Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04531293
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2020-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Pressure Based and Dilution Based Total Lung Capacity Measurements in COPD Patients for Lung Function Diagnostics
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-03', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Total Lung Capacity (TLC) measurement using total-breath method and standard method', 'timeFrame': 'single measurement on day 1', 'description': 'Difference in Total Lung Capacity (TLC) using total-breath method (according to ATS/ERS standard 2017, EasyOne Pro) and TLC using normal dilution method (according to ATS/ERS standard 2005, EasyOne Pro) in relation to TLC using body plethysmography (Vyaire).'}], 'secondaryOutcomes': [{'measure': 'Dependency between primary outcome and COPD disease severity', 'timeFrame': 'single measurement on day 1', 'description': 'Correlation between ( TLC(dilution, total-breath, EasyOne Pro) - TLC(dilution, standard 2005, EasyOne Pro) ) / TLC(body, Vyaire) and FEV1(EasyOne Pro) / FEV1(predicted)'}, {'measure': 'Device comparison using the same method for both devices.', 'timeFrame': 'single measurement on day 1', 'description': 'Total Lung Capacity (TLC) (dilution, standard 2005, EasyOne Pro) / TLC(dilution, standard, Vyaire). Determines accuracy and comparability of both devices in measurement of TLC.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'DLCO', 'spirometry', 'alveolar volume', 'body plethysmography'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '38475751', 'type': 'DERIVED', 'citation': 'Jorres RA, Buess C, Piecyk A, Thompson B, Stanojevic S, Magnussen H. The total-breath method yields higher values of DLCO and TLC than the conventional method. BMC Pulm Med. 2024 Mar 13;24(1):127. doi: 10.1186/s12890-024-02932-y.'}]}, 'descriptionModule': {'briefSummary': 'Total Lung Capacity (TLC) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e. by single breath dilution during a CO diffusing capacity test). The results of the two methods differ, especially in patients with higher grades of COPD. The study investigates an improved analysis for the determination of TLC using the dilution method; this method has been suggested in the new ATS/ERS DLCO (diffusion capacity of lung for carbon monoxide) standard published in 2017. This study is based on approx. 120 participants. So far, there has not been a study using commercially available equipment.\n\nSpirometry, lung volume measurement by body plethysmography and DLCO measurements will be performed on reference device (Masterscreen Body/Diff, Vyaire, USA), Spirometry and DLCO will also be performed on the device under test (EasyOne Pro LAB, ndd Medizintechnik AG, Switzerland) in a crossover design. Both devices are CE marked and FDA approved. The tests performed on both devices are standardized tests performed routinely with patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n3 groups\n\n* Healthy subjects, FEV1/FEV1(pred) \\> 80%\n* COPD GOLD classification 1 or 2, FEV1/FEV1(pred) ≥ 50%\n* COPD GOLD classification 3 or 4, FEV1/FEV1(pred) \\< 50%\n\nExclusion Criteria:\n\n* Smoked during 2 hours prior to measurements\n\nAdditional exclusion criteria for healthy subjects:\n\n* BMI \\> 30\n* Any relevant concomitant diseases (investigators decision)\n* Any relevant concomitant medication (investigators decision)\n* FEV1/FEV1(pred) \\<= 80%'}, 'identificationModule': {'nctId': 'NCT04531293', 'briefTitle': 'Comparing Pressure Based and Dilution Based Total Lung Capacity Measurements in COPD Patients for Lung Function Diagnostics', 'organization': {'class': 'INDUSTRY', 'fullName': 'ndd Medizintechnik AG'}, 'officialTitle': 'Mono-centred, Controlled Cross-over Study Comparing Pressure Based, and Dilution Based Total Lung Capacity Measurements in COPD Patients and Healthy Subjects Using Two Commercially Available Devices for Lung Function Diagnostics', 'orgStudyIdInfo': {'id': 'EOP17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Total-breath method followed by standard method', 'description': 'Total Lung Capacity (TLC) measurement performed on device EasyOne Pro (TM) according to total-breath method followed by TLC measurement performed on device MasterScreen (TM) according to standard method.', 'interventionNames': ['Device: Respiratory Analysis System']}, {'type': 'OTHER', 'label': 'Standard method followed by total breath method', 'description': 'Total Lung Capacity (TLC) measurement performed on device Masterscreen (TM) according to standard method followed by TLC measurement performed on device EasyOne Pro (TM) according to total-breath method.', 'interventionNames': ['Device: Respiratory Analysis System']}], 'interventions': [{'name': 'Respiratory Analysis System', 'type': 'DEVICE', 'otherNames': ['EasyOne Pro (TM) by ndd Medizintechnik AG'], 'description': 'Measurement of total lung capacity using total-breath method', 'armGroupLabels': ['Standard method followed by total breath method', 'Total-breath method followed by standard method']}, {'name': 'Respiratory Analysis System', 'type': 'DEVICE', 'otherNames': ['Masterscreen (TM) by Vyaire'], 'description': 'Measurement of total lung capacity using standard method', 'armGroupLabels': ['Standard method followed by total breath method', 'Total-breath method followed by standard method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'LungenZentrum Hirslanden', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ndd Medizintechnik AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}