Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01612793
Status:
TERMINATED
Last Update Posted:
2019-02-28
First Post:
2012-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'clinical@electrocorellc.com', 'phone': '+1 973 355 6683', 'title': 'Clinical Affairs', 'organization': 'electroCore LLC'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal', 'eventGroups': [{'id': 'EG000', 'title': 'AlphaCore Active Device', 'description': 'AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.\n\nAlphaCore Device: multiple stimulation treatments per day for duration of hospitalization', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AlphaCore Sham Device', 'description': 'AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.\n\nAlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Non-ST elevation myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Confusion/ Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute exacerbations of chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Length of Stay in the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AlphaCore Active Device', 'description': 'AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.\n\nAlphaCore Device: multiple stimulation treatments per day for duration of hospitalization'}, {'id': 'OG001', 'title': 'AlphaCore Sham Device', 'description': 'AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.\n\nAlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '11'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal', 'description': 'The primary outcome measure was hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject met the medical elements of the GOLD Discharge Criteria. (Global Initiative for Chronic Obstructive Lung Disease report, "Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease", Revised 2011)', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AlphaCore Active Device', 'description': 'AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.\n\nAlphaCore Device: multiple stimulation treatments per day for duration of hospitalization'}, {'id': 'FG001', 'title': 'AlphaCore Sham Device', 'description': 'AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.\n\nAlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AlphaCore Active Device', 'description': 'AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.\n\nAlphaCore Device: multiple stimulation treatments per day for duration of hospitalization'}, {'id': 'BG001', 'title': 'AlphaCore Sham Device', 'description': 'AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.\n\nAlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '74'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '79'}, {'value': '69', 'groupId': 'BG002', 'lowerLimit': '58', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Complete CBC and blood gases will be drawn at different time points to establish the medical condition of the subjects.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2012-05-25', 'resultsFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2012-06-04', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-25', 'studyFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Length of Stay in the Hospital', 'timeFrame': 'Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal', 'description': 'The primary outcome measure was hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject met the medical elements of the GOLD Discharge Criteria. (Global Initiative for Chronic Obstructive Lung Disease report, "Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease", Revised 2011)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This study will look at the safety, improving symptoms and decreasing the length of stay of patients admitted to the hospital with COPD.', 'detailedDescription': 'The primary safety measurement for this study is the type, occurrence and severity of adverse events (anticipated and unanticipated), including serious and non-serious device-related events.\n\nThe primary outcome measure is hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject meets the medical elements of the GOLD Discharge Criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Potential study subjects will be provided a study information sheet (informed consent form) to review. Those who are interested in participating will provide signed informed consent and then be screened for eligibility (inclusion/exclusion criteria). Subjects meeting the inclusion/exclusion criteria will be assigned a study ID number, randomized and enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is over the age of 35 years\n2. Has a history of COPD confirmed by physician diagnosis\n3. Has been admitted to the hospital with a working diagnosis of acute exacerbation of COPD (AECOPD) defined as at least two of the following progressive symptoms: increased dyspnea, increased sputum volume and/or increased sputum purulence that is beyond normal day-to-day variation\n4. Has a history of incomplete airway reversibility (e.g., patient not responding clinically to short-acting ß-agonists in the ED) associated with a diagnosis of COPD\n5. Smoking history of at least 20 pack years\n6. FEV1/FVC ratio of \\< 0.7 and impaired FEV1 (\\< 80% predicted for age, sex, race and height)\n7. Is willing to participate in a 7 days post discharge (± 2 days) in-person follow-up visit and a telephone follow-up call 30 days (± 5 days) after hospital discharge\n8. Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent\n\nExclusion Criteria:\n\n1. Has a confirmed history of asthma (by pulmonary functions, response to ß-agonists and variable symptoms)\n2. Has a history of lung cancer or Talc lung\n3. Is admitted to the emergency care facility with a diagnosis of the following, confirmed on CXR, ventilation/perfusion scanning or computerized tomography (CT):\n\n * Pulmonary abscess;\n * Pneumonia (e.g., fever \\> 38.0° C, cough and new documented infiltrate)\n * Acute pulmonary embolism\n * Large pleural effusion and/or requiring thoracentesis; or\n * Pneumothorax\n4. Is admitted to the emergency care facility with a working diagnosis of:\n\n * Acute coronary syndrome\n * Severe carotid artery disease (e.g., history of bruits, transient ischemic attack (TIA) or cerebrovascular accident (CVA); or\n * Stage IV heart failure according to the NYHA classification\n5. Is admitted to the emergency care facility and/or hospital with a working diagnosis of:\n\n * Cystic Fibrosis; or\n * Tuberculosis\n * Pneumocystis carinii pneumonia (PCP) infection in the setting of HIV\n6. Other severe cardiovascular acute diseases (such as uncontrolled hypertension, recent onset rapid atrial fibrillation and severe ventricular arrhythmias)\n7. Is at risk of imminent respiratory collapse:\n\n * Lung Function: FEV1 \\< 25%\n * Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc).\n8. Has a condition in which collecting blood would be contraindicated or blood samples are unable to be obtained;\n9. Has an abscess or other infection, lesion (including lymphadenopathy), surgical scar, congenital changes or broken skin at the treatment site on the neck;\n10. Has confirmed severe sepsis or septic shock\n11. Has a fever \\> 38.0° C\n12. Has clinically significant changes in blood pressure or is receiving vasopressors to maintain blood pressure\n13. Has an implanted electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, automated implantable cardioverter defibrillators (AICD), vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant\n14. Has a history of carotid endarterectomy or vascular neck surgery on the right side\n15. Has implanted metal cervical spine hardware\n16. Has a condition that would interfere with completing the self-assessment questionnaires\n17. Is pregnant or breast feeding\n18. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days\n19. Belongs to a population or has any condition such that the investigator believes his or her ability to provide informed consent, comply with follow-up requirements or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner)'}, 'identificationModule': {'nctId': 'NCT01612793', 'briefTitle': 'Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations', 'organization': {'class': 'INDUSTRY', 'fullName': 'ElectroCore INC'}, 'officialTitle': 'Non-Invasive Vagus Nerve Stimulation With the AlphaCore Device for Management of Bronchoconstriction in Patients Hospitalized With COPD', 'orgStudyIdInfo': {'id': 'COPD-CA-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AlphaCore device', 'description': 'AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.', 'interventionNames': ['Device: AlphaCore Device']}], 'interventions': [{'name': 'AlphaCore Device', 'type': 'DEVICE', 'otherNames': ['Non-invasive vagus nerve stimulation'], 'description': 'multiple stimulation treatments per day for duration of hospitalization', 'armGroupLabels': ['AlphaCore device']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G,2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Edmonton Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Brian Rowe, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ElectroCore INC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}