Viewing Study NCT05087693


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Study NCT ID: NCT05087693
Status: COMPLETED
Last Update Posted: 2025-03-14
First Post: 2021-09-28
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)
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': 'D000420', 'term': 'Albuterol'}, {'id': 'D010126', 'term': 'Ozone'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.koehle@ubc.ca', 'phone': '8229331', 'title': 'Michael Koehle', 'organization': 'UNiversity of BRitish COlumbia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Over the period from recruitment to completion of data collection for each individual. Five visits total over a period of approximately 10 days to 6 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Exercising in Ozone Following Salbutamol Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.\n\nSalbutamol: Inhaling 200ug of salbutamol\n\nOzone: Breathing 170ppb ozone\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exercising in Filtered Air Following Salbutamol Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.\n\nSalbutamol: Inhaling 200ug of salbutamol\n\nFiltered Air: Breathing filtered air\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Exercising in Ozone Following Placebo Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.\n\nPlacebo medication: Inhaling placebo medication\n\nOzone: Breathing 170ppb ozone\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Exercising in Filtered Air Following Placebo Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.\n\nPlacebo medication: Inhaling placebo medication\n\nFiltered Air: Breathing filtered air\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measured Before and 30 Minutes After Exercise in Each 1 Day Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercising in Ozone Following Salbutamol Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.\n\nSalbutamol: Inhaling 200ug of salbutamol\n\nOzone: Breathing 170ppb ozone\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer'}, {'id': 'OG001', 'title': 'Exercising in Filtered Air Following Salbutamol Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.\n\nSalbutamol: Inhaling 200ug of salbutamol\n\nFiltered Air: Breathing filtered air\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer'}, {'id': 'OG002', 'title': 'Exercising in Ozone Following Placebo Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.\n\nPlacebo medication: Inhaling placebo medication\n\nOzone: Breathing 170ppb ozone\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer'}, {'id': 'OG003', 'title': 'Exercising in Filtered Air Following Placebo Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.\n\nPlacebo medication: Inhaling placebo medication\n\nFiltered Air: Breathing filtered air\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer'}], 'classes': [{'categories': [{'measurements': [{'value': '6.98', 'groupId': 'OG000', 'lowerLimit': '5.25', 'upperLimit': '8.71'}, {'value': '5.96', 'groupId': 'OG001', 'lowerLimit': '4.23', 'upperLimit': '7.69'}, {'value': '-1.38', 'groupId': 'OG002', 'lowerLimit': '-3.12', 'upperLimit': '.35'}, {'value': '-.35', 'groupId': 'OG003', 'lowerLimit': '-2.08', 'upperLimit': '1.39'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured before and 30 minutes after exercise in each 1 day condition', 'description': 'Measure of pulmonary function', 'unitOfMeasure': 'litres', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Entire study population'}, {'type': 'PRIMARY', 'title': 'Change in FVC From Baseline to 30 Minutes After Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercising in Ozone Following Salbutamol Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.\n\nSalbutamol: Inhaling 200ug of salbutamol\n\nOzone: Breathing 170ppb ozone\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer'}, {'id': 'OG001', 'title': 'Exercising in Filtered Air Following Salbutamol Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.\n\nSalbutamol: Inhaling 200ug of salbutamol\n\nFiltered Air: Breathing filtered air\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer'}, {'id': 'OG002', 'title': 'Exercising in Ozone Following Placebo Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.\n\nPlacebo medication: Inhaling placebo medication\n\nOzone: Breathing 170ppb ozone\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer'}, {'id': 'OG003', 'title': 'Exercising in Filtered Air Following Placebo Inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.\n\nPlacebo medication: Inhaling placebo medication\n\nFiltered Air: Breathing filtered air\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer'}], 'classes': [{'categories': [{'measurements': [{'value': '.77', 'groupId': 'OG000', 'lowerLimit': '-.14', 'upperLimit': '1.67'}, {'value': '.39', 'groupId': 'OG001', 'lowerLimit': '-.51', 'upperLimit': '1.29'}, {'value': '-1.37', 'groupId': 'OG002', 'lowerLimit': '-2.28', 'upperLimit': '-.47'}, {'value': '-1.44', 'groupId': 'OG003', 'lowerLimit': '-2.35', 'upperLimit': '-.54'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured before and 30 minutes after exercise in each 1 day condition', 'description': 'Measure of pulmonary function', 'unitOfMeasure': 'litres', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer on four occasions in random order.\n\nOn one of the occasions they will exercise while inhaling 170ppb ozone after inhaling 200ug of salbutamol.\n\nOn one of the occasions they will exercise while inhaling 170ppb ozone after inhaling one puff of placebo.\n\nOn one of the occasions they will exercise while room air after inhaling 200ug of salbutamol.\n\nOn one of the occasions they will exercise while inhaling room air after inhaling one puff of placebo.\n\nExercise: Cycling at 60% of VO2max on a cycle ergometer\n\nDue to the randomised nature there will be more than six possible sequences of these four exposures, thus as per guidance from clinical trials.gov we will use a single arm/group for the participant flow.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Ozone/Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Ozone/Salbutamol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Clean Air/Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Clean Air/Salbutamol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Individuals without EIB were excluded. 23 tested positive for EIB, but only 18 were ultimately enrolled and scheduled for testing.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All participants who screened positive and included in the 4 testing bouts.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.5', 'spread': '5.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-28', 'size': 264087, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-09T08:14', 'hasProtocol': True}, {'date': '2022-02-14', 'size': 345530, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-04T17:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Drug condition (placebo or salbutamol) will be double blinded Air quality condition (ozone or filtered air) will be single blinded'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2021-09-28', 'resultsFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-26', 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measured Before and 30 Minutes After Exercise in Each 1 Day Condition', 'timeFrame': 'Measured before and 30 minutes after exercise in each 1 day condition', 'description': 'Measure of pulmonary function'}, {'measure': 'Change in FVC From Baseline to 30 Minutes After Exercise', 'timeFrame': 'Measured before and 30 minutes after exercise in each 1 day condition', 'description': 'Measure of pulmonary function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Exercise Induced Bronchoconstriction', 'Salbutamol', 'Ozone'], 'conditions': ['Asthma and/or Exercise Induced Bronchoconstriction', 'Ozone Air Pollution']}, 'descriptionModule': {'briefSummary': 'Salbutamol use is increased in areas with high levels of ozone pollution and the potential consequences of this are not well known. The purpose of this study is to examine the effect of salbutamol on lung function and inflammation in people with asthma and/or EIB exercising in ozone air pollution. To examine this, we are planning a randomized cross over trial where people with asthma and/or EIB complete sub maximal exercise in four conditions on four separate days. The four condition are: ozone + salbutamol, filtered air + salbutamol, ozone + placebo medication, and filtered air + placebo medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have asthma and/or EIB\n* Able to perform maximal exercise\n* Able to communicate sufficiently using the English language\n\nExclusion Criteria:\n\n* Allergic to salbutamol (also known as Ventolin)\n* Pregnant or potentially pregnant\n* Have a history of smoking\n* Had an upper respiratory tract infection within the last 4 weeks\n* Have a chronic respiratory disease other than asthma or EIB'}, 'identificationModule': {'nctId': 'NCT05087693', 'briefTitle': 'Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Examining the Effect of Salbutamol Use in Asthma and/or Exercise Induced Bronchoconstriction Whilst Exercising in Ozone Air Pollution', 'orgStudyIdInfo': {'id': 'H21-01080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercising in ozone following salbutamol inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.', 'interventionNames': ['Drug: Salbutamol', 'Other: Ozone', 'Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercising in filtered air following salbutamol inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.', 'interventionNames': ['Drug: Salbutamol', 'Other: Filtered Air', 'Other: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Exercising in ozone following placebo inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.', 'interventionNames': ['Drug: Placebo medication', 'Other: Ozone', 'Other: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Exercising in filtered air following placebo inhalation', 'description': 'Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.', 'interventionNames': ['Drug: Placebo medication', 'Other: Filtered Air', 'Other: Exercise']}], 'interventions': [{'name': 'Salbutamol', 'type': 'DRUG', 'description': 'Inhaling 200ug of salbutamol', 'armGroupLabels': ['Exercising in filtered air following salbutamol inhalation', 'Exercising in ozone following salbutamol inhalation']}, {'name': 'Placebo medication', 'type': 'DRUG', 'description': 'Inhaling placebo medication', 'armGroupLabels': ['Exercising in filtered air following placebo inhalation', 'Exercising in ozone following placebo inhalation']}, {'name': 'Ozone', 'type': 'OTHER', 'description': 'Breathing 170ppb ozone', 'armGroupLabels': ['Exercising in ozone following placebo inhalation', 'Exercising in ozone following salbutamol inhalation']}, {'name': 'Filtered Air', 'type': 'OTHER', 'description': 'Breathing filtered air', 'armGroupLabels': ['Exercising in filtered air following placebo inhalation', 'Exercising in filtered air following salbutamol inhalation']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'Cycling at 60% of VO2max on a cycle ergometer', 'armGroupLabels': ['Exercising in filtered air following placebo inhalation', 'Exercising in filtered air following salbutamol inhalation', 'Exercising in ozone following placebo inhalation', 'Exercising in ozone following salbutamol inhalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 1Z1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Environmental Physiology Laboratory', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Any data shared will not contain any personal identifiers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael Koehle', 'investigatorAffiliation': 'University of British Columbia'}}}}