Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-01-10 @ 3:37 PM
Study NCT ID:
NCT02719158
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2016-03-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Ranging Study of OTO-201 in AOMT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@otonomy.com', 'phone': '1-800-826-6411', 'title': 'Medical Information Call Center', 'organization': 'Otonomy, Inc.'}, 'certainAgreement': {'otherDetails': 'Publication subject to Sponsor consent.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported during dosing and up to 1 month following dosing.', 'eventGroups': [{'id': 'EG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration of OTO-201', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 5, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration of OTO-201', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 6, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control', 'description': 'Sham Control: simulated, single administration', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'OG002', 'title': 'Control', 'description': 'Sham Control: simulated, single administration'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 month', 'description': 'Number of subjects with adverse events during the study from dosing up to 1 month after dosing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all subjects who received study drug.'}, {'type': 'PRIMARY', 'title': 'Otoscopic Examination: Auricle and Meatus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}, {'units': 'normal affected ears at Baseline', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'OG002', 'title': 'Control', 'description': 'Sham Control: simulated, single administration'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure).', 'unitOfMeasure': 'abnormal affected ears at Day 29', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'normal affected ears at Baseline', 'denomUnitsSelected': 'normal affected ears at Baseline', 'populationDescription': 'Safety Population (19 sham, 38 6mg, 38 12 mg) who could have had one or 2 affected ears at Baseline (that is, it was not necessary for both ears to be infected to take part in the study). This is why the number of ears in each group do not equal twice the number of participants.'}, {'type': 'PRIMARY', 'title': 'Otoscopic Examination: Tympanic Membrane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}, {'units': 'normal affected ears at Baseline', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'OG002', 'title': 'Control', 'description': 'Sham Control: simulated, single administration'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure).', 'unitOfMeasure': 'abnormal ears at Day 29', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'normal affected ears at Baseline', 'denomUnitsSelected': 'normal affected ears at Baseline', 'populationDescription': 'Safety Population (19 sham, 38 6mg, 38 12 mg) who could have had one or 2 affected ears at Baseline (that is, it was not necessary for both ears to be infected to take part in the study). This is why the number of ears in each group do not equal twice the number of participants.'}, {'type': 'SECONDARY', 'title': 'Absence of Otorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'OG002', 'title': 'Control', 'description': 'Sham Control: simulated, single administration'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Two Weeks', 'description': 'Absence of otorrhea (middle ear drainage)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat analysis set: all subjects who were randomized, received treatment, did not have group A streptococci cultured on Visit 1 (Day 1), and had at least 1 on-therapy visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'FG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'FG002', 'title': 'Control', 'description': 'Sham Control: simulated, single administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'BG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration of OTO-201'}, {'id': 'BG002', 'title': 'Control', 'description': 'Sham Control: simulated, single administration'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.004', 'spread': '3.0546', 'groupId': 'BG000'}, {'value': '3.955', 'spread': '2.9111', 'groupId': 'BG001'}, {'value': '3.551', 'spread': '2.4583', 'groupId': 'BG002'}, {'value': '3.498', 'spread': '2.8915', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '95 subjects randomized (19 sham, 38 6mg, 3812mg OTO-201). 1 sham and 1 6mg subject positive for Group A strep and not in intento to treat (ITT) population (Baseline and efficacy) leaving 18 sham, 37-6mg OTO-201, 38-12 mg OTO-201 in ITT. Safety population (AE/SAE) = randomized (19 sham, 38 6mg, 38 12mg).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2016-03-21', 'resultsFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2016-03-21', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-01', 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Adverse Events', 'timeFrame': 'Up to 1 month', 'description': 'Number of subjects with adverse events during the study from dosing up to 1 month after dosing'}, {'measure': 'Otoscopic Examination: Auricle and Meatus', 'timeFrame': 'Up to 1 month', 'description': 'Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure).'}, {'measure': 'Otoscopic Examination: Tympanic Membrane', 'timeFrame': 'Up to 1 month', 'description': 'Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure).'}], 'secondaryOutcomes': [{'measure': 'Absence of Otorrhea', 'timeFrame': 'Up to Two Weeks', 'description': 'Absence of otorrhea (middle ear drainage)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute otitis media with tympanostomy tubes', 'OTIPRIO'], 'conditions': ['Acute Otitis Media', 'AOMT']}, 'descriptionModule': {'briefSummary': 'Dose Ranging Study of OTO-201 in AOMT', 'detailedDescription': 'This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria includes, but is not limited to:\n\n* Subject is a male or female aged 6 months to 17 years, inclusive\n* Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)\n* Subject's caregiver is willing to comply with the protocol an attend all study visits\n\nExclusion Criteria includes, but is not limited to:\n\n* Subject has a history of sensorineural hearing loss\n* Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation\n* Subject has a history of known immunodeficiency disease"}, 'identificationModule': {'nctId': 'NCT02719158', 'briefTitle': 'Dose Ranging Study of OTO-201 in AOMT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otonomy, Inc.'}, 'officialTitle': 'A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects', 'orgStudyIdInfo': {'id': '201-201508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6 mg OTO-201', 'description': '6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s)', 'interventionNames': ['Drug: 6 mg ciprofloxacin']}, {'type': 'EXPERIMENTAL', 'label': '12 mg OTO-201', 'description': '12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s)', 'interventionNames': ['Drug: 12 mg ciprofloxacin']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham (empty syringe)', 'description': 'Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': '6 mg ciprofloxacin', 'type': 'DRUG', 'otherNames': ['OTIPRIO'], 'description': 'Single administration of OTO-201', 'armGroupLabels': ['6 mg OTO-201']}, {'name': '12 mg ciprofloxacin', 'type': 'DRUG', 'otherNames': ['OTIPRIO'], 'description': 'Single administration of OTO-201', 'armGroupLabels': ['12 mg OTO-201']}, {'name': 'Sham', 'type': 'OTHER', 'armGroupLabels': ['Sham (empty syringe)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Contact Otonomy call center for trial locations', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Carl LeBel, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Otonomy, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otonomy, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}