Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT03522805
Status:
TERMINATED
Last Update Posted:
2020-08-27
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Non-invasive Ventilation in Hypercapnic COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006935', 'term': 'Hypercapnia'}, {'id': 'D007040', 'term': 'Hypoventilation'}], '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': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Failure to accrue subjects. All activity has stopped \\& no analysis will be done on what has been collected.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-24', 'studyFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2018-05-10', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paired difference in morning level of high sensitivity troponin between baseline and NIV nights', 'timeFrame': '1 day', 'description': 'Comparing morning levels of high sensitivity troponin between baseline and NIV nights'}], 'secondaryOutcomes': [{'measure': 'Paired difference in overnight increase in high sensitivity troponin between baseline and NIV night', 'timeFrame': '1 day', 'description': 'Troponin assay: Minimum 0, no maximum, with higher values worse.'}, {'measure': 'Paired difference in sleep quality by Richards-Campbell Sleep Questionnaire between baseline and NIV night', 'timeFrame': '1 day', 'description': 'Questionnaire: 5 questions, 0 to 100 on visual analog scale, with higher scores indicating better sleep. Total score reported as mean of 5 components.'}, {'measure': 'Paired difference in sleep quality by arousal index between baseline and NIV night', 'timeFrame': '1 day', 'description': 'Arousal index: Index reported as events/hour. Minimum 0, no maximum, with higher scores indicating worse sleep.'}, {'measure': 'Paired difference in heart rate variability during sleep between baseline and NIV night', 'timeFrame': '1 day', 'description': 'Comparing difference in heart rate variability during sleep between baseline and NIV night'}, {'measure': 'Paired difference between Morning psychomotor vigilance testing score between baseline and NIV night', 'timeFrame': '1 day', 'description': 'Psychomotor vigilance score: Reported as number of lapses. Minimum 0, no maximum, with higher values worse.'}, {'measure': 'Paired difference in morning exhaled nitric oxide level between baseline and NIV night', 'timeFrame': '1 day', 'description': 'Exhaled nitric oxide assay: Minimum 0, no maximumm with higher values worse.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['copd', 'lung', 'non-invasive ventilation', 'hypercapnia', 'hypoventilation'], 'conditions': ['Copd', 'Chronic Obstructive Pulmonary Disease', 'Hypercapnia', 'Chronic Respiratory Failure', 'Hypoventilation']}, 'descriptionModule': {'briefSummary': "Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition worldwide and is a cause of substantial morbidity and mortality. Unfortunately, few therapies have been shown to improve survival. The importance of systemic effects and co-morbidities in COPD has garnered attention based on the observation that many patients with COPD die from causes other than respiratory failure, including a large proportion from cardiovascular causes. Recently, two high profile randomized trials have shown substantial improvements in morbidity and mortality with use of nocturnal non-invasive ventilation (NIV) in COPD patients with hypercapnia. Although the mechanisms by which NIV improves outcomes remain unclear, the important benefits of NIV might be cardiovascular via a number of mechanisms. In contrast to prior trials of NIV in COPD that did not show substantial benefit, a distinguishing feature of these encouraging recent NIV clinical trials was a prominent reduction of hypercapnia, which might be a maker or mediator of effective therapy. Alternatively, improvements might be best achieved by targeting a different physiological measure. Additional mechanistic data are therefore needed to inform future trials and achieve maximal benefit of NIV. Recent work in cardiovascular biomarkers has identified high-sensitivity troponin to have substantial ability to determine cardiovascular stress in a variety of conditions - even with only small changes. In COPD, a number of observational studies have shown that high-sensitivity troponin increases with worsening disease severity, and that levels increase overnight during sleep. This biomarker therefore presents a promising means to study causal pathways regarding the effect of NIV in patients with COPD. With this background, the investigator's overall goals are: 1) To determine whether the beneficial effect of non-invasive ventilation might be due to a reduction in cardiovascular stress, using established cardiovascular biomarkers, and 2) To define whether a reduction in PaCO2 (or alternative mechanism) is associated with such an effect."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with previously diagnosed severe COPD (FEV1 \\<50% predicted) and daytime hypercapnia (PaCO2 or TcCO2 \\> 45 mmHg)\n\nExclusion Criteria:\n\n* Lung disease besides COPD (e.g., pulmonary fibrosis, bronchiectasis, pulmonary arterial hypertension) other than well controlled asthma\n* Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure\n* Uncontrolled hypertension (SBP \\>160, DBP \\>95)\n* Unwilling or unable to withhold CPAP during polysomnography\n* Presence of tracheostomy\n* Hospitalization within the past 90 days\n* Prior peptic ulcer disease, esophageal varicies, or gastrointestinal bleeding (\\< 5 years)\n* Prior gastric bypass surgery\n* Anticoagulant use (other than aspirin) or bleeding diathesis (only for esophageal catheter placement)\n* Chronic liver disease or end-stage kidney disease\n* Allergy to any of the study medications\n* Regular use of medications known to affect control of breathing (opioids, benzodiazepines, theophylline)\n* Insomnia or circadian rhythm disorder\n* Active illicit substance use or \\>3 oz nightly alcohol use\n* Psychiatric disease, other than controlled depression\n* Pregnancy\n* Prisoners\n* Cognitive impairment, unable to provide consent, or unable to carry out research procedures'}, 'identificationModule': {'nctId': 'NCT03522805', 'briefTitle': 'Impact of Non-invasive Ventilation in Hypercapnic COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Impact of Non-invasive Ventilation on Biomarkers in Hypercapnic COPD', 'orgStudyIdInfo': {'id': '161873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-invasive ventilation', 'description': 'Subjects will undergo a baseline night with standard polysomnography, followed by a treatment night using non-invasive ventilation under polysomnography', 'interventionNames': ['Device: High-intensity non-invasive ventilation']}], 'interventions': [{'name': 'High-intensity non-invasive ventilation', 'type': 'DEVICE', 'description': 'Single night of high-intensity non-invasive ventilation', 'armGroupLabels': ['Non-invasive ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Jeremy E Orr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Jeremy Orr, M.D.', 'investigatorAffiliation': 'University of California, San Diego'}}}}