Exploring the Anti-ageing Effects of Metformin in COPD (NCT06999343) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Exploring the Anti-ageing Effects of Metformin in COPD
212 participantsStarted 2025-09-01
Plain-language summary
Prospective, multicentre, double-blind, placebo-controlled, randomised, prospective clinical trial comparing the effect of metformin 850 mg twice daily with placebo in COPD patients with evidence of emphysema (by CT scan or reduced DLCO) who are known to have a rapid decrease in FEV1.
Main objective:
To compare the change in FEV1 at 3 years follow-up in patients receiving metformin versus placebo.
Participants will take metformin (850mg) or placebo twice daily for 3 years.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sign the informed consent form prior to any study-specific procedure.
* Male or female, aged 40 to 75 years, inclusive, at the time of Screening.
* Have a COPD clinic diagnostic according to Global Initiative for Obstructive Lung Disease (GOLD) 2022 with a post-bronchodilator FEV1/FVC \<0.7 at Screening (Visit 1)
* Have a post-bronchodilator FEV1 \>40% ≤ 70% of the predicted value at Screening (Visit 1)
* Smoking history of more than 10 pack/years (\[number of cigarettes smoked per day x number of years smoked\]/20)
* Must have been able to understand and comply with the requirements of the study, as judged by the investigator.
* Have some kind of emphysema (centrolobulillar or paraseptal) reported by an expert radiologist.
* Have a certified decrease of the Lung Function in the last 3 years \>40 ml/ml per year of FEV1.
* Women in childbearing age with negative pregnancy test.
Exclusion Criteria:
* Participating in another clinic trial with any commercially or investigational biological medicinal product within 4 months prior to Screening.
* Patients who take oral corticosteroids chronically.
* Respiratory track infection history (superior respiratory tract included) and pulmonary exarcerbation within 6 weeks prior to Screening.
* Lung resection or lung volume reduction surgery within 12 months prior to Screening (Visit 1), or lung trasplant history, or, as judged by the investigator, patient may have required a thoracotomy or other lung surgery durin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Forced expiratory volume in the first second (FEV1)
Timeframe: At inclusion and at 3-years follow-up
2
Carbon monoxide diffusion test (DLCO)
Timeframe: At inclusion and at 3-years follow-up
Trial details
NCT IDNCT06999343
SponsorFundación Instituto de Investigación Sanitaria de Navarra