Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled Trial of Metformin in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations: a Pilot Study
The purpose of this study is to determine the effect of a tablet medication, called metformin, in flare-ups (exacerbations) of chronic obstructive pulmonary disease. The investigators believe that metformin may effectively control the blood sugar level during COPD exacerbations. This is important because there is evidence that a high blood sugar level during exacerbations may be linked with a worse prognosis. The investigators also think that metformin may have other potentially useful effects on inflammation, antioxidant levels, the effectiveness of steroid treatment, and recovery.
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 the investigators do not know
whether metformin will work as a sugar-lowering medicine in COPD exacerbations. The
investigators need to confirm this before the investigators can perform larger studies to
assess its effect on outcomes such as readmission and mortality rates.
The investigators will test this medicine in a 1-month trial in patients hospitalised for
COPD exacerbations. The target sample size is 69 patients, with a minimum of 48 patients
required for primary endpoint analysis. Two-thirds of the patients will take metformin, and
one-third a dummy (placebo) tablet. Neither the patients nor the researchers know who is
taking which. The investigators will measure their sugar levels by regular finger-prick
tests, and then compare the average readings in the two groups. The investigators will also
assess the medicine's effects on other markers of blood sugar level, and carry out
additional exploratory investigations on the effect of the medicine on clinical outcomes,
markers of inflammation, and markers of oxidative/carbonyl stress and steroid
responsiveness.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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