Metformin in COPD - Version 1.1

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled trial of metformin in chronic obstructive pulmonary disease (COPD) exacerbations: a pilot study

• IRAS ID

  52262

• Contact name

  Emma H Baker

• Eudract number

  2010-020818-28

• ISRCTN Number

  N/A

• Research summary

  Does metformin lower the blood sugar level in patients suffering from exacerbations of chronic obstructive pulmonary disease (COPD)?COPD is the fourth leading cause of death worldwide, and a major cause of ill health. In the UK, it affects some 3.7 million people and causes over 30,000 deaths per year. It is usually, but not always, caused by smoking. Most people affected are over 65-years-old. Sufferers experience progressively worsening cough, sputum production, breathlessness and exercise limitation. This is punctuated by ??flare-ups?? (exacerbations), when their symptoms worsen substantially. Approximately 25% of patients hospitalised for exacerbations die within a year, and over 50% within 5 years. There is a pressing need for new and improved treatments for COPD exacerbations.This study will assess the effect of metformin, a tablet medication, in COPD exacerbations. Metformin has been in common use for over 50 years in patients with diabetes, to lower the blood sugar level. In COPD exacerbations, the blood sugar level is often high, and the higher it is, the more likely the patient will have a poor outcome. This led us to speculate that lowering the sugar level with metformin may improve outcomes from COPD exacerbations. However, COPD and diabetes are quite different diseases, and we do not know whether metformin will work as a sugar-lowering medicine in COPD exacerbations. We need to confirm this before we can perform larger studies to assess its effect on outcomes such as readmission and mortality rates. We will test this in a 1-month trial involving 46 patients hospitalised for COPD, half of whom will take metformin, and the other half a dummy tablet. Neither the patients nor the researchers know who is taking which. We will measure their sugar levels by regular finger-prick tests, and then compare the average readings in the two groups.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/62

• Date of REC Opinion

  16 Sep 2010

• REC opinion

  Favourable Opinion