Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT07275359
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07275359
Study Brief:
Protocol Section:
NCT07275359