Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT02627833
Status:
UNKNOWN
Last Update Posted:
2015-12-11
First Post:
2015-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cells of induced Sputum, blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'lastUpdateSubmitDate': '2015-12-09', 'studyFirstSubmitDate': '2015-12-09', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lung clearance index (LCI)', 'timeFrame': 'single day observation', 'description': 'Determine Lung clearance index with the Oxygen washout method'}, {'measure': 'FVC [%-pred.]', 'timeFrame': 'single day observation', 'description': 'Compare FVC \\[%-pred.\\] of BO Patients with a healthy control group'}, {'measure': 'FEV1 [%-pred.]', 'timeFrame': 'single day observation', 'description': 'Compare FEV1\\[%-pred.\\] of BO Patients with a healthy control group'}, {'measure': 'Tiffeneau Index', 'timeFrame': 'single day observation', 'description': 'Compare Tiffeneau-Index of BO Patients with a healthy control group'}, {'measure': 'sRtot [%-pred.]', 'timeFrame': 'single day observation', 'description': 'Compare sRtot\\[%-pred.\\] of BO Patients with a healthy control group'}, {'measure': 'RV/TLC [%-pred.]', 'timeFrame': 'single day observation', 'description': 'Compare RV/TLC\\[%-pred.\\] of BO Patients with a healthy control group'}, {'measure': 'DLCO [%-pred.]', 'timeFrame': 'single day observation', 'description': 'Compare difffusion capacity of the lung for CO \\[%-pred.\\] of BO Patients with a healthy control group'}, {'measure': 'IL-6 (pg/ml)', 'timeFrame': 'single day observation', 'description': 'Comparing IL-6 in Serum of patients with BO with a healthy control group'}, {'measure': 'IL-8 (pg/ml', 'timeFrame': 'single day observation', 'description': 'Comparing IL-8 in Serum of patients with BO with a healthy control group'}, {'measure': 'Il-17 (pg/ml)', 'timeFrame': 'single day observation', 'description': 'Comparing IL-17 in Serum of patients with BO with a healthy control group'}, {'measure': 'CrP (mg/dl)', 'timeFrame': 'single day observation', 'description': 'Comparing CrP in Serum of patients with BO with a healthy control group'}, {'measure': 'FeNO ppb', 'timeFrame': 'single day observation', 'description': 'Comparing FeNO in exhaled air of patients with BO with a healthy control group'}, {'measure': 'Sputum cell count', 'timeFrame': 'single day observation', 'description': 'Comparing sputum cell counts of patients with BO with a healthy control group'}], 'primaryOutcomes': [{'measure': 'miRNA Status', 'timeFrame': 'single day observation', 'description': 'Blood sample to determine candidate miRNA for Bronchiolitis obliterans'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['induced Sputum', 'lung clearance index', 'miRNA', 'inflammation', 'chronic lung disease'], 'conditions': ['Bronchiolitis Obliterans']}, 'referencesModule': {'references': [{'pmid': '15635614', 'type': 'BACKGROUND', 'citation': 'Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. doi: 10.1002/ppul.20145.'}, {'pmid': '9824023', 'type': 'BACKGROUND', 'citation': 'Boehler A, Kesten S, Weder W, Speich R. Bronchiolitis obliterans after lung transplantation: a review. Chest. 1998 Nov;114(5):1411-26. doi: 10.1378/chest.114.5.1411. No abstract available.'}, {'pmid': '18475095', 'type': 'BACKGROUND', 'citation': 'Moonnumakal SP, Fan LL. Bronchiolitis obliterans in children. Curr Opin Pediatr. 2008 Jun;20(3):272-8. doi: 10.1097/MOP.0b013e3282ff62e9.'}, {'pmid': '11596161', 'type': 'RESULT', 'citation': 'Pichler M, Herrmann G, Schmidt H, Ahrens P, Zielen S. Persistent adenoviral infection and chronic obstructive bronchitis in children: is there a link? Pediatr Pulmonol. 2001 Nov;32(5):367-71. doi: 10.1002/ppul.1145.'}, {'pmid': '25748838', 'type': 'RESULT', 'citation': 'Rosewich M, Zissler UM, Kheiri T, Voss S, Eickmeier O, Schulze J, Herrmann E, Ducker RP, Schubert R, Zielen S. Airway inflammation in children and adolescents with bronchiolitis obliterans. Cytokine. 2015 May;73(1):156-62. doi: 10.1016/j.cyto.2014.10.026. Epub 2015 Mar 6.'}, {'pmid': '24710011', 'type': 'RESULT', 'citation': 'Motameny S, Wolters S, Nurnberg P, Schumacher B. Next Generation Sequencing of miRNAs - Strategies, Resources and Methods. Genes (Basel). 2010 Jun 3;1(1):70-84. doi: 10.3390/genes1010070.'}]}, 'descriptionModule': {'briefSummary': 'Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process leads to obliteration of the small airways. Pulmonary function tests (body plethysmography with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is measured. A blood test is following to determine the inflammatory status und collect miRNA. Induced Sputum will be obtained.', 'detailedDescription': 'The purpose of this study is to compare miRNA pattern, lung function values, bronchial inflammation and the Lung clearance index of Patients with Bronchiolitis obliterans aged between 6 up to 30 years of age with a matched control group.\n\nThe sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.\n\nSputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) and by cytometric bead assay (CBA). miRNA samples will be collected, processand compared with the miRNA database at http://www.mirbase.org/\n\nMethods and Work Programme:\n\n* Measurement of nitric oxide in expired air (FeNO)\n* Lung function testing with spirometry and body plethysmography\n* Lung clearance index (LCI)\n* Bronchodilation\n* Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system), miRNA analysis\n* Induced sputum for inflammatory mediators and microbiological investigations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with the assured diagnose of Bronchiolitis Obliterans and controls without this disease.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* age between 6 an 35 years\n* known bronchiolitis obliterans (Group Bronchiolitis)/ no Bronchiolitis Obliterans (Group matched controls)\n* ability to perform lung function tests and inhale correctly\n\nExclusion Criteria:\n\n* \\<6 years of age\n* \\>35 years of age\n* acute systemic or bronchial inflammation\n* other chronic diseases or infection (e.g. HIV, Tbc, malignoma)\n* pregnancy\n* alcohol, drug or illegal drug abuse\n* disability to register the range and consequences of the study\n* actual participation in another study'}, 'identificationModule': {'nctId': 'NCT02627833', 'acronym': 'FRABO-03', 'briefTitle': 'Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans', 'orgStudyIdInfo': {'id': 'MRosewich'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subject Group', 'description': 'Patients suffering from Bronchiolitis Obliterans', 'interventionNames': ['Other: observation']}, {'label': 'Control Group', 'description': 'Age and sex matched control group', 'interventionNames': ['Other: observation']}], 'interventions': [{'name': 'observation', 'type': 'OTHER', 'description': 'Record lung function, Lung clearance index, inflammatory status', 'armGroupLabels': ['Control Group', 'Subject Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Rosewich, MD', 'role': 'CONTACT', 'email': 'Martin.Rosewich@kgu.de', 'phone': '49-69-6301', 'phoneExt': '5381'}, {'name': 'Stefan Zielen, MD, PhD', 'role': 'CONTACT', 'email': 'Stefan.Zielen@kgu.de', 'phone': '49-69-6301', 'phoneExt': '83063'}, {'name': 'Martin Rosewich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stefan Zielen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's Hospital, Goethe-University", 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'centralContacts': [{'name': 'Martin Rosewich, MD', 'role': 'CONTACT', 'email': 'Martin.rosewich@kgu.de', 'phone': '+49-69-6301', 'phoneExt': '5381'}], 'overallOfficials': [{'name': 'Martin Rosewich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johann Wolfgang Goethe University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. med. Martin Rosewich', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}