Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT03267992
Status:
TERMINATED
Last Update Posted:
2021-07-16
First Post:
2017-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], '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'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Study enrollment was prematurely stopped for business reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of COPD Exacerbation', 'timeFrame': '12 months', 'description': 'Rate of COPD Exacerbation serious adverse events (SAEs) reported in the 12-month period following the initial Endobronchial Coil procedure for participants enrolled in CLN0020 when compared to CLN0014 participant population that was not managed utilizing COPD Co-Pilot AIR.'}], 'secondaryOutcomes': [{'measure': 'Respiratory Related SAEs', 'timeFrame': '12 months', 'description': 'Percent of participants experiencing one or more respiratory-related SAEs in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants in CLN0014.'}, {'measure': 'Rate of First Respiratory-Related SAEs', 'timeFrame': '12 months', 'description': 'Rate of first respiratory-related SAEs reported in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014.'}, {'measure': 'Time to First Respiratory-Related SAE', 'timeFrame': '12 months', 'description': 'Time to first respiratory-related SAE following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Coils', 'App'], 'conditions': ['COPD Symptoms After Coil Procedure']}, 'descriptionModule': {'briefSummary': 'The purpose of undertaking CLN0020, which was a Substudy of the European Coil registry (CLN0014), was to investigate the use of COPD Co-Pilot AIR™, a COPD disease management program manufactured and operated by HGE Health Care Solutions, LLC, in participants undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.', 'detailedDescription': 'COPD Co-Pilot AIR™ combines a digital respiratory symptom reporting participant application (an "app") with facilitation of rapid personalized clinical recommendations made by the participant\'s health care provider and communicated to the participant through the application. COPD Co-Pilot AIR™ provides early identification of an increase in a participant\'s respiratory symptoms relative to the participant\'s own baseline symptom profile which in turn enables health care providers to rapidly implement modified treatment plans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with COPD undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant has read, understood, and signed a CLN0020 informed consent form prior to enrollment.\n2. Participant is appropriate for Coil treatment per the Conformité Européene (European Conformity \\[CE\\])-Mark Approved RePneu Instructions for Use (IFU).\n3. Participant has been enrolled in and scheduled for treatment(s) with the PneumRx Endobronchial Coil procedure in the CLN0014 study.\n4. Participant's PneumRx Endobronchial Coil procedure is scheduled to occur no fewer than 14 days from enrollment, providing enough time to establish a baseline of their daily symptoms. Ten days minimum of baseline data are required, which is defined as the Run-in period going forward.\n5. Participant is willing and able to use a smart phone.\n\nExclusion Criteria:\n\n1. Participant has undergone a Coil procedure.\n2. Participant has had an acute exacerbation of COPD that required hospitalization or emergency room visit or treatment with systemic steroids and/or antibiotics during the 28 days prior to CLN0020 enrollment.\n3. Participant has a COPD exacerbation or respiratory illness during the Run-in period that in the judgment of the investigator requires medical intervention (for example, treatment with systemic steroids and/or antibiotics and/or hospitalization).\n4. Participant is suffering from terminal illness expected to adversely affect survival in the next 12 months.\n5. Participant has a history of non-compliance with medical therapies."}, 'identificationModule': {'nctId': 'NCT03267992', 'acronym': 'Co-Pilot Air', 'briefTitle': 'Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Observational Study of HGE Health Care Solution COPD Co-Pilot AIR™ Application in Subjects Undergoing the PneumRx® Endobronchial Coil Procedure as Part of EU Registry CLN0014', 'orgStudyIdInfo': {'id': 'CLN0020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'COPD Co-Pilot AIR App', 'type': 'BEHAVIORAL', 'description': 'App. For COPD symptoms after Coil procedure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires de Genève (HUG) Service', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitätsSpital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Daniel Franzen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Pneumologie, Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PneumRx, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}