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NCT Number: NCT07275359

Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, 27705, United States

Location contact

Christopher Mosher, MD

PRINCIPAL_INVESTIGATOR

Jessica Shier

CONTACT

[email protected]

919-684-9139

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

All enrolled participants will receive open-label Metformin for a treatment period of 6 months.

Primary outcomes

  1. Determine feasibility of metformin administration in older persons with COPD without diabetes

    Time frame: 6 months

    Enroll and retain ≥ 30 (66%) participants through 6 months study period

  2. Determine acceptability of metformin administration in older persons with COPD without diabetes

    Time frame: 6 months

    ≥70% completion of daily symptom diaries & weekly adherence logs

  3. Determine safety of metformin administration in older persons with COPD without diabetes

    Time frame: 6 months

    ≥90% of the blood glucose levels, renal and hepatic function will be within normal limits*; All lactate levels will be normal

  4. Determine tolerability of metformin administration in older persons with COPD without diabetes

    Time frame: 6 months

    Adverse events and Serious adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Mosher, MD

CONTACT

[email protected]

(919) 684-8111

Jessica Shier

CONTACT

[email protected]

(919) 684-9139

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: INSPIRE-COPD-E

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 10, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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