Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-17 @ 4:36 PM
Study NCT ID:
NCT01848093
Status:
WITHDRAWN
Last Update Posted:
2016-11-15
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mucin Concentration in Sputum From COPD Patients During a Pulmonary Exacerbation
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mucin concentration', 'timeFrame': '2 month', 'description': 'analyzing mucin concentration by western'}], 'secondaryOutcomes': [{'measure': 'mucin stability', 'timeFrame': '2 month', 'description': 'analyzing mucin stability at 37C over 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung', 'airway', 'pulmonary exacerbation', 'mucus'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '14988081', 'type': 'BACKGROUND', 'citation': 'Henke MO, Renner A, Huber RM, Seeds MC, Rubin BK. MUC5AC and MUC5B Mucins Are Decreased in Cystic Fibrosis Airway Secretions. Am J Respir Cell Mol Biol. 2004 Jul;31(1):86-91. doi: 10.1165/rcmb.2003-0345OC. Epub 2004 Feb 26.'}, {'pmid': '21646446', 'type': 'BACKGROUND', 'citation': 'Henke MO, John G, Rheineck C, Chillappagari S, Naehrlich L, Rubin BK. Serine proteases degrade airway mucins in cystic fibrosis. Infect Immun. 2011 Aug;79(8):3438-44. doi: 10.1128/IAI.01252-10. Epub 2011 Jun 6.'}, {'pmid': '17255563', 'type': 'BACKGROUND', 'citation': 'Henke MO, John G, Germann M, Lindemann H, Rubin BK. MUC5AC and MUC5B mucins increase in cystic fibrosis airway secretions during pulmonary exacerbation. Am J Respir Crit Care Med. 2007 Apr 15;175(8):816-21. doi: 10.1164/rccm.200607-1011OC. Epub 2007 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'chronic obstructive pulmonary disease (COPD) is typically associated with mucus hypersecretion in the airways. In health, mucin is the major macromolecular component and is responsible for the protective and clearance properties of the mucus gel. In a recent study the investigators found that mucins are decreased and unstable in the sputum of adult cystic fibrosis (CF) patients.\n\nIn this study the investigators want to investigate the differences on the mucin quantity and quality of airway secretions during pulmonary exacerbation of patients with COPD.', 'detailedDescription': 'We hypothesize that during an exacerbation the mucin amount is increasing.\n\nThe aim of this study is to evaluate the molecular (mucins) and structure properties (mucin-stability) of the airway secretions in COPD related to the severity of the disease.\n\nWe characterize sputum composition of patients with pulmonary exacerbations. Using gel electrophoresis, with specific antibodies we will analyze MUC5AC and MUC5B mucins.\n\nThe significance of these studies is that they will give us novel information about the pathogenesis of chronic inflammatory airway diseases, provide tools for assessing the progression of lung disease, and most critically, will identify novel opportunities and targets for therapeutic intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients Stadium 2-3 during pulmonary exacerbation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* forced expiratory volume at one second (FEV1) \\< 80%\n* sputum production\n* clinical likely hood of exacerbation\n\nExclusion Criteria:\n\n* FEV1 \\> 80% or \\< 30%\n* increased systemic inflammation\n* susceptibility of pneumonia\n* need for antibiotic treatment'}, 'identificationModule': {'nctId': 'NCT01848093', 'acronym': 'mucinCOPDex', 'briefTitle': 'Mucin Concentration in Sputum From COPD Patients During a Pulmonary Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'Philipps University Marburg'}, 'officialTitle': 'Molekularbiologische Eigenschaften Des Sputums während Einer Pulmonalen COPD Exacerbation', 'orgStudyIdInfo': {'id': '160/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD exacerbation', 'description': 'COPD Stadium 2 and 3 during pulmonary exacerbation\n\nsputum collection', 'interventionNames': ['Other: sputum collection']}], 'interventions': [{'name': 'sputum collection', 'type': 'OTHER', 'description': 'collecting of spontaneous sputum from the patient', 'armGroupLabels': ['COPD exacerbation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35043', 'city': 'Marburg', 'country': 'Germany', 'facility': 'pulmonary department, University Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'University Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'overallOfficials': [{'name': 'Markus Henke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Marburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philipps University Marburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}