Metformin in Chronic Obstructive Pulmonary Disease
Recruitment status was Not yet recruiting
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.
Chronic Obstructive Pulmonary Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-blind, Placebo-controlled Trial of Metformin in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations: a Pilot Study|
- Capillary glucose concentration [ Time Frame: During hospitalisation period ] [ Designated as safety issue: Yes ]The mean capillary glucose concentration during hospitalisation period following study entry, as a measure of both efficacy and safety.
- COPD Assessment Test score [ Time Frame: Study entry, hospital discharge, and follow-up ] [ Designated as safety issue: No ]
- Exacerbation of Chronic Pulmonary Disease Tool (EXACT) score [ Time Frame: Days 5, 10 and 28 ] [ Designated as safety issue: No ]
- Time to discharge [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]Number of days from hospital admission to hospital discharge
- Recurrent exacerbation, readmission, and death rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]Rates of recurrent exacerbation (defined as treatment with antibiotics and/or systemic corticosteroids for breathlessness, cough or wheeze), readmission to hospital, or death
- Insulin requirement during hospitalisation period [ Time Frame: During hospitalisation period following study entry ] [ Designated as safety issue: No ]Mean daily insulin use during hospitalisation period following study entry
- Haemoglobin A1c [ Time Frame: Follow-up (one month post study entry) ] [ Designated as safety issue: No ]Mean haemoglobin A1c concentration
- C-reactive protein concentration [ Time Frame: Days 7 and follow-up (one month) ] [ Designated as safety issue: No ]Mean concentration of C-reactive protein in the blood
- Body mass index [ Time Frame: Follow-up (one month) ] [ Designated as safety issue: No ]
- Waist circumference [ Time Frame: Follow-up (one month) ] [ Designated as safety issue: No ]
- Forced expiratory volume in 1 second [ Time Frame: At hospital discharge and follow-up (one month) ] [ Designated as safety issue: No ]Mean forced expiratory volume in 1 second (FEV1) expressed as a percentage of predicted value
- Response to cutaneous steroid application (McKenzie test) [ Time Frame: Study day >=5 ] [ Designated as safety issue: No ]Skin blanch response to topical application of steroid according to McKenzie protocol
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Metformin 1 g twice daily for 28-35 days
Metformin 1 g twice daily for 28-35 days
Placebo Comparator: Placebo
Matched placebo capsules
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 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. 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 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.
|Contact: Emma H Baker, MBChB, PhD||020 8725 firstname.lastname@example.org|
|St George's Hospital||Not yet recruiting|
|London, United Kingdom, SW17 0QT|
|Principal Investigator: Andrew W Hitchings, BSc MBBS|
|Chelsea and Westminster Hospital||Not yet recruiting|
|London, United Kingdom, SW10 9NH|
|Principal Investigator: Dilys Lai, BSc MBBS MD|
|Study Chair:||Emma H Baker, MBChB PhD||St George's, University of London|
|Principal Investigator:||Andrew W Hitchings, BSc MBBS||St George's Healthcare NHS Trust|