Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT04638920
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2020-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'malcolm.kohler@usz.ch', 'phone': '+41442551111', 'title': 'Prof. Malcolm Kohler, Sponsor-Investigator', 'organization': 'University Hospital Zurich'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Serious events were collected during study period between time of inclusion (acute COPD exacerbation) and follow-up visit at stable state approximately 8 weeks after inclusion.', 'description': 'Serious event were defined as follows:\n\nAny unfavorable event where it cannot be excluded that the event is attributable to the sampling of biological material or the collection of health-related personal data, and which:\n\n1. requires inpatient treatment not envisaged in the project plan or extends a current hospital stay;\n2. results in permanent or significant incapacity or disability; or\n3. is life-threatening or results in death.', 'eventGroups': [{'id': 'EG000', 'title': 'Exacerbators', 'description': 'Patients with acute COPD exacerbation under triple inhalation therapy\n\nNo intervention: No intervention', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Exhaled Breath Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exacerbators', 'description': 'Patients with acute exacerbation of COPD under triple exhalation therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '3298', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'twice during 8 weeks', 'description': 'Number of exhaled breath features/metabolites that show a change in intensity (unit of features: mass over charge ratio) during vs after COPD exacerbation. Exhaled breath features are measured via mass spectrometer. Change is calculated as feature intensity during COPD exacerbation minus feature intensity after COPD exacerbation (8 weeks after) for each detected exhaled breath feature.', 'unitOfMeasure': 'breath metabolites', 'reportingStatus': 'POSTED', 'populationDescription': 'Exhaled breath data of two participants were not analazable due to technical problems.'}, {'type': 'SECONDARY', 'title': 'Symptoms', 'timeFrame': 'twice during 8 weeks', 'description': 'Correlation of breath metabolites with symptoms (mMRC and CAT) both measured twice during and after COPD exacerbation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Inflammation', 'timeFrame': 'twice during 8 weeks', 'description': 'Correlation of breath metabolites with CRP, eosinophils, and exhaled NO, all measured twice during and after COPD exacerbation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Causative Agents', 'timeFrame': 'twice during 8 weeks', 'description': 'Correlation of breath metabolites with sputum microbiology and viral swabs, both measured twice during and after COPD exacerbation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Treatment', 'timeFrame': 'measured once during COPD exacerbation', 'description': 'Correlation of breath metabolites with inhalational drugs, steroids, and antibiotics, both measured during COPD exacerbation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exacerbators', 'description': 'Patients with acute exacerbation of COPD under triple exhalation therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Patients were recruited at the University Hospital Zurich between November 2020 and April 2024. Study duration was extended due to lack of sufficient patients until July 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Exacerbators', 'description': 'Patients with acute exacerbation of COPD under triple exhalation therapy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'GOLD ABE classification', 'classes': [{'title': 'Class A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Class B', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Class E', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The classification incorporates patients' symptomatic assessemetn and risk of exacerbation. Class A shows less symptoms and 0 to 1 moderate exacerbation in the previous year. Class B shows high symptoms and 0 to 1 moderate exacerbation in the previous year. Class E shows high symptoms and ≥ 2 moderate exacerbations or ≥ 1 leading to hospitalization.", 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Exacerbation history', 'classes': [{'title': 'Number of acute COPD exacerbations', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.9', 'groupId': 'BG000'}]}]}, {'title': 'Number of severe acute COPD exacerbations', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'acute COPD exacerbation history in the previous year', 'unitOfMeasure': 'events', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Treatment during acute COPD exacerbation', 'classes': [{'title': 'Antibiotics only', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Systemic corticosteroids only', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Antibiotics and systemic corticosteroids', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Data of 28 participants were included in the final analysis as five patients withdrew their participation and the main outcome (breath analysis) of two participants was not analyzable.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-02', 'size': 893603, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-29T09:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2020-11-16', 'resultsFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-15', 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Exhaled Breath Metabolites', 'timeFrame': 'twice during 8 weeks', 'description': 'Number of exhaled breath features/metabolites that show a change in intensity (unit of features: mass over charge ratio) during vs after COPD exacerbation. Exhaled breath features are measured via mass spectrometer. Change is calculated as feature intensity during COPD exacerbation minus feature intensity after COPD exacerbation (8 weeks after) for each detected exhaled breath feature.'}], 'secondaryOutcomes': [{'measure': 'Symptoms', 'timeFrame': 'twice during 8 weeks', 'description': 'Correlation of breath metabolites with symptoms (mMRC and CAT) both measured twice during and after COPD exacerbation'}, {'measure': 'Inflammation', 'timeFrame': 'twice during 8 weeks', 'description': 'Correlation of breath metabolites with CRP, eosinophils, and exhaled NO, all measured twice during and after COPD exacerbation'}, {'measure': 'Causative Agents', 'timeFrame': 'twice during 8 weeks', 'description': 'Correlation of breath metabolites with sputum microbiology and viral swabs, both measured twice during and after COPD exacerbation'}, {'measure': 'Treatment', 'timeFrame': 'measured once during COPD exacerbation', 'description': 'Correlation of breath metabolites with inhalational drugs, steroids, and antibiotics, both measured during COPD exacerbation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exhaled breath analysis', 'Mass spectrometry'], 'conditions': ['COPD Exacerbation']}, 'referencesModule': {'references': [{'pmid': '41013424', 'type': 'DERIVED', 'citation': 'Sievi NA, Schmidt F, Fricke K, Baur DM, Basler S, Herth J, Kohler M. Acute COPD exacerbation despite triple inhaled therapy: a molecular insight - TripleEx study. Respir Res. 2025 Sep 26;26(1):273. doi: 10.1186/s12931-025-03352-0.'}]}, 'descriptionModule': {'briefSummary': 'Determination of specific molecular breath patterns by secondary electrospray ionization mass spectrometry (SESIHRMS) during and 8 weeks after a COPD exacerbation. Furthermore, breath patterns will be assessed for correlation and association with clinical outcomes and treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with COPD (staged according to GOLD recommendations, aged ≥18 years) on adherent triple inhalational therapy, hospitalized due to COPD exacerbation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* age \\>= 18 years\n* staged according to GOLD recommendations\n* GOLD stage 2-4, GOLD ABE classification\n* hospitalization due to COPD exacerbation\n* subjects adherent to triple inhalational therapy (beta-2-sympathomimetics, anticholinergics, steroids)\n* suitable for follow-up assessment\n* \\<48 hours after initiation of antibiotic therapy or systemic steroid therapy\n\nExclusion Criteria:\n\n* physical or intellectual impairment precluding informed consent or protocol adherence\n* known pregnancy\n* congenital defects with direct impact on central metabolism e.g. amino acid metabolism defect\n* uncontrolled diabetes (e.g. HbA1c \\>11% or Glc \\>20mmol/l)\n* acute or chronic pulmonary disease other than COPD\n* renal failure or renal replacement therapy (GFR \\< 15 mL/min)'}, 'identificationModule': {'nctId': 'NCT04638920', 'acronym': 'TripleEX', 'briefTitle': 'Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy (TripleEX)', 'orgStudyIdInfo': {'id': 'BASEC-Nr. 2020-01954'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exacerbators', 'description': 'Patients with acute COPD exacerbation under triple inhalation therapy', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Exacerbators']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malcolm Kohler', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deep Breath Intelligence (DBI)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Malcolm Kohler', 'investigatorAffiliation': 'University of Zurich'}}}}