Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT01592656
Status:
TERMINATED
Last Update Posted:
2014-01-16
First Post:
2012-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'whyStopped': 'Lack of budget', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-15', 'studyFirstSubmitDate': '2012-05-03', 'studyFirstSubmitQcDate': '2012-05-04', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the distribution of the mass flow per lobe and the relative proportion of bloodvessels, as obtained from functional respiratory imaging (FRI) and arterial blood gas (ABG).', 'timeFrame': 'At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV)', 'description': 'The primary objective of this study is the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for V/Q matching) with FRI and ABG values in hypercapnic COPD patients treated with long-term NIV.'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'At baseline, after 1 month and after 6 months', 'description': "Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire"}, {'measure': 'Lung function tests', 'timeFrame': 'At baseline, after 1 month and after 6 months', 'description': 'Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)'}, {'measure': 'Hospital admissions', 'timeFrame': 'After 1 month and after 6 months', 'description': 'Length and frequency of admission, severity of exacerbations, ICU admissions'}, {'measure': 'Exercise tolerance', 'timeFrame': 'At baseline, after 1 month and after 6 months', 'description': '6 minutes walking test and oximetry measurement'}, {'measure': 'Local airway volume and resistance', 'timeFrame': 'At baseline, after 1 month and after 6 months', 'description': 'CT-scan of thorax. CT scan is performed with a low radiation protocol. These images are made to perform computational fluid dynamics on in order to obtain more information on regional lung function characteristics.'}, {'measure': 'Prediction of breathing pattern', 'timeFrame': 'At baseline', 'description': 'The tertiary objective of the study is to predict the breathing pattern (including tidal volume) during NIV when using the data of patient specific lobar compliance and regional resistance at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'GOLD stages II, III and IV', 'Computed Tomography scan', 'Functional Respiratory Imaging', 'Non-Invasive Ventilation', 'Arterial Blood Gas', 'Hypercapnic', 'Health Related Quality of Life', 'Lung compliance'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'In this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q) matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan will be used for FRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥ 40 years old\n* Men and women\n* Written informed consent obtained\n* COPD patients GOLD II, III and IV\n* Persisting hypercapnia (pCO2 \\> 45 mmHg ) notwithstanding adequate treatment modalities (including oxygen) as proposed by the GOLD guidelines\n* Stopped smoking\n* Total lung capacity (TLC) \\> 85%\n\nExclusion Criteria:\n\n* Treatment with home NIV or Continuous Positive Airway Pressure (CPAP)\n* Asthma\n* Restrictive lung disease\n* Symptomatic or uncontrolled heart failure\n* Current malignancy\n* Suspected bad compliance for NIV treatment\n* Pregnant women\n* Not be able to speak the language of the participating center\n* Received an investigational product within 4 weeks prior to inclusion in the study'}, 'identificationModule': {'nctId': 'NCT01592656', 'briefTitle': 'Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'FLUIDDA nv'}, 'officialTitle': 'Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.', 'orgStudyIdInfo': {'id': 'FLUI-2010-68'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-invasive ventilation (NIV)', 'description': '30 patients will receive NIV during 6 months = group 1', 'interventionNames': ['Radiation: Functional Respiratory Imaging', 'Other: Lung compliance measurement', 'Device: Non-invasive ventilation (Respironics)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '10 patients will act as control group, they will not be treated with NIV = group 2', 'interventionNames': ['Radiation: Functional Respiratory Imaging', 'Other: Lung compliance measurement']}], 'interventions': [{'name': 'Functional Respiratory Imaging', 'type': 'RADIATION', 'description': 'CT-scan of thorax. At baseline, after 1 month and after 6 months.', 'armGroupLabels': ['Control group', 'Non-invasive ventilation (NIV)']}, {'name': 'Lung compliance measurement', 'type': 'OTHER', 'description': 'At baseline', 'armGroupLabels': ['Control group', 'Non-invasive ventilation (NIV)']}, {'name': 'Non-invasive ventilation (Respironics)', 'type': 'DEVICE', 'otherNames': ['Trilogy device (Respironics)'], 'description': 'Long-term non-invasive ventilation, starting at baseline until 6 months. At baseline the patients should have persisting hypercapnia (pCO2 \\> 45 mmHg) under optimal conservative treatment other than NIV. The patients can be hospitalised or being treated at home at inclusion.', 'armGroupLabels': ['Non-invasive ventilation (NIV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9700', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Wilfried De Backer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}, {'name': 'Peter Wijkstra, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FLUIDDA nv', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}