Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-01-02 @ 8:55 AM
Study NCT ID:
NCT01337661
Status:
COMPLETED
Last Update Posted:
2012-08-28
First Post:
2011-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations
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': 'Blood, Endobronchial tissues and Bronchoalveolar (BAL) samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2011-04-13', 'studyFirstSubmitQcDate': '2011-04-15', 'lastUpdatePostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of how inflammatory pathways differ in COPD subjects', 'timeFrame': '6 weeks', 'description': 'Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.'}], 'secondaryOutcomes': [{'measure': 'Biomarker Sample Repository', 'timeFrame': '6 weeks', 'description': 'Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'COPD', 'Acute Exacerbation of COPD', 'AECOPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).', 'detailedDescription': 'This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects referred to the hospital clinic with AECOPD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease\n* Current or ex-smoker with a tobacco history of 15 or more pack years\n* Females of childbearing potential must use birth control for the duration of the study.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant disease\n* Subjects with asthma\n* Subjects taking anti-leukotriene medications'}, 'identificationModule': {'nctId': 'NCT01337661', 'briefTitle': 'A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations', 'orgStudyIdInfo': {'id': 'CD-RI-INDP-1048'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD subjects', 'description': 'Adult male and female subjects with COPD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Rene van der Merwe, MBChB, MFPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune Ltd'}, {'name': 'Prof. Connor Burke', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BCF Diagnostics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}