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A Study of Metformin for Slowing Down Aging Effects in Patients with Chronic Obstructive Pulmonary Disease

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What is this study about?

This clinical trial is studying Chronic Obstructive Pulmonary Disease, which is a long-term lung condition that makes it difficult to breathe and is often caused by smoking. The study will test whether metformin, a medicine commonly used to treat diabetes, might help slow down lung function decline in people with this breathing disease. Participants will receive either metformin or placebo during the study period.

The purpose of this study is to compare how lung function changes over three years in patients taking metformin compared to those taking placebo. The study will measure lung function using a breathing test that checks how much air a person can force out of their lungs in one second. Participants will need to have a specific type of lung damage called emphysema, which is a form of lung tissue damage that can be seen on imaging scans. They must also have experienced a certain level of decline in their lung function over the past few years.

The study will last for three years, during which participants will take the assigned medication daily. Throughout this time, various measurements will be taken at regular intervals, including breathing tests, blood and urine samples, questionnaires about breathing difficulties and quality of life, and walking tests. Participants will be monitored for any changes in their lung condition, including worsening episodes of breathing problems, doctor visits, and hospital stays. The study will also track the development of other health conditions that might occur during the follow-up period.

1 Initial assessment and baseline measurements

At the beginning of the study, a series of baseline measurements will be taken to establish your starting point.

A breathing test called spirometry will be performed after receiving a medication that opens your airways. This test measures FEV1, which is the amount of air you can forcefully exhale in one second, and FVC, which is the total amount of air you can exhale. These measurements help assess your lung function.

A chest scan will be taken to evaluate the percentage of lung volume affected by emphysema, which is damage to the air sacs in your lungs.

Your age, sex at birth, height, and weight will be recorded.

Information about your smoking history will be collected.

Blood samples will be taken for laboratory analysis.

A urine sample will be collected to assess your kidney function.

A sample will be collected for microbiota analysis, which examines the bacteria living in your body.

You will complete the COPD Assessment Test, a questionnaire that evaluates how your lung condition affects your daily life.

You will complete the mMRC scale, which measures your level of breathlessness during different activities.

You will complete the St. George’s Respiratory Questionnaire, which assesses how your breathing problems impact your quality of life.

Information about any respiratory medications you are currently taking will be recorded.

The BODE index will be calculated, which combines body mass, airflow obstruction, breathlessness, and exercise capacity to predict outcomes.

A 6-minute walking test will be performed, where you will walk as far as you can in 6 minutes to measure your exercise capacity.

Your hand grip strength will be measured using your dominant hand.

2 Treatment phase begins

You will be assigned to receive either metformin or a placebo. A placebo is an inactive substance that looks identical to the medication but contains no active ingredients.

If assigned to metformin, you will receive Metformina Uxa 850 mg tablets. These are film-coated tablets taken by mouth.

If assigned to placebo, you will receive tablets that look identical to metformin but contain only inactive ingredients such as microcrystalline cellulose.

The tablets are packaged in blister packs.

You will take the assigned treatment regularly as instructed throughout the study period.

3 Six-month follow-up visits

Every 6 months throughout the study, you will attend follow-up visits.

At these visits, you will complete the COPD Assessment Test to monitor how your lung condition is affecting your daily activities.

You will also complete the St. George’s Respiratory Questionnaire to assess changes in your quality of life.

Information about any respiratory medications you are taking will be updated.

The number of times your symptoms have worsened significantly, any doctor visits, and any hospital admissions will be recorded.

4 Annual follow-up visits

Once a year throughout the study, you will attend more comprehensive follow-up visits.

Your weight will be measured.

Blood samples will be taken for laboratory analysis.

A urine sample will be collected to check your kidney function.

You will complete the mMRC scale to assess your breathlessness.

The BODE index will be calculated again.

A 6-minute walking test will be performed to measure your exercise capacity.

Your hand grip strength will be measured using your dominant hand.

Throughout the entire follow-up period, any occurrence of lung cancer, other solid tumors, heart attack, new chest pain related to the heart, stroke, or kidney failure will be monitored and recorded.

5 Three-year assessment

At the 3-year mark, additional assessments will be performed.

A breathing test called spirometry will be performed after receiving a medication that opens your airways to measure your FEV1. This will be compared to your baseline measurement to evaluate any changes in lung function.

A chest scan will be taken to assess the percentage of lung volume affected by emphysema and compare it to your baseline scan.

A sample will be collected for microbiota analysis to examine any changes in the bacteria living in your body compared to baseline.

6 Continuation of treatment and monitoring

You will continue taking your assigned treatment and attending regular follow-up visits as described.

The study is expected to continue until May 2029.

Throughout the study, you will continue to receive the same treatment you were initially assigned, and all scheduled assessments will be performed as outlined.

Who Can Join the Study?

  • You must sign a document agreeing to join the study before any study procedures begin. This document is called informed consent and it explains what will happen during the study.
  • You must be between 40 and 75 years old at the time you join the study. This applies to both men and women.
  • You must have a medical diagnosis of COPD, which stands for Chronic Obstructive Pulmonary Disease, a lung condition that makes breathing difficult. The diagnosis must follow specific guidelines called GOLD 2022.
  • You must have a breathing test result showing a specific measurement. After taking a medicine that opens your airways, called a bronchodilator, the ratio of air you can breathe out in one second compared to the total air you can breathe out must be less than 0.7. This test is called FEV1/FVC.
  • You must have another breathing test result showing that the amount of air you can force out in one second, called FEV1, must be more than 40% but no more than 70% of what is expected for someone your age and size. This test is done after taking the airway-opening medicine.
  • You must have a history of smoking more than 10 pack-years. This means if you multiply the number of cigarette packs you smoked per day by the number of years you smoked, the result must be more than 10.
  • You must be able to understand what the study requires and be able to follow the study instructions, as determined by the doctor running the study, called the Investigator.
  • You must have a type of lung damage called emphysema, which is when air sacs in the lungs are damaged. This must be confirmed by a lung specialist who reviews your imaging scans. The emphysema can be either centrolobulillar or paraseptal type.
  • You must have documentation showing that your lung function has decreased over the last 3 years. Specifically, the FEV1 measurement must have dropped by more than 40 milliliters per year.
  • If you are a woman who can become pregnant, you must have a negative pregnancy test, meaning you are not pregnant at the time of joining the study.

Who Cannot Join the Study?

  • No exclusion criteria have been specified for this clinical trial in the provided information.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Hospital Son Llatzer Palma Spain
Servei De Salut De Les Illes Balears Palma Spain
Hospital San Pedro De Alcantara Caceres Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hysdhfds Dr Ln Sgxpb Czfq I Sgzm Prc Barcelona Spain
Hntqhvfm Umxuqgysiooro Di La Pfmqxhli Madrid Spain
Haofnarx Ugczragblanbn Msoausw Da Vangxccfyx Santander Spain
Fkmzuuvgv Pvyk Le Ipcaxvfoexbpe Bxpzoddab Dgt Htjvhhix Ueatkwdbzvevc Ly Pgq Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.09.2025

Trial locations

Investigated drugs:

Metformin is a medication commonly used to treat type 2 diabetes by helping to control blood sugar levels. In this trial, it is being studied to see if it might have anti-aging effects that could help people with COPD (a lung disease). The researchers want to find out if metformin can help improve lung function over time compared to a placebo.

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes it difficult to breathe. The disease develops when the airways and air sacs in the lungs become damaged, usually from long-term exposure to irritating gases or particles, most often from cigarette smoke. As the disease progresses, the airways become inflamed and narrowed, and the air sacs lose their ability to stretch and contract properly. People with this condition experience symptoms such as persistent cough, increased mucus production, wheezing, and shortness of breath that worsens over time. The disease typically develops slowly over many years and gradually interferes with daily activities as breathing becomes more difficult. Physical capacity decreases as the condition advances, making even simple tasks like walking or climbing stairs increasingly challenging.

Trial ID:
2025-520972-24-00
NCT ID:
NCT06999343
Trial Phase:
Therapeutic confirmatory (Phase III)

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