Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 3:21 AM
Study NCT ID:
NCT02827734
Status:
UNKNOWN
Last Update Posted:
2020-03-24
First Post:
2016-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D012507', 'term': 'Sarcoidosis'}, {'id': 'D014890', 'term': 'Granulomatosis with Polyangiitis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010993', 'term': 'Plethysmography, Whole Body'}], 'ancestors': [{'id': 'D010991', 'term': 'Plethysmography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-07-05', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lung clearance index (LCI) as determined by multiple breath washout', 'timeFrame': '30 minutes'}, {'measure': 'airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'repeatability of lung clearance index (LCI)', 'timeFrame': '30 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pulmonary Healthy Controls', 'Interstitial Lung Disease', 'Idiopathic Pulmonary Fibrosis', 'Non-specific Interstitial Pneumonia', 'Sarcoidosis', "Granulomatosis With Polyangiitis (Wegener's Disease)"]}, 'descriptionModule': {'briefSummary': 'Current diagnostic tools used in interstitial lung disease (ILD) do not meet the challenges set by the complex pathophysiology of this heterogenous group. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of patients with various ILDs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with indication for routine lung function testing', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* known or suspected interstitial lung disease\n\nExclusion Criteria:\n\n* pregnancy\n* inability to participate'}, 'identificationModule': {'nctId': 'NCT02827734', 'briefTitle': 'Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)', 'orgStudyIdInfo': {'id': 'MBW-ILD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'interstitial lung disease', 'description': 'patients with known or suspected ILD such as idiopathic pulmonary fibrosis, non-specific interstitial pneumonia, sarcoidosis, granulomatosis with polyangiitis', 'interventionNames': ['Device: multiple breath washout tests', 'Device: impulse oscillometry', 'Device: body plethysmography']}, {'label': 'pulmonary healthy controls', 'description': 'patients without known or suspected pulmonary disease', 'interventionNames': ['Device: multiple breath washout tests', 'Device: impulse oscillometry', 'Device: body plethysmography']}], 'interventions': [{'name': 'multiple breath washout tests', 'type': 'DEVICE', 'armGroupLabels': ['interstitial lung disease', 'pulmonary healthy controls']}, {'name': 'impulse oscillometry', 'type': 'DEVICE', 'armGroupLabels': ['interstitial lung disease', 'pulmonary healthy controls']}, {'name': 'body plethysmography', 'type': 'DEVICE', 'armGroupLabels': ['interstitial lung disease', 'pulmonary healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'state': 'Deutschland', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Frederik Trinkmann, Dr.', 'role': 'CONTACT', 'email': 'frederik.trinkmann@umm.de', 'phone': '+496213833879'}, {'name': 'Frederik Trinkmann, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joachim Saur, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thomas Henzler, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsmedizin Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Frederik Trinkmann, Dr.', 'role': 'CONTACT', 'email': 'frederik.trinkmann@umm.de', 'phone': '+496213833879'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Frederik Trinkmann', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}