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 range40 Years – 75 Years
SexALL
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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…
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