Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02557958
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2015-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2015-09-02', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory markers', 'timeFrame': 'outcome will be assessed up to two months post initial bronchoscopy', 'description': 'Cytokines in BAL in pg/mL'}], 'secondaryOutcomes': [{'measure': 'transcription factor changes', 'timeFrame': 'outcome will be assessed up to two months post initial bronchoscopy', 'description': 'BAL cell differential in percentage'}, {'measure': 'Lung function changes', 'timeFrame': 'outcome will be assessed up to two months post initial bronchoscopy', 'description': 'Forced Vital Capacity (FVC)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD, pulmonary disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '27486204', 'type': 'DERIVED', 'citation': 'Segal LN, Clemente JC, Wu BG, Wikoff WR, Gao Z, Li Y, Ko JP, Rom WN, Blaser MJ, Weiden MD. Randomised, double-blind, placebo-controlled trial with azithromycin selects for anti-inflammatory microbial metabolites in the emphysematous lung. Thorax. 2017 Jan;72(1):13-22. doi: 10.1136/thoraxjnl-2016-208599. Epub 2016 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.', 'detailedDescription': 'Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of death in the United States. It is projected to be the leading cause of death by 2020. As many as 24 million Americans are estimated to suffer from impaired lung function. Of those more than 12 million were actually diagnosed with COPD, and over 118,000 deaths were attributed to COPD in 2004.\n\nCOPD has been linked with an increased risk for lung cancer. Both airway obstruction, defined by abnormal pulmonary function tests (PFTs), and CT scan diagnosed emphysema were shown to be independent risk factors for lung cancer.\n\nTreatment for COPD includes cessation of environmental exposures (i.e. smoking), dampening the inflammatory response, symptoms control and, for a small subgroup, surgical approaches and lung transplant. Nevertheless, the effectiveness of these treatment options to change the natural history of this disease is very limited. Recent evidence suggests a new role for macrolides as immune-modulators in patients with COPD, although the mechanisms are not clearly determined.\n\nThe investigators hypothesize that in patients with COPD, treatment with azithromycin will show reduced inflammatory markers, transcription factors changes, and lung function changes consistent with reduced inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Key Inclusion Criteria: List primary criteria for study inclusion (i.e. do not need to enter entire list of inclusion criteria).\n\n 1. Patient must be 50 years old or older.\n 2. Patient must have a smoking history of at least 20 pack-years\n 3. Patient must have stable COPD, GOLD 0, I and/or IIA.\n 4. CT of chest with evidence of emphysema\n* Key Exclusion Criteria: List primary criteria for study exclusion (i.e. do not need to enter entire list of inclusion criteria).\n\n 1. FEV1 \\< 70%.\n 2. Exacerbations (defined as use of oral steroids or antibiotics) in the previous month.\n 3. Cardiovascular Disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.\n 4. Diabetes mellitus\n 5. Renal disease\n 6. Liver disease\n 7. Lung cancer\n 8. ETOH use of more than \\>6 beers \\>4 mixed drinks daily'}, 'identificationModule': {'nctId': 'NCT02557958', 'briefTitle': 'Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study', 'orgStudyIdInfo': {'id': '09-0769'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azithromycin', 'description': 'Azithromycin 250mg daily, single daily use for 8 weeks', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo daily for 8 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Zithromax'], 'description': 'We hypothesize that in patients with COPD, treatment with azithromycin will show reduced inflammatory markers, transcription factors changes, and lung function changes consistent with reduced inflammation.', 'armGroupLabels': ['Azithromycin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'We hypothesize that in patients with COPD, treatment with placebo will show NO change in inflammatory markers, transcription factor changes and lung function from baseline.', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}