Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-04 @ 12:08 AM
Study NCT ID:
NCT03845257
Status:
TERMINATED
Last Update Posted:
2022-07-07
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D000089142', 'term': 'Fractional Exhaled Nitric Oxide Testing'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001944', 'term': 'Breath Tests'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'difficult patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-04', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of eosinophilic inflammation by correlating tissue eosinophilia with eosinophil count in blood/BAL and FeNO measurement.', 'timeFrame': '18 months', 'description': 'Correlation of FeNO, blood eosinophils, bronchoalveolar lavage findings and bronchial epithelium histopathology in patients with chronic obstructive pulmonary disease and asthma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Lung Diseases']}, 'descriptionModule': {'briefSummary': 'Scientific research focuses on "eosinophilic inflammation" as it seems to guide the therapeutic regimen in patients with asthma and COPD. The primary objective of this prospective trial is to evaluate which parameter(s) best reflects eosinophilic inflammation by correlating tissue eosinophils (endobronchial biopsy, protected specimen brush sampling) with FeNO, peripheral blood eosinophils, and eosinophils in the bronchoalveolar lavage of patients with obstructive pulmonary disease.', 'detailedDescription': 'This is a multicenter prospective trial. Enrollment will continue until 150 patients with chronic obstructive pulmonary disease and 50 patients with severe asthma have been entered into this trial and have completed bronchoscopic evaluation. In this trial, the following parameters are to be evaluated:\n\n* Blood eosinophils (absolute and relative)\n* FeNO\n* Eosinophils in bronchoalveolar lavage\n* Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosis of COPD or asthma (according to the guidelines)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of COPD or asthma (according to the guidelines)\n* Age \\>18 years\n* Indication for bronchoscopy for medical reasons (not study-related)\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* paO2 \\<60 mmHg on 4L 02 /min, paCO2 \\> 55 mmHg on room air\n* FEV1 \\<20%\n* Pulmonary infection or exacerbation within the last 4 weeks\n* Additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung disease)\n* Contraindication for BAL, PSB sampling or endobronchial biopsy\n* Current use of anticoagulants that can not be stopped for bronchoscopy\n* Heart failure with left ventricular ejection fraction \\<30%\n* Myocardial infarction in previous 6 months\n* Significant pulmonary hypertension (PAPS \\>45 mmHg, right heart failure \\[echocardiography\\] and/or PAPm \\>35 mmHg \\[right heart catheter\\])'}, 'identificationModule': {'nctId': 'NCT03845257', 'briefTitle': 'Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma', 'orgStudyIdInfo': {'id': 'Protocol DG3.0 - 25.06.2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COPD', 'description': 'The following parameters are to be evaluated:\n\n* Blood eosinophils\n* FeNO\n* Eosinophils in bronchoalveolar lavage\n* Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)', 'interventionNames': ['Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling']}, {'label': 'Patients with asthma', 'description': 'The following parameters are to be evaluated:\n\n* Blood eosinophils\n* FeNO\n* Eosinophils in bronchoalveolar lavage\n* Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)', 'interventionNames': ['Diagnostic Test: Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling']}], 'interventions': [{'name': 'Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood sampling (eosinophil count; eosinophilia is defined as \\>300/µl (or \\>150/µl during oral glucocorticosteroid treatment); FeNO: Measurement of fractional nitric oxide (NO) concentration in exhaled breath; Bronchoscopy: BAL: total leukocyte counts and leukocyte differential counts including eosinophils, PSB sampling: eosinophil count/100 cells, endobrochial biopsy: tissue eosinophil count/100 cells.', 'armGroupLabels': ['Patients with COPD', 'Patients with asthma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Macquarie University Sydney', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Borstel', 'country': 'Germany', 'facility': 'Division of Clinical Infectious Diseases/Research Center Borstel', 'geoPoint': {'lat': 52.67034, 'lon': 8.96896}}, {'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik University Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Daniela Gompelmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thoraxklinik University Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Daniela Gompelmann, MD', 'investigatorFullName': 'Daniela Gompelmann', 'investigatorAffiliation': 'Heidelberg University'}}}}