Chronic Obstructive Pulmonary Disease (COPD)Phase 1INSPIRE-COPD-ENCT07275359
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
A Phase 1 study testing Metformin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 1 Oct 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, 27705
Jessica Shier, (919) 684-9139, jessica.shier@duke.edu
Christopher Mosher, MD
About this study
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.
- Being tested
- Metformin
- Keywords
- COPD Exacerbation, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
All enrolled participants will receive open-label Metformin for a treatment period of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin in COPD patients without diabetes Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine feasibility of metformin administration in older persons with COPD without diabetes
Enroll and retain ≥ 30 (66%) participants through 6 months study period
Measured: 6 months
Determine acceptability of metformin administration in older persons with COPD without diabetes
≥70% completion of daily symptom diaries \& weekly adherence logs
Measured: 6 months
Determine safety of metformin administration in older persons with COPD without diabetes
≥90% of the blood glucose levels, renal and hepatic function will be within normal limits*; All lactate levels will be normal
Measured: 6 months
Determine tolerability of metformin administration in older persons with COPD without diabetes
Adverse events and Serious adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive open-label Metformin
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Christopher Mosher, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275359
- Sponsor's protocol ID
- Pro00116416
- Other IDs
- 1K76AG095138-01
- Acronym
- INSPIRE-COPD-E
- Status last verified
- Nov 2026
- First submitted
- 28 Nov 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
- ClinicalTrials.gov ID
- NCT07275359
- Acronym / sponsor ID
- INSPIRE-COPD-E / Pro00116416
- Keywords
- COPD Exacerbation, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive open-label Metformin
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin in COPD patients without diabetes |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAll enrolled participants will receive open-label Metformin for a treatment period of 6 months. | Drug | Metformin |
Primary outcome
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
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
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
Determine tolerability of metformin administration in older persons with COPD without diabetes
Time frame: 6 months
Adverse events and Serious adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Mosher, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Mosher, MD ((919) 684-8111, christopher.mosher@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine feasibility of metformin administration in older persons with COPD without diabetes (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.