Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
NCT ID: NCT07275359
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
45 participants
INTERVENTIONAL
2026-03-01
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Metformin
Metformin in COPD patients without diabetes
Metformin
All enrolled participants will receive open-label Metformin for a treatment period of 6 months.
Interventions
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Metformin
All enrolled participants will receive open-label Metformin for a treatment period of 6 months.
Eligibility Criteria
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Inclusion Criteria
* History of COPD defined by spirometry demonstrating FEV1/FVC \< 70%
* 10 or more tobacco pack year history
* 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
Exclusion Criteria
* Metformin allergy
* History of lactic acidosis not explained by acute, severe illness
* History of low vitamin B12 levels and unwilling to begin standard of care treatment for low vitamin B12 levels
* 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))
* Renal impairment defined as eGFR \< 60 mL/min/1.73m2
* Cognitive impairment
* Dementia
* Heart failure with reduced ejection fraction \< 50%
* Alcohol use disorder
* Disability preventing in-person visits
* 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
* Active treatment with Carbonic Anhydrase Inhibitors including but not limited to topiramate, zonisamide, acetazolamide, diclofenamide
65 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Christopher Mosher, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00116416
Identifier Type: -
Identifier Source: org_study_id
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