Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD Exacerbation, COPD
Brief summary
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.
Interventions
DRUGMetformin
All enrolled participants will receive open-label Metformin for a treatment period of 6 months.
Sponsors
Duke University
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will receive open-label Metformin
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine feasibility of metformin administration in older persons with COPD without diabetes | 6 months | Enroll and retain ≥ 30 (66%) participants through 6 months study period |
| Determine acceptability of metformin administration in older persons with COPD without diabetes | 6 months | ≥70% completion of daily symptom diaries \& weekly adherence logs |
| Determine safety of metformin administration in older persons with COPD without diabetes | 6 months | ≥90% of the blood glucose levels, renal and hepatic function will be within normal limits\*; All lactate levels will be normal |
| Determine tolerability of metformin administration in older persons with COPD without diabetes | 6 months | Adverse events and Serious adverse events |
Countries
United States
Contacts
CONTACTChristopher Mosher, MD
CONTACTJessica Shier
PRINCIPAL_INVESTIGATORChristopher Mosher, MD
Duke University
Outcome results
None listed