Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT07275359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive open-label Metformin'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2025-11-28', 'studyFirstSubmitQcDate': '2025-11-28', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine feasibility of metformin administration in older persons with COPD without diabetes', 'timeFrame': '6 months', 'description': 'Enroll and retain ≥ 30 (66%) participants through 6 months study period'}, {'measure': 'Determine acceptability of metformin administration in older persons with COPD without diabetes', 'timeFrame': '6 months', 'description': '≥70% completion of daily symptom diaries \\& weekly adherence logs'}, {'measure': 'Determine safety of metformin administration in older persons with COPD without diabetes', 'timeFrame': '6 months', 'description': '≥90% of the blood glucose levels, renal and hepatic function will be within normal limits\\*; All lactate levels will be normal'}, {'measure': 'Determine tolerability of metformin administration in older persons with COPD without diabetes', 'timeFrame': '6 months', 'description': 'Adverse events and Serious adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD Exacerbation', 'COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and tolerability of Metformin and how it changes blood markers associated with aging in persons who have chronic obstructive pulmonary disease (COPD) who do not have diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 and older\n* History of COPD defined by spirometry demonstrating FEV1/FVC \\< 70%\n* 10 or more tobacco pack year history\n* History of frequent exacerbations defined as: 1 severe (i.e., COPD hospitalization) or 2 moderate (i.e., outpatient treated exacerbations) in the previous 12 months\n\nExclusion Criteria:\n\n* Diabetes or actively being treated with metformin\n* Metformin allergy\n* History of lactic acidosis not explained by acute, severe illness\n* History of low vitamin B12 levels and unwilling to begin standard of care treatment for low vitamin B12 levels\n* Hepatic impairment defined as history of cirrhosis or abnormal liver function tests (e.g., alanine transaminase (ALT): 7-55 units per liter (U/L), aspartate transaminase (AST): 8-48 U/L, alkaline phosphatase (ALP): 40-129 U/L, or bilirubin: 0.1-1.2 milligrams per deciliter (mg/dL))\n* Renal impairment defined as eGFR \\< 60 mL/min/1.73m2\n* Cognitive impairment\n* Dementia\n* Heart failure with reduced ejection fraction \\< 50%\n* Alcohol use disorder\n* Disability preventing in-person visits\n* Persons with an unstable medical condition (including but not limited to unstable angina, acute heart failure exacerbation, acute neurological symptoms) or COPD exacerbation within 30 days prior to enrollment will be excluded\n* Active treatment with Carbonic Anhydrase Inhibitors including but not limited to topiramate, zonisamide, acetazolamide, diclofenamide'}, 'identificationModule': {'nctId': 'NCT07275359', 'acronym': 'INSPIRE-COPD-E', 'briefTitle': 'Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations', 'orgStudyIdInfo': {'id': 'Pro00116416'}, 'secondaryIdInfos': [{'id': '1K76AG095138-01', 'link': 'https://reporter.nih.gov/quickSearch/1K76AG095138-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Metformin in COPD patients without diabetes', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'All enrolled participants will receive open-label Metformin for a treatment period of 6 months.', 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Jessica Shier', 'role': 'CONTACT', 'email': 'jessica.shier@duke.edu', 'phone': '(919) 684-9139'}, {'name': 'Christopher Mosher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke Asthma, Allergy, and Airway Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Christopher Mosher, MD', 'role': 'CONTACT', 'email': 'christopher.mosher@duke.edu', 'phone': '(919) 684-8111'}, {'name': 'Jessica Shier', 'role': 'CONTACT', 'email': 'jessica.shier@duke.edu', 'phone': '(919) 684-9139'}], 'overallOfficials': [{'name': 'Christopher Mosher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}