METFORMIN HYDROCHLORIDE for Chronic obstructive pulmonary disease

Inclusion criteria

• {"criterion_text":"- Sign the informed consent prior to any study-specific procedure."}
• {"criterion_text":"- Male or female, 40 to 75 years of age, inclusive, at the time of selection."}
• {"criterion_text":"- Have a clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2022 with a post-bronchodilator FEV1/FVC <0.7 at screening (Visit 1)."}
• {"criterion_text":"- Have a post-bronchodilator FEV1> 40% ≤70% of the predicted value at screening (Visit 1)."}
• {"criterion_text":"- Having a smoking history of more than 10 pack-years ([number of cigarettes smoked per day x number of years smoked]/20)."}
• {"criterion_text":"- Must have been able to understand and meet the requirements of the study, in the judgment of the Investigator."}
• {"criterion_text":"- Emphysema (centrolobulillar) reported by an expert radiologist."}
• {"criterion_text":"- Have a certified drop in lung function in the last 3 years >40ml/ml per year of FEV1."}
• {"criterion_text":"- Women of childbearing age with negative pregnancy test."}

Exclusion criteria

• {"criterion_text":"- Participation in another clinical trial with any marketed or investigational biologic drug within 4 months prior to screening."}
• {"criterion_text":"- History of cancer (within 5 years prior to Visit 1), except non-metastatic skin cancer and non-melanoma."}
• {"criterion_text":"- Patients who cannot perform spirometry maneuvers or tolerate plethysmography."}
• {"criterion_text":"- Contraindications for the use of metformin: allergy to the drug or excipients of the same or placebo, advanced renal insufficiency (CKD stage 3 and higher), patient on dialysis, chronic metabolic or respiratory acidosis or liver cirrhosis."}
• {"criterion_text":"- Patients with type 2 Diabetes Mellitus with or without previous use of metformin."}
• {"criterion_text":"- Pregnant women, nursing mothers or women of childbearing age who are not going to use contraceptive methods."}
• {"criterion_text":"- Patients taking oral corticosteroids chronically."}
• {"criterion_text":"- History of respiratory tract infection (including upper respiratory tract) and/or pulmonary exacerbation within 6 weeks prior to screening."}
• {"criterion_text":"- Lung resection or lung volume reduction surgery within 12 months prior to screening (Visit 1), or history of lung transplantation or, in the opinion of the investigator, the patient may have required thoracotomy or other lung surgery during the study."}
• {"criterion_text":"- Known active tuberculosis."}
• {"criterion_text":"- History of interstitial lung or massive pulmonary thromboembolic disease."}
• {"criterion_text":"- History of bronchiectasis secondary to respiratory diseases other than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc.)."}
• {"criterion_text":"- Any clinically significant disease or disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal (GFR < 30 ml/min) neurologic, musculoskeletal, endocrine, metabolic, psychiatric, and major physical impairment) that, in the opinion of the investigator, could have placed the patient at risk for study participation, could have influenced the study results, or could have affected the patient's ability to participate in the study."}
• {"criterion_text":"- Recent history (within 12 months prior to screening [Visit 1]) of myocardial infarction, recent history of heart failure (New York Heart Association [NYHA] classes III and IV), pulmonary edema, and/or cardiac arrhythmia."}

Primary endpoints

• {"endpoint_text":"- Change in FEV1 at baseline and 3-year follow-up.","definition_or_measurement_approach":"FEV1 measured by spirometry at baseline and at 3 years of follow-up (post-bronchodilator FEV1/FVC criteria are used at screening)."}

Secondary endpoints

• {"endpoint_text":"- Age","definition_or_measurement_approach":""}
• {"endpoint_text":"- Sex at birth","definition_or_measurement_approach":""}
• {"endpoint_text":"- Height","definition_or_measurement_approach":""}
• {"endpoint_text":"- Baseline weight and annually until the end of follow-up.","definition_or_measurement_approach":"Weight measured at baseline and annually."}
• {"endpoint_text":"- Baseline smoking status.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Blood tests at baseline and annually until the end of follow-up.","definition_or_measurement_approach":"Blood laboratory analyses at baseline and annually."}
• {"endpoint_text":"- Urinalysis with baseline renal function and annually until the end of follow-up.","definition_or_measurement_approach":"Urinalysis including baseline renal function assessment and annually."}
• {"endpoint_text":"- Baseline and 3-year microbiota analysis.","definition_or_measurement_approach":"Microbiota analysis at baseline and at 3 years."}
• {"endpoint_text":"- Percentage of lung volume affected with emphysema at baseline and 3-year follow-up.","definition_or_measurement_approach":"Quantification of emphysema-affected lung volume (imaging) at baseline and 3 years."}
• {"endpoint_text":"- COPD assessment test (CAT), baseline and every 6 months until the end of follow-up.","definition_or_measurement_approach":"CAT questionnaire administered at baseline and every 6 months."}
• {"endpoint_text":"- mMRC scale at baseline and annually until the end of follow-up.","definition_or_measurement_approach":"mMRC dyspnea scale assessed at baseline and annually."}
• {"endpoint_text":"- Number of annual exacerbations, doctor visits, hospitalisations.","definition_or_measurement_approach":"Collection of exacerbation events, healthcare visits and hospitalisations annually."}
• {"endpoint_text":"- BODE index at baseline and annually until the end of follow-up.","definition_or_measurement_approach":"BODE index calculated at baseline and annually."}
• {"endpoint_text":"- 6 minutes walking test (6MWD) at baseline and annually until the end of follow-up.","definition_or_measurement_approach":"6-minute walk distance measured at baseline and annually."}
• {"endpoint_text":"- Hand grip strength of the dominant hand baseline and annually until the end of follow-up.","definition_or_measurement_approach":"Dominant hand grip strength measured at baseline and annually."}
• {"endpoint_text":"- Incidence of lung cancer and other solid tumours throughout follow-up.","definition_or_measurement_approach":"Recording incidence of lung cancer and other solid tumours during follow-up."}
• {"endpoint_text":"- Incidence of myocardial infarction, new angina, stroke, renal failure throughout follow-up.","definition_or_measurement_approach":"Recording incidence of specified cardiovascular and renal events during follow-up."}

Spain

Latest Decision Or Authorization Date

07-05-2026

Number Of Sites

17

Number Of Participants

212

Primary sponsor

Full Name

Fundacion Instituto De Investigacion Sanitaria De Navarra

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain