Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations

NCT ID: NCT07275359

Last Updated: 2025-12-10

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive open-label Metformin
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

Metformin in COPD patients without diabetes

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 65 and older
* 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

* Diabetes or actively being treated with metformin
* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Central Contacts

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Christopher Mosher, MD

Role: CONTACT

(919) 684-8111

Jessica Shier

Role: CONTACT

(919) 684-9139

Facility Contacts

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Jessica Shier

Role: primary

(919) 684-9139

Other Identifiers

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1K76AG095138-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00116416

Identifier Type: -

Identifier Source: org_study_id

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