Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-25 @ 5:39 PM
Study NCT ID:
NCT02712333
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Health Effects of Indoor Air Filtration in Healthy Chinese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'kanh@fudan.edu.cn', 'phone': '86-21-54237908', 'title': 'Dr. Haidong Kan', 'organization': 'Fudan University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Real Air Purification', 'description': 'Participants in this group received an intervention of true air purifiers placed in the center of the room.\n\nReal Air Purification: The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment.', 'otherNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Air Purification', 'description': 'Participants in this group received an intervention of sham air purifiers, which were under the same conditions as the true purifiers except the filter gauze in them were removed.\n\nSham Air Purification: This group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed. All participants and research staffs were blinded to the group assignment.', 'otherNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes of Serum Cortisol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Purification', 'description': 'Participants in this group received a treatment of air purification.'}, {'id': 'OG001', 'title': 'Sham Purification', 'description': 'Participants received sham air purification first.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.012835', 'spread': '0.00371', 'groupId': 'OG000'}, {'value': '0.016206', 'spread': '0.00474', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': '% increase per 10μg/m3 increase of PM2.5', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.53', 'ciLowerLimit': '4.65', 'ciUpperLimit': '10.41', 'pValueComment': 'the p-value has been adjusted for multiple comparisons', 'groupDescription': 'we analyzed the serum cortisol levels (presented as relative intensities in high perfomance liquid chromatography-mass spectrum) by treatments (intervention group vs control group)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fold change', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.33', 'estimateComment': 'fold change is calculated by measurments from the sham purification group/measurements from the real purification group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'at the end of each 9-day intervention period', 'description': 'Using metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\n\nRelative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)', 'unitOfMeasure': 'relative intensity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes of Serum Cortisone Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Purification', 'description': 'Participants received a treatment of air purification'}, {'id': 'OG001', 'title': 'Sham Purification', 'description': 'Participants received a treatment of sham air purification'}], 'classes': [{'categories': [{'measurements': [{'value': '0.021076', 'spread': '0.004375', 'groupId': 'OG000'}, {'value': '0.024338', 'spread': '0.004625', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': '% increase per 10μg/m3 increase of PM2.5', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.69', 'ciLowerLimit': '1.85', 'ciUpperLimit': '5.54', 'pValueComment': 'the p-value has been adjusted for multiple comparisons.', 'groupDescription': 'we analyzed the serum cortisone levels by treatment (intervention group vs control group)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fold change', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.18', 'estimateComment': 'fold change is calculated by measurments from the sham purification group/measurements from the real purification group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'at the end of each 9-day intervention period', 'description': 'Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\n\nRelative intensity was calculated by dividing the peak intensity of cortisone with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)', 'unitOfMeasure': 'relative intensity', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes of Serum Epinephrine Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Purification', 'description': 'Participants received a treatment of real air purification.'}, {'id': 'OG001', 'title': 'Sham Air Purification', 'description': 'Participants received a treatment of sham air purification.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.140609', 'spread': '0.027514', 'groupId': 'OG000'}, {'value': '0.165321', 'spread': '0.036633', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': '% increase per 10μg/m3 increase of PM2.5', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.17', 'ciLowerLimit': '3.21', 'ciUpperLimit': '7.14', 'pValueComment': 'the p-value has been adjusted for multiple comparisons.', 'groupDescription': 'we analyzed the serum epinephrine levels by treatment (intervention group vs control group)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fold change', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.20', 'estimateComment': 'fold change is calculated by measurments from the sham purification group/measurements from the real purification group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'at the end of each 9-day intervention', 'description': 'Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\n\nRelative intensity was calculated by dividing the peak intensity of epinephrine with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)', 'unitOfMeasure': 'relative intensity', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes of Serum Norepinephrine Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Purification', 'description': 'Participants received a treatment of air purification'}, {'id': 'OG001', 'title': 'Sham Purification', 'description': 'Participants received a treatment of sham air purification'}], 'classes': [{'categories': [{'measurements': [{'value': '0.030752', 'spread': '0.024335', 'groupId': 'OG000'}, {'value': '0.038695', 'spread': '0.024624', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': '% increase per 10μg/m3 increase of PM2.5', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.28', 'ciLowerLimit': '7.37', 'ciUpperLimit': '15.21', 'pValueComment': 'the p-value has been adjusted for multiple comparisons', 'groupDescription': 'we analyzed the serum norepinephrine levels by treatment (intervention group vs control group)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'fold change', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.57', 'estimateComment': 'fold change is calculated by measurments from the sham purification group/measurements from the real purification group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'at the end of each 9-day intervention', 'description': 'Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\n\nRelative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)', 'unitOfMeasure': 'relative intensity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Purification', 'description': 'Participants received a treatment of air purification'}, {'id': 'OG001', 'title': 'Sham Purification', 'description': 'Participants received a treatment of sham air purification'}], 'classes': [{'categories': [{'measurements': [{'value': '102.2', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '104.8', 'spread': '12.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': '% increase per 10μg/m3 increase of PM2.5', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.09', 'ciUpperLimit': '1.59', 'groupDescription': 'we analyzed the serum SBP levels by treatment (intervention group vs control group)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'at the end of each 9-day intervention period', 'description': 'To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Purification', 'description': 'Participants received a treatment of air purification'}, {'id': 'OG001', 'title': 'Sham Air Purification', 'description': 'Participants received a treatment of sham air purification'}], 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '65.2', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': '% increase per 10μg/m3 increase of PM2.5', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '0.96', 'groupDescription': 'we analyzed the serum cortisol levels by treatment (intervention group vs control group)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'at the end of each 9-day intervention', 'description': 'To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pulse Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Purification', 'description': 'Participants received a treatment of air purification'}, {'id': 'OG001', 'title': 'Sham Air Purification', 'description': 'Participants received a treatment of sham air purification'}], 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': '% increase per 10μg/m3 increase of PM2.5', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '3.63', 'groupDescription': 'we analyzed the serum cortisol levels by treatment (intervention group vs control group)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'at the end of each 9-day intervention', 'description': 'To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1-air Purification First, Then Sham Air Purification', 'description': 'Participants in this group received an intervention of true air purifiers placed in the center of the room.\n\nReal Air Purification: The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment.'}, {'id': 'FG001', 'title': 'Group2-sham Air Purification First, Then Real Air Purification', 'description': 'Participants in this group received an intervention of sham air purifiers, which were under the same conditions as the true purifiers except the filter gauze in them were removed.\n\nSham Air Purification: This group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms as much as possible with the windows/doors closed. All participants and research staffs were blinded to the group assignment.'}], 'periods': [{'title': 'First Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Second Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment was conducted on November, 2015 in Jiangwan Campus, Fudan University. A total of 65 participants were assessed for eligibility and 60 of them were finally recruited'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group1-air Purification First, Then Sham Air Purification', 'description': 'Participants in this group received a treatment of true air purification first, and then switched to the sham purification treatment the second stage.\n\nFor real air purification, we used high efficient air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. For sham air purification, we placed a sham air purifier (with HEPA filters removed) while keeping the rest of the experiment conditions and requirements for the participants unchanged. All participants and research staffs were blinded to the group assignment.'}, {'id': 'BG001', 'title': 'Group2-sham Air Purification First, Then Real Air Purification', 'description': 'Participants in this group received a treatment of sham air purification first, and then switched to the real purification treatment the second stage.\n\nFor real air purification, we used high efficient air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. For sham air purification, we placed a sham air purifier (with HEPA filters removed) while keeping the rest of the experiment conditions and requirements for the participants unchanged. All participants and research staffs were blinded to the group assignment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '20.6', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '20.2', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '20.6', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '21.1', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-05', 'studyFirstSubmitDate': '2016-02-01', 'resultsFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-05', 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Serum Cortisol Levels', 'timeFrame': 'at the end of each 9-day intervention period', 'description': 'Using metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\n\nRelative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)'}, {'measure': 'Changes of Serum Cortisone Concentration', 'timeFrame': 'at the end of each 9-day intervention period', 'description': 'Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\n\nRelative intensity was calculated by dividing the peak intensity of cortisone with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)'}, {'measure': 'Changes of Serum Epinephrine Concentrations', 'timeFrame': 'at the end of each 9-day intervention', 'description': 'Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\n\nRelative intensity was calculated by dividing the peak intensity of epinephrine with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)'}, {'measure': 'Changes of Serum Norepinephrine Concentration', 'timeFrame': 'at the end of each 9-day intervention', 'description': 'Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\n\nRelative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'at the end of each 9-day intervention period', 'description': 'To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'at the end of each 9-day intervention', 'description': 'To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).'}, {'measure': 'Pulse Pressure', 'timeFrame': 'at the end of each 9-day intervention', 'description': 'To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PM2.5', 'air purification', 'randomized controlled trial', 'metabolomics', 'Metabolites', 'exhaled nitric oxide'], 'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '28808144', 'type': 'DERIVED', 'citation': 'Li H, Cai J, Chen R, Zhao Z, Ying Z, Wang L, Chen J, Hao K, Kinney PL, Chen H, Kan H. Particulate Matter Exposure and Stress Hormone Levels: A Randomized, Double-Blind, Crossover Trial of Air Purification. Circulation. 2017 Aug 15;136(7):618-627. doi: 10.1161/CIRCULATIONAHA.116.026796.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to detect serum metabolite changes, as well as other health indicators with the intervention of air purifiers on a randomized, crossover, double-blind trial.', 'detailedDescription': 'The investigators conducted a randomized double-blind crossover trial among 60 healthy college students in Shanghai, China from November to December, 2015. These students lived in dormitories that were randomized into two groups and alternated the use of true or sham air purifiers for 9 consecutive days with a 2-week wash-out interval. All participants and research staffs were blinded to the group assignment. All participants were required to stay in their dormitory with the windows/doors closed for at least 50% of the time on weekdays and for 80% on weekends throughout the 9-day intervention period. All interventions started at 7 a.m. to avoid issues related to diurnal variation. Health endpoints, including blood pressure, fractional exhaled nitric oxide were evaluated and biological samples such as morning urine, fast blood and buccal cells were collected at baseline and immediately after the completion of each intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy university students in Jiangwan Campus, Fudan university\n* Non-smoking, no history of alcohol or drug abuse\n* Free of chronic cardiovascular, respiratory, liver and kidney disease\n* Spend at least 50% (weekdays) or 80% (weekends) of time indoors\n\nExclusion Criteria:\n\n* Current or ever smokers\n* History of asthma, chronic bronchitis，cough, hypertension or other chronic inflammatory disease\n* acute infections\n* medication use in recent one month'}, 'identificationModule': {'nctId': 'NCT02712333', 'briefTitle': 'Health Effects of Indoor Air Filtration in Healthy Chinese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Health Effects of Indoor Air Filtration in Healthy Chinese Adults: An Intervention Study', 'orgStudyIdInfo': {'id': 'FDEH-AF2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Air purifiers', 'description': 'Participants in this group received an intervention of true air purifiers placed in the center of the room.', 'interventionNames': ['Behavioral: Air Purifiers']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Participants in this group received an intervention of sham air purifiers, which were under the same conditions as the true purifiers except the filter gauze in them were removed.', 'interventionNames': ['Behavioral: Sham Air Purifiers']}], 'interventions': [{'name': 'Air Purifiers', 'type': 'BEHAVIORAL', 'description': 'The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment.', 'armGroupLabels': ['Air purifiers']}, {'name': 'Sham Air Purifiers', 'type': 'BEHAVIORAL', 'description': 'The control group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms with the windows/doors closed. All participants and research staffs were blinded to the group assignment.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Environmental Health, School of Public Health, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Haidong Kan, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'School of Public Health，Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Haidong Kan', 'investigatorAffiliation': 'Fudan University'}}}}