2025-520972-24-00招募中3 期
Exploring the anti-aging effects of Metformin in COPD
Fundacion Instituto De Investigacion Sanitaria De Navarra17 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2025年11月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 17
- 主要终点
- Change in FEV1 at baseline and 3-year follow-up.
研究概览
简要总结
To compare the change in FEV1 at 3 years of follow-up in patients receiving metformin vs. placebo.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent prior to any study-specific procedure.
- •Male or female, 40 to 75 years of age, inclusive, at the time of selection.
- •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).
- •Have a post-bronchodilator FEV1> 40% ≤70% of the predicted value at screening (Visit 1).
- •Having a 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 meet the requirements of the study, in the judgment of the Investigator.
- •Have any type of emphysema (centrolobulillar or paraseptal) reported by an expert radiologist.
- •Have a certified drop in lung function in the last 3 years >40ml/ml per year of FEV
- •Women of childbearing age with negative pregnancy test.
排除标准
- •Participation in another clinical trial with any marketed or investigational biologic drug within 4 months prior to screening.
- •History of cancer (within 5 years prior to Visit 1), except non-metastatic skin cancer and non-melanoma.
- •Patients who cannot perform spirometry maneuvers or tolerate plethysmography.
- •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.
- •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.
- •Patients taking oral corticosteroids chronically.
- •History of respiratory tract infection (including upper respiratory tract) and/or pulmonary exacerbation within 6 weeks prior to screening.
- •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.
- •Known active tuberculosis.
- •History of interstitial lung or massive pulmonary thromboembolic disease.
- •History of bronchiectasis secondary to respiratory diseases other 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) 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.
- •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.
结局指标
主要结局
Change in FEV1 at baseline and 3-year follow-up.
Change in FEV1 at baseline and 3-year follow-up.
次要结局
- Age
- Sex at birth
- Height
- Baseline weight and annually until the end of follow-up.
- Baseline smoking status.
- Blood tests at baseline and annually until the end of follow-up.
- Urinalysis with baseline renal function and annually until the end of follow-up.
- Baseline and 3-year microbiota analysis.
- Percentage of lung volume affected with emphysema at baseline and 3-year follow-up.
- COPD assessment test (CAT), baseline and every 6 months until the end of follow-up.
- mMRC scale at baseline and annually until the end of follow-up.
- St. George's Respiratory Questionnaire (SGRQ), baseline and every 6 months until the end of follow-up.
- Concomitant respiratory treatment, baseline and every 6 months until the end of follow-up.
- Number of annual exacerbations, doctor visits, hospitalisations.
- BODE index at baseline and annually until the end of follow-up.
- 6 minutes walking test (6MWD) at baseline and annually until the end of follow-up.
- Hand grip strength of the dominant hand baseline and annually until the end of follow-up.
- Incidence of lung cancer and other solid tumours throughout follow-up.
- Incidence of myocardial infarction, new angina, stroke, renal failure throughout follow-up.
研究者
Alberto Labiano Tabar
Scientific
Fundacion Instituto De Investigacion Sanitaria De Navarra
研究点 (17)
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