Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-31 @ 6:23 AM
Study NCT ID:
NCT03513068
Status:
TERMINATED
Last Update Posted:
2022-02-16
First Post:
2018-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maureen.crocker@resmed.com', 'phone': '+65 9815 2195', 'title': 'Maureen Crocker, Sr. Manager Market Access', 'organization': 'ResMed'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of the study = 12 weeks.', 'description': 'All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Of Care (SOC)', 'description': 'Standard of care long-term oxygen therapy', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 21, 'seriousNumAtRisk': 54, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'SOC + POC (Portable Oxygen Concentrator)', 'description': 'Standard of care long-term oxygen therapy + POC\n\nPortable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 16, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'COPD Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other respiratory-related condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'COPD Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other respiratory-related condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physical Activity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Of Care (SOC)', 'description': 'Standard of care long-term oxygen therapy'}, {'id': 'OG001', 'title': 'SOC + POC (Portable Oxygen Concentrator)', 'description': 'Standard of care long-term oxygen therapy + POC\n\nPortable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '232.1', 'groupId': 'OG000'}, {'value': '-84.6', 'spread': '1949.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change in physical activity level (PAL) as measured through actigraphy. Outcome measure is the change between the value at Week 12 and Day 1 (Baseline). Min = 0; Max = infinite. A large positive change would indicate the participant increased their activity level at 12 weeks in comparison to Day 1. Physical activity level (PAL) is the ratio of total energy expenditure (TEE) to sleep energy expenditure (SEE). TEE is the total number of wear-filtered kilocalories expended in a day and SEE is the total number of sleep- and wear-filtered kilocalories expended in a day.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only patients that had evaluable PAL data (via ActiGraph watch) at both baseline and 12 weeks.'}, {'type': 'SECONDARY', 'title': 'St. George Respiratory Questionnaire (SGRQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Of Care (SOC)', 'description': 'Standard of care long-term oxygen therapy'}, {'id': 'OG001', 'title': 'SOC + POC (Portable Oxygen Concentrator)', 'description': 'Standard of care long-term oxygen therapy + POC\n\nPortable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change in total SGRQ score between Week 12 and Baseline (Day1 ). Measures quality of life in patients with airway obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.', 'unitOfMeasure': 'score on a scale SGRQ', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only patients with evaluable and complete SGRQ data at both Baseline and Week 12.'}, {'type': 'SECONDARY', 'title': 'Oxygen Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Of Care (SOC)', 'description': 'Standard of care long-term oxygen therapy'}, {'id': 'OG001', 'title': 'SOC + POC (Portable Oxygen Concentrator)', 'description': 'Standard of care long-term oxygen therapy + POC\n\nPortable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change in Total Hours of Use', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS): Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Of Care (SOC)', 'description': 'Standard of care long-term oxygen therapy'}, {'id': 'OG001', 'title': 'SOC + POC (Portable Oxygen Concentrator)', 'description': 'Standard of care long-term oxygen therapy + POC\n\nPortable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Outcome measure is the change from Baseline (Day 1) and Week 12. HADS questionnaire measures anxiety and depression. A patient can score between 0-21, scores of less than 7 indicate non-cases.', 'unitOfMeasure': 'score on a scale HADS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes patients with complete HADS data at both Baseline and Week 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Of Care (SOC)', 'description': 'Standard of care long-term oxygen therapy'}, {'id': 'FG001', 'title': 'SOC + POC (Portable Oxygen Concentrator)', 'description': 'Standard of care long-term oxygen therapy + POC\n\nPortable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Of Care (SOC)', 'description': 'Standard of care long-term oxygen therapy'}, {'id': 'BG001', 'title': 'SOC + POC (Portable Oxygen Concentrator)', 'description': 'Standard of care long-term oxygen therapy + POC\n\nPortable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '70.2', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '68.8', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '30.2', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline characteristics were collected from all participants who signed the ICF; some of these participants did not complete the First study visit.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-29', 'size': 441970, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-21T04:52', 'hasProtocol': True}, {'date': '2020-08-18', 'size': 295227, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-21T04:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'whyStopped': 'COVID-19', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2018-04-11', 'resultsFirstSubmitDate': '2021-05-21', 'studyFirstSubmitQcDate': '2018-04-27', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-25', 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Level', 'timeFrame': '12 weeks', 'description': 'Change in physical activity level (PAL) as measured through actigraphy. Outcome measure is the change between the value at Week 12 and Day 1 (Baseline). Min = 0; Max = infinite. A large positive change would indicate the participant increased their activity level at 12 weeks in comparison to Day 1. Physical activity level (PAL) is the ratio of total energy expenditure (TEE) to sleep energy expenditure (SEE). TEE is the total number of wear-filtered kilocalories expended in a day and SEE is the total number of sleep- and wear-filtered kilocalories expended in a day.'}], 'secondaryOutcomes': [{'measure': 'St. George Respiratory Questionnaire (SGRQ)', 'timeFrame': '12 weeks', 'description': 'Change in total SGRQ score between Week 12 and Baseline (Day1 ). Measures quality of life in patients with airway obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.'}, {'measure': 'Oxygen Usage', 'timeFrame': '12 weeks', 'description': 'Change in Total Hours of Use'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS): Anxiety', 'timeFrame': '12 weeks', 'description': 'Outcome measure is the change from Baseline (Day 1) and Week 12. HADS questionnaire measures anxiety and depression. A patient can score between 0-21, scores of less than 7 indicate non-cases.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['COPD', 'POC', 'Oxygen', 'QoL'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'To evaluate changes in activity based on the use of portable oxygen concentrators combined with standard of care (SOC) long- term oxygen therapy versus SOC long-term oxygen therapy alone at 12 weeks in patients with COPD who require continuous (24/7) long-term oxygen therapy. The study will also assess oxygen usage, quality of life, hospitalizations and death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is 40 years or older.\n2. Patient has a documented diagnosis of COPD.\n3. Patient qualifies for continuous (24/7) long-term oxygen therapy.\n4. Patient is prescribed oxygen at ≤ 5 L/min.\n5. Patient is POC-naïve, i.e., has not used a POC prior to enrolling in this study.\n6. Patient is able to tolerate pulsed oxygen therapy, i.e., oxygen delivered via a POC.\n7. Patient is able to fully understand study information and provide signed informed consent and HIPAA authorization.\n\nExclusion Criteria:\n\n1. Patient's condition is contraindicated for the use of a POC.\n2. Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated.\n3. Patient is unable to complete the 6-minute walk test.\n4. Patient has a diagnosis (within less than two weeks prior to study entry) of pneumonia or respiratory infection, and/or acute bronchitis requiring antibiotics, or new/increased dose of systemic corticosteroids.\n5. Patient has had thoracic surgery or another procedure in the six months prior to enrollment that is likely to cause instability of pulmonary status.\n6. Patient has an open skin ulcer or rash where the activity monitor will be worn on the body.\n7. Patient has a life expectancy \\< 1 year.\n8. Patient has non-COPD lung disease that may affect oxygenation or survival.\n9. Patient has a planned intervention(s) requiring hospitalization within the three months of study participation.\n10. Patient is pregnant or planning to become pregnant.\n11. Patient is participating in a clinical study of a medical product and has not completed the required follow-up period.\n12. Patient, in the opinion of the investigator, should be excluded from the study."}, 'identificationModule': {'nctId': 'NCT03513068', 'acronym': 'POC-STEP', 'briefTitle': 'Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)', 'orgStudyIdInfo': {'id': 'MA-16-05-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Of Care (SOC)', 'description': 'Standard of care long-term oxygen therapy'}, {'type': 'EXPERIMENTAL', 'label': 'SOC + POC (Portable Oxygen Concentrator)', 'description': 'Standard of care long-term oxygen therapy + POC', 'interventionNames': ['Device: Portable Oxygen Concentrator (POC)']}], 'interventions': [{'name': 'Portable Oxygen Concentrator (POC)', 'type': 'DEVICE', 'description': 'COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)', 'armGroupLabels': ['SOC + POC (Portable Oxygen Concentrator)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois, Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Airways', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40218', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Research Group', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'ClinSite LLC', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Lung Center', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Lung Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55125', 'city': 'Woodbury', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Lung Center', 'geoPoint': {'lat': 44.92386, 'lon': -92.95938}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Clinical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Emphysema/COPD Research Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'MaryKay Sobcinski', 'role': 'STUDY_CHAIR', 'affiliation': 'RCRI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Inogen Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}