Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-22 @ 3:48 AM
Study NCT ID:
NCT03850002
Status:
WITHDRAWN
Last Update Posted:
2019-07-25
First Post:
2019-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Clearance Index and Lung Allograft Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI leaving institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lung clearance index (LCI)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)'}], 'secondaryOutcomes': [{'measure': 'Change in slope of acinar airways (Sacin)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)'}, {'measure': 'Change in slope of conducting airways (Scond)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)'}, {'measure': 'Change in forced expiratory volume in 1s (FEV1)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by Spirometry (Geratherm Respiratory GmbH)'}, {'measure': 'Change in forced vital capacity (FVC)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by Spirometry (Geratherm Respiratory GmbH)'}, {'measure': 'Change in forced expiratory flows at 25-75 of vital capacity (FEF25-75)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by Spirometry (Geratherm Respiratory GmbH)'}, {'measure': 'Change in total lung capacity (TLC)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by Bodyplethysmography (Geratherm Respiratory GmbH)'}, {'measure': 'Change in residual volume (RV)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by Bodyplethysmography (Geratherm Respiratory GmbH)'}, {'measure': 'Change in total lung capacity (TLC) / residual volume (RV) ratio', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by Bodyplethysmography (Geratherm Respiratory GmbH)'}, {'measure': 'Change in diffusing capacity for nitric oxide (DLNO)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Single-breath measurements (Jaeger MasterScreenTM PFT system)'}, {'measure': 'Change in diffusing capacity for carbon monoxide oxide (DLCO)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Single-breath measurements (Jaeger MasterScreenTM PFT system)'}, {'measure': 'Change in DLNO/DLCO ratio', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Single-breath measurements (Jaeger MasterScreenTM PFT system)'}, {'measure': 'Change in transfer coefficient for nitric oxide (DLNO/VA)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Single-breath measurements (Jaeger MasterScreenTM PFT system)'}, {'measure': 'Change in transfer coefficient for carbon monoxide (DLCO/VA)', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Single-breath measurements (Jaeger MasterScreenTM PFT system)'}, {'measure': 'Change in computed tomography score', 'timeFrame': 'Change from baseline up to 3 years', 'description': 'Measured by Computed Tomography: Semiquantative score (i.e., Brody Score); Subscores including bronchiectasis, mucus plugging, airway wall thickening, consolidation, mosaic pattern and air trapping). Subscores will be expressed as the percentage of the maximum score on a scale of 0 (no disease) to 100 (maximal lung disease).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplantation', 'Chronic Lung Allograft Dysfunction', 'Rejection Lung Transplant']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to evaluate the ability of the lung clearance index (LCI) to detect early chronic lung allograft failure (CLAD) in adult lung transplant recipients over a period of 3 years.', 'detailedDescription': 'This single center study consists of three parts:\n\n1. Characterisation of the Zurich lung transplant cohort regarding CLAD status and pulmonary function impairment (cross-sectional, study part I)\n2. Evaluation of test-retest reliability of LCI in 20 clinically stable lung transplant recipients during three consecutive study visits (study part II)\n3. Prospective cohort study to test the ability of LCI to detect early CLAD in patients without prior CLAD (study part III)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult lung transplant patients from University Hospital Zurich will be invited to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female lung transplant recipients\n* Written informed consent by the participant after information about the research project\n\nExclusion Criteria:\n\n* Any contraindication to perform pulmonary function tests (e.g., persistent pneumothorax)\n* Acute airway infection\n* Chronic infection due to Burkholderia spp and nontuberculosis mykobacteria NTM'}, 'identificationModule': {'nctId': 'NCT03850002', 'briefTitle': 'Lung Clearance Index and Lung Allograft Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Lung Clearance Index for the Early Detection and Monitoring of Lung Allograft Dysfunction After Adult Lung Transplantation', 'orgStudyIdInfo': {'id': '2018-02174'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Early detection of CLAD by Lung Clearance Index (LCI)', 'type': 'OTHER', 'description': 'Lung transplant candidates without prior CLAD (evaluated in study part I) will be followed over a period of 3 years to evaluate the potential of LCI to detect early CLAD'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christian Benden, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Zurich, Zurich, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}