Exploring the Anti-ageing Effects of Metformin in COPD
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 212
- 主要终点
- Forced expiratory volume in the first second (FEV1)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 FEV
- •Women in childbearing age with negative pregnancy test.
排除标准
- •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.
研究组 & 干预措施
Experimental treatment
Experimental treatment: Metformin Tolerance phase dose: 850mg/24h for 2 weeks. Treatment dose: 1700mg twice daily. Pharmaceutical form: 850 mg oral tablet. Duration of treatment: Treatment will last for 3 years.
干预措施: Metformin 850Mg Tab (Drug)
Control treatment
Control treatment: Placebo Tolerance phase dose: One tablet/24h for 2 weeks. Treatment dose: Two tablets twice a day. Pharmaceutical form: Tablets with the same appearance as metformin tablets. Duration of treatment: Treatment will last for 3 years.
干预措施: Placebo (Other)
结局指标
主要结局
Forced expiratory volume in the first second (FEV1)
时间窗: At inclusion and at 3-years follow-up
The amount of air expelled during the first second of a maximal expiration, performed after a maximal inspiration.
Carbon monoxide diffusion test (DLCO)
时间窗: At inclusion and at 3-years follow-up
Pulmonary function test, in which the diffusion of gases through the pulmonary alveoli into the blood is studied.
次要结局
- Age(Baseline)
- Sex at birth(Baseline)
- Height(Baseline)
- Weight(Baseline and at 1 year, 2 years and 3 years)
- Smoking(Baseline)
- The percentage of lung volume with emphysema measured on a chest CT scan.(At inclusion and at 3-years follow-up)
- 6-minute walk distance (6MWT)(Baseline and at 1 year, 2 years and 3 years)
- Grip strength with dynamometer(Baseline and at 1 year, 2 years and 3 years)
- Renal dysfunction (microalbuminuria)(Month 6, 12, 18, 24, 30 and 36)
- Concomitant treatment(Month 6, 12, 18, 24, 30 and 36)
- Exacerbations(Month 6, 12, 18, 24, 30 and 36)
- Emergency room visits(Month 6, 12, 18, 24, 30 and 36)
- Hospitalisations(Month 6, 12, 18, 24, 30 and 36)
- Intubation(Month 6, 12, 18, 24, 30 and 36)
- Obstruction(Month 6, 12, 18, 24, 30 and 36)
- BODE Index(Baseline and month 6, 12, 18, 24, 30 and 36)
- Dyspnoea(Baseline and at 1 year, 2 years and 3 years)
- Major cardiovascular events(Month 6, 12, 18, 24, 30 and 36)
- Cancer events(Month 6, 12, 18, 24, 30 and 36)