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Developmental Clinical Studies - A clinical trial of metformin in COPD exacerbations

发育性临床研究 - 二甲双胍治疗慢性阻塞性肺病 (COPD) 急性加重的临床试验

基本信息

批准号：
MR/J010235/1
负责人：
Emma H Baker
金额：
$ 28.5万
依托单位：
St George's, University of London
依托单位国家：
英国
项目类别：
Research Grant
财政年份：
2012
资助国家：
英国
起止时间：
2012 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=MR%2FJ010235%2F1
关键词：
Developmental Clinical Studies clinical trial

项目摘要

CONTEXTChronic obstructive pulmonary disease (COPD) is a lung disease that is usually caused by smoking. People with COPD feel short of breath and have a chronic cough. The condition worsens steadily, limiting exercise and normal activities. These symptoms are caused by damage to the breathing tubes which carry air into the lungs and to the air sacs where oxygen crosses from the air into the blood. In the UK, COPD affects around 3.7 million people and causes over 30,000 deaths per year. It is the fourth most common cause of death worldwide.From time to time, COPD patients experience attacks, where they feel more breathless or cough up more phlegm (sputum). These attacks are called exacerbations and are often set off by infection. Exacerbations are major events for people with COPD. During an exacerbation, COPD patients need more treatment and may require admission to hospital. It can take weeks to recover fully from an exacerbation and some people never get back to how they were before the exacerbation. Unfortunately, despite current best treatment, many people die during the weeks, months and years after an exacerbation. New treatments are required to prevent deaths and speed up recovery after exacerbations.AIMThe overall aim of our research is to see whether a drug called metformin can help COPD patients recover more quickly or survive longer after an exacerbation.Metformin is usually used to lower blood sugar in patients with diabetes. We have found that most patients admitted to hospital for COPD exacerbations have high blood sugar. The higher their blood sugar, the less well they recover from their exacerbation. We therefore think that using metformin to lower blood sugar in COPD patients during exacerbations could improve recovery. Metformin can also dampen down inflammation and mop-up harmful substances called free radicals. These effects could be beneficial for COPD patients with exacerbations. To test our theory we looked back at hospital records of COPD patients. We found that patients leaving hospital on metformin survived longer than those without metformin. This finding is encouraging, but must be interpreted cautiously, as there are several possible explanations. We now need to test the benefits of metformin in clinical trials.THE STUDYPatients admitted to hospital with COPD exacerbations will be invited to take part in the trial. Those who agree will receive all the usual treatments for COPD exacerbations. In addition, they will take a study treatment as a capsule twice daily for 1 month. Participants will be allocated by chance (randomisation) to receive metformin or no medicine (placebo) in the capsule. Neither we nor the participants will know who is taking what. This will allow us to make an unbiased assessment of the effects of metformin.We will assess the benefits of metformin by comparing blood glucose between patients during hospital admission and over the whole study using a test called fructosamine. We will check that people taking metformin don't become more unwell or develop dangerous side effects and that they can tolerate the tablets. We will also get some idea of whether metformin helps them recover more quickly from their COPD exacerbations. However this will need to be tested more thoroughly in the future in a larger group of patients.POTENTIAL BENEFITSAt the end of this trial we will know whether metformin can lower blood sugar safely in patients with COPD exacerbations. The next step will be to test metformin in a larger number of COPD patients to see if it can help them to recover more quickly from their exacerbations. Metformin is cheap and widely available. If it works it could quickly be adopted as a new treatment for these patients.

背景慢性阻塞性肺病（COPD）是一种通常由吸烟引起的肺部疾病。患有慢性阻塞性肺病 (COPD) 的人会感到呼吸短促并患有慢性咳嗽。病情不断恶化，限制了运动和正常活动。这些症状是由将空气输送到肺部的呼吸管和氧气从空气进入血液的气囊损坏引起的。在英国，慢性阻塞性肺病影响约 370 万人，每年导致超过 30,000 人死亡。它是全球第四大常见死因。慢性阻塞性肺病患者有时会出现呼吸困难或咳出更多痰的症状。这些发作称为恶化，通常由感染引发。对于慢性阻塞性肺病患者来说，病情加重是一件重大事件。在病情恶化期间，COPD 患者需要更多治疗，并可能需要入院。从恶化中完全恢复可能需要数周时间，并且有些人永远无法恢复到恶化之前的状态。不幸的是，尽管目前有最好的治疗，但许多人在病情恶化后的几周、几个月甚至几年内死亡。需要新的治疗方法来预防死亡并加速病情加重后的康复。目的我们研究的总体目的是看看一种名为二甲双胍的药物是否可以帮助 COPD 患者更快地康复或在病情加重后生存更长的时间。二甲双胍通常用于降低糖尿病患者的血糖。我们发现大多数因慢性阻塞性肺病恶化入院的患者都有高血糖。他们的血糖越高，他们从病情恶化中恢复的情况就越差。因此，我们认为使用二甲双胍降低 COPD 患者急性加重期间的血糖可以改善康复情况。二甲双胍还可以抑制炎症并清除称为自由基的有害物质。这些作用可能对慢性阻塞性肺病急性加重患者有益。为了检验我们的理论，我们回顾了慢性阻塞性肺病患者的医院记录。我们发现，服用二甲双胍的患者出院后比未服用二甲双胍的患者存活时间更长。这一发现令人鼓舞，但必须谨慎解释，因为有几种可能的解释。我们现在需要在临床试验中测试二甲双胍的益处。研究将邀请因慢性阻塞性肺病恶化入院的患者参加试验。同意的人将接受所有慢性阻塞性肺病恶化的常规治疗。此外，他们还将服用研究治疗胶囊，每天两次，持续 1 个月。参与者将被随机分配（随机）接受二甲双胍或胶囊中不含药物（安慰剂）。我们和参与者都不知道谁在拿什么。这将使我们能够对二甲双胍的效果进行公正的评估。我们将通过使用果糖胺测试比较患者入院期间和整个研究期间的血糖来评估二甲双胍的益处。我们将检查服用二甲双胍的人不会变得更加不适或出现危险的副作用，并且他们可以耐受这些药片。我们还将了解二甲双胍是否可以帮助他们从慢性阻塞性肺病恶化中更快地恢复。然而，未来需要在更大的患者群体中进行更彻底的测试。潜在的好处在本次试验结束时，我们将知道二甲双胍是否可以安全地降低 COPD 急性加重患者的血糖。下一步将在更多的慢性阻塞性肺病患者中测试二甲双胍，看看它是否可以帮助他们更快地从病情恶化中恢复过来。二甲双胍价格便宜且广泛使用。如果有效的话，它可能会很快被用作这些患者的新治疗方法。