Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-06 @ 9:35 PM
Study NCT ID:
NCT00966459
Status:
COMPLETED
Last Update Posted:
2009-09-01
First Post:
2009-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in 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'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-31', 'studyFirstSubmitDate': '2009-08-26', 'studyFirstSubmitQcDate': '2009-08-26', 'lastUpdatePostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain patient specific geometries of the central and peripheral small airways'}, {'measure': 'To obtain patient specific boundary conditions'}], 'secondaryOutcomes': [{'measure': 'To measure the resistance of the peripheral airways'}, {'measure': 'To measure the reaction of the airways on various inhalation medications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'In this study, 20 COPD patients will undergo a high-resolution/multi slice CT scan and lung function tests to obtain patient specific geometries of the central and peripheral small airways and patient specific boundary conditions.\n\nWith Computational Fluid Dynamics (CFD), the investigators will be able to reconstruct the geometry and measure the resistance of the peripheral airways.\n\nIn a later stage, CFD will be used to simulate the reaction of the airways on various inhalation medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with documented COPD based on the following criteria:\n\n * Smoking history of at least 10 pack-years.\n * Decreased Tiffeneau index (FEV1/(F)VC \\< 0.70).\n2. Patients aged ≥ 40 years.\n3. Patients should present moderate to very severe COPD with an FEV1 \\< 80% of predicted (GOLD 2, 3 and 4).\n4. Patients should be treated according to GOLD guidelines.\n5. Maintained on stable respiratory medications for 4 weeks prior to visit 1\n6. Able to perform lung function tests.\n\nExclusion Criteria:\n\n1. Patients below the age of 40.\n2. Patients who are pregnant or are breast-feeding.\n3. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.\n4. BMI \\> 35 kg/m².\n5. Patients treated with BiPAP or CPAP.\n6. Known active tuberculosis.\n7. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.\n8. A history of thoracotomy with pulmonary resection.\n9. Active or untreated malignancy.'}, 'identificationModule': {'nctId': 'NCT00966459', 'briefTitle': 'Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in COPD Patients', 'orgStudyIdInfo': {'id': 'PML_DOC_0803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'interventionNames': ['Procedure: Computed Tomography']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'PROCEDURE', 'description': '1 low-dose CT is taken', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Dr Wilfried De Backer', 'oldOrganization': 'University Hospital Antwerp, Department of Respiratory Medicine'}}}}