Metformin in Chronic Obstructive Pulmonary Disease
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Chronic Obstructive Pulmonary Disease |
| Intervention | Drug: Metformin Drug: Placebo |
| Phase | Phase 4 |
| Sponsor | St George's, University of London |
| Responsible Party | St George's, University of London |
| ClinicalTrials.gov Identifier | NCT01247870 |
| First Received | November 23, 2010 |
| Last Updated | March 4, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 23, 2010 |
|---|---|
| Last Updated Date | March 4, 2014 |
| Start Date | January 2011 |
| Estimated Primary Completion Date | May 2014 |
| Current Primary Outcome Measures | 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. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin in Chronic Obstructive Pulmonary Disease |
|---|---|
| Official Title | A Randomised, Double-blind, Placebo-controlled Trial of Metformin in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations: a Pilot Study |
| Brief Summary | 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. |
| Detailed Description | 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. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Chronic Obstructive Pulmonary Disease |
| Intervention | Drug: Metformin Metformin 1 g twice daily for 28-35 days Drug: Placebo Placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 52 |
| Estimated Completion Date | May 2014 |
| Estimated Primary Completion Date | March 2014 |
| Eligibility Criteria | Inclusion Criteria: - Diagnosis of COPD - Hospitalisation for exacerbation of COPD - Age ≥35 years - Expected to remain in hospital for at least 48 hours Exclusion Criteria: - Prior diagnosis of diabetes mellitus requiring insulin or oral hypoglycaemic therapy - Hypersensitivity to metformin hydrochloride or to any of the excipients - Renal impairment - Severe sepsis - Metabolic acidosis - Decompensated type 2 respiratory failure - Severe congestive cardiac failure - Acute coronary syndrome - Hepatic insufficiency - Excessive alcohol consumption - Malnourished or at high risk for malnutrition - Moribund or not for active treatment - Admitted to critical care unit - Unable to give informed consent - Pregnancy or lactation |
| Gender | Both |
| Ages | 35 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01247870 |
|---|---|
| Other Study ID Numbers | 10.0086 |
| Has Data Monitoring Committee | No |
| Information Provided By | St George's, University of London |
| Study Sponsor | St George's, University of London |
| Collaborators | Medical Research Council British Lung Foundation |
| Investigators | Study Chair: Emma H Baker, MBChB PhD St George's, University of LondonPrincipal Investigator: Andrew W Hitchings, BSc MBBS St George's Healthcare NHS Trust |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| North Tees and Hartlepool NHS Trust | Hartlepool, Cleveland, United Kingdom, TS24 9AH |
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| University Hospitals of Morecambe Bay NHS Trust | Lancaster, Cumbria, United Kingdom, LA9 7RG |
| East Sussex Healthcare NHS Trust | Hastings, East Sussex, United Kingdom, TN37 7PT |
| Blackpool Teaching Hospitals NHS Trust | Blackpool, Lancashire, United Kingdom, FY3 8NR |
| Lancashire Teaching Hospitals NHS Trust | Preston, Lancashire, United Kingdom, PR2 9HT |
| Sherwood Forest Hospitals NHS Trust | Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL |
| St George's Hospital | London, United Kingdom, SW17 0QT |
| Chelsea and Westminster Hospital | London, United Kingdom, SW10 9NH |
| Freeman Hospital | Newcastle, United Kingdom, NE7 7DN |