Exploring the Anti-ageing Effects of Metformin in COPD

Обзор

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.

Вмешательства

• Препарат Metformin 850Mg Tab
  Tolerance phase dose: 850mg/24h for 2 weeks. Treatment dose: 1700 mg twice daily.
• Другое Placebo
  Tolerance phase dose: One tablet/24h for 2 weeks. Treatment dose: Two tablets twice daily.

Первичные конечные точки

• Forced expiratory volume in the first second (FEV1) [Срок оценки: At inclusion and at 3-years follow-up]
• Carbon monoxide diffusion test (DLCO) [Срок оценки: At inclusion and at 3-years follow-up]

Вторичные конечные точки (12)

• Age [Срок оценки: Baseline]
• Sex at birth [Срок оценки: Baseline]
• Height [Срок оценки: Baseline]
• Weight [Срок оценки: Baseline and at 1 year, 2 years and 3 years]
• Smoking [Срок оценки: Baseline]
• The percentage of lung volume with emphysema measured on a chest CT scan. [Срок оценки: At inclusion and at 3-years follow-up]
• 6-minute walk distance (6MWT) [Срок оценки: Baseline and at 1 year, 2 years and 3 years]
• Grip strength with dynamometer [Срок оценки: Baseline and at 1 year, 2 years and 3 years]
• BODE Index [Срок оценки: Baseline and month 6, 12, 18, 24, 30 and 36]
• Dyspnoea [Срок оценки: Baseline and at 1 year, 2 years and 3 years]
• Major cardiovascular events [Срок оценки: Month 6, 12, 18, 24, 30 and 36]
• Cancer events [Срок оценки: Month 6, 12, 18, 24, 30 and 36]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 during the study.
• Known active tuberculosis.
• History of intersticial lung or massive pulmonary thromboembolic disease.
• History of bronchiectasis secondary to respiratory diseasesother than COPD (e.g. cystic fibrosis, Kartagener's syndrome, etc.).
• Any clinically significant disease or disorder (e.g. cardiovascular, gastrointestinal, hepatic, renal (GFR < 30 ml/min), neurological, musculoskeletal, endocrine, metabolic, psychiatric, and major physical impairment) that, in the opinion of the investigator, could have placed the patient at risk for participation in the study, could have influenced the study results, or could have affected the patient's ability to participate in the study.
• 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 oedema and/or cardiac arrhythmia.
• History of cancer (within 5 years prior to Visit 1), except non-metastatic skin cancer and non-melanoma.
• Patients who cannot perform spirometry manoeuvres or tolerate plethysmography.
• Contraindications to the use of metformin: allergy to the drug, advanced renal failure (CKD stage 3 and above), patients on dialysis, chronic metabolic or respiratory acidosis or liver cirrhosis.
• Patients with type 2 Diabetes Mellitus with or without previous use of metformin.
• Pregnant women, nursing mothers or women of childbearing age who are not going to use contraceptive methods.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06999343 · AMICO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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