678.e5. doi: 10.1016/j.jaci.2018.02.048. Epub 2018 Apr 16. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.', 'detailedDescription': 'Our proposal builds upon our established, successful school-based infrastructure to determine whether a school/classroom intervention will efficiently and effectively improve asthma morbidity by reducing these exposures. Our goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren. Our central hypothesis is that reducing classroom/school exposure to mouse allergen, mold, and particulate pollutants will decrease asthma morbidity in students with asthma. The investigators plan to test this hypothesis in an intervention study of 300 elementary students with asthma from multiple classrooms in inner-city elementary schools. Our clinical trial aims are to determine the effectiveness of a school/classroom based environmental intervention (school integrated pest management and classroom air purifying filter units within these schools) to reduce asthma morbidity. Our mechanistic aim is to test the hypothesis that effects of school/classroom-based environmental interventions on symptoms/other measures of asthma control occur through changes in gene methylation or expression in pathways (and secondarily, in genes) relevant to airway function and asthma. This will expand our understanding of asthma immunopathogenesis and create opportunities to identify potential novel targets for asthma therapy.'}, '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': 'NCT02291302', 'acronym': 'SICAS-2', 'briefTitle': 'School Inner-City Asthma Intervention Study (SICAS-2)', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'School Inner-City Asthma Intervention Study', 'orgStudyIdInfo': {'id': 'U01AI110397', 'link': 'https://reporter.nih.gov/quickSearch/U01AI110397', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01AI110397', 'link': 'https://reporter.nih.gov/quickSearch/U01AI110397', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Environmental Intervention', 'description': 'Active 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 (control)', 'description': 'Sham air purifiers and no school integrated pest management environmental intervention', 'interventionNames': ['Other: No intervention (control)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Active Air Purifier and Control', 'description': 'Active air purifiers and no school integrated pest management environmental intervention', 'interventionNames': ['Other: air purifier']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham and Inegrated Pest', 'description': 'Sham air purifiers and active 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 Inegrated Pest']}, {'name': 'air purifier', 'type': 'OTHER', 'description': 'air purifiers', 'armGroupLabels': ['Active Air Purifier and Control', 'Environmental Intervention']}, {'name': 'No intervention (control)', 'type': 'OTHER', 'description': 'no integrated pest management and sham air purifier', 'armGroupLabels': ['Sham and Control (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Wanda Phipatanakul, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Wanda Phipatanakul', 'investigatorAffiliation': "Boston Children's Hospital"}}}}