Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT04107493
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2019-09-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-21', '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': '+1 8588366653', 'title': 'maureen crocker', 'organization': 'ResMed'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the one study visit. After completion of this visit, the participants involvement in the study was completed', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Oxygen Cylinder', 'description': 'Participants acted as their own control in this study.\n\nParticipants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC\n\nPortable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mobi', 'description': 'Participants acted as their own control in this study.\n\nParticipants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC\n\nPortable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portable Oxygen Cylinder', 'description': 'Continuous flow oxygen cylinders will be used as a comparison.\n\nPortable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients'}, {'id': 'OG001', 'title': 'Mobi™ Portable Oxygen Concentrator', 'description': "Mobi™ is indicated for patients who require supplemental oxygen, including COPD patients. It provides supplemental, high oxygen concentration to these patients. It is available via prescription only and may be used in the home, institution, and hospital settings, as well as travel environments\n\nMobi: ResMed's variant of POC"}], 'classes': [{'categories': [{'measurements': [{'value': '91.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '90.0', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Mean Sp02, measured during 6 minute walk test', 'description': "Each subject's SpO2 will be measured when each subject takes six minutes walk test", 'unitOfMeasure': 'percentage of oxygen saturation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Portable Oxygen Cylinder, Then Mobi', 'description': 'Participants acted as their own control in this study.\n\nParticipants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC\n\nPortable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients'}, {'id': 'FG001', 'title': 'Mobi, Then Portable Oxygen Cylinder', 'description': 'Participants acted as their own control in this study.\n\nParticipants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC\n\nPortable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients'}], 'periods': [{'title': 'First Intervention (1 Hour)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (One Hour)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants acted as their own controls. Participants were randomised as to the order they used the devices during the 6-minute walking test. There was a one hour wash out period between tests'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants acted as their own control during this study. Participants used a portable oxygen cylinder whilst doing a 6 minute walking test. After a wash out period the participants completed the 6 minute walking test with the second portable oxygen cylinder. The order of the oxygen cylinders (mobi or standard) was randomised'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.86', 'spread': '8.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'COPD adult patients with long term oxygen therapy history were included. They were all stable (at least 4 weeks since last exacerbation episode).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-15', 'size': 1178570, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-23T23:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a prospective, randomized, cross-over study design with participants serving as their own controls. A within- participants, repeated-measures design is used during 6MWT. Eligible participants will complete two 6MWTs: one with their usual portable oxygen cylinder, and one with Mobi™. All participants entered into the study will be randomized in a 1:1 ratio to the following order of device use:\n\n* Control device (portable oxygen cylinder) first; or\n* Study device (Mobi™, POC) first.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2019-09-24', 'resultsFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2019-09-26', 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-24', 'studyFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)', 'timeFrame': 'Mean Sp02, measured during 6 minute walk test', 'description': "Each subject's SpO2 will be measured when each subject takes six minutes walk test"}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '31404750', 'type': 'BACKGROUND', 'citation': 'Gloeckl R, Jarosch I, Schneeberger T, Fiedler C, Lausen M, Weingaertner J, Hitzl W, Kenn K, Koczulla AR. Comparison of supplemental oxygen delivery by continuous versus demand based flow systems in hypoxemic COPD patients - A randomized, single-blinded cross-over study. Respir Med. 2019 Sep;156:26-32. doi: 10.1016/j.rmed.2019.08.001. Epub 2019 Aug 5.'}, {'pmid': '18686732', 'type': 'BACKGROUND', 'citation': 'Guell Rous R. Long-term oxygen therapy: are we prescribing appropriately? Int J Chron Obstruct Pulmon Dis. 2008;3(2):231-7. doi: 10.2147/copd.s1230.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized study with a cross-over design. Mobi™ is a relatively new POC in the market and thus it is valuable to collect data from COPD patients using supplemental oxygen, and their use on Mobi™. The purpose of the present study is to compare Mobi™ with a continuous flow oxygen cylinder, with SpO2 as the primary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n2. Male or female, age ≥ 18 years at the time of signing informed consent.\n3. Diagnosed with COPD and currently in a stable state (at least 4 weeks since last exacerbation episode22).\n4. Current prescription for long-term oxygen therapy.\n5. Participants meet the criteria for pulse-dose portable oxygen delivery, defined as being mobile within the home and the qualifying blood gas study was performed at rest/ awake or during exercise.\n6. Participants who can read and comprehend English.\n\nExclusion Criteria:\n\n1. Clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol.\n2. Current oxygen therapy prescription for \\>5 L/min continuous flow.\n3. Known or suspected contraindication for pulse-dose oxygen.\n4. Unable to complete 6MWTs, e.g., unstable angina and myocardial infarction during the previous month\n5. Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)."}, 'identificationModule': {'nctId': 'NCT04107493', 'briefTitle': 'Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)', 'orgStudyIdInfo': {'id': 'MA-19-03-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Portable oxygen cylinder', 'description': 'Continuous flow oxygen cylinders will be used as a comparison.', 'interventionNames': ['Device: Portable Oxygen Cylinder']}, {'type': 'EXPERIMENTAL', 'label': 'Mobi™ Portable Oxygen Concentrator', 'description': 'Mobi™ is indicated for patients who require supplemental oxygen, including COPD patients. It provides supplemental, high oxygen concentration to these patients. It is available via prescription only and may be used in the home, institution, and hospital settings, as well as travel environments', 'interventionNames': ['Device: Mobi']}], 'interventions': [{'name': 'Portable Oxygen Cylinder', 'type': 'DEVICE', 'otherNames': ['POC'], 'description': 'A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients', 'armGroupLabels': ['Portable oxygen cylinder']}, {'name': 'Mobi', 'type': 'DEVICE', 'otherNames': ['Mobi POC'], 'description': "ResMed's variant of POC", 'armGroupLabels': ['Mobi™ Portable Oxygen Concentrator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'SleepData', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Samuel Clark, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SleepData'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}