Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 7:01 PM
Study NCT ID:
NCT02230020
Status:
TERMINATED
Last Update Posted:
2017-08-08
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of High Flow Therapy in COPD At Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'CRP Fibrinogen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sponsor funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-07', 'studyFirstSubmitDate': '2014-08-29', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Function', 'timeFrame': 'Baseline and 1 month', 'description': 'Spirometry will be performed before and after each sleep study'}, {'measure': 'Dyspnea score', 'timeFrame': 'Baseline and 1 month', 'description': 'Borg scale score before and after each sleep study'}, {'measure': 'Sleep quality', 'timeFrame': 'Baseline and 1 month', 'description': 'Sleep architecture assessed from sleep studies'}, {'measure': 'Quality of life', 'timeFrame': 'Baseline and 1 month', 'description': 'St Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand during sleep. The central hypothesis of this proposal is that lowering ventilatory demand using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic Obstructive Pulmonary Disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Consenting adults over the age of 18 with COPD\n\nExclusion Criteria:\n\n* 1\\. Apnea Hypopnea Index\\>15 events/hr 2. Use of Non-invasive positive pressure ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth breathing at rest) 4. Documented clinical cardiovascular disease, as defined below:\n\n 1. myocardial infarction in past 3 months\n 2. revascularization procedure in past 3 months\n 3. implanted cardiac pacemaker or ICD\n 4. unstable arrhythmias\n 5. congestive heart failure with ejection fraction \\< 40%\n 6. uncontrolled hypertension (BP \\> 190/110) 5. History of end stage renal disease (on dialysis) 6. History of end stage liver disease, such as:\n\n <!-- -->\n\n 1. Jaundice\n 2. ascites\n 3. history of recurrent gastrointestinal bleeding\n 4. transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin. 10. Do you take medications for any of the following reasons:\n\n <!-- -->\n\n 1. Pain control (besides NSAIDs)\n 2. Sleep medication\n 3. Benzodiazepines\n 4. Methadone'}, 'identificationModule': {'nctId': 'NCT02230020', 'acronym': 'EHFT', 'briefTitle': 'Efficacy of High Flow Therapy in COPD At Home', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Efficacy of High Flow Therapy in COPD At Home', 'orgStudyIdInfo': {'id': 'NA_00084508'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nasal High Flow', 'description': 'All subjects are in this group', 'interventionNames': ['Device: Nasal High Flow']}], 'interventions': [{'name': 'Nasal High Flow', 'type': 'DEVICE', 'armGroupLabels': ['Nasal High Flow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jason Kirkness, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}