Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations (INSPIRE-COPD-E)

Duke University

Status and phase: Begins enrollment this month; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07275359

1K76AG095138-01 (U.S. NIH Grant/Contract)

Pro00116416

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Metformin

Experimental group

Description:

Metformin in COPD patients without diabetes

Treatment:

Drug: Metformin