Metformin in Chronic Obstructive Pulmonary Disease
A Randomised, Double-blind, Placebo-controlled Trial of Metformin in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations: a Pilot Study
2 other identifiers
interventional
52
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 chronic-obstructive-pulmonary-disease
Started Jan 2011
Longer than P75 for phase_4 chronic-obstructive-pulmonary-disease
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 7, 2015
May 1, 2015
3.2 years
November 23, 2010
May 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Capillary glucose concentration
The mean capillary glucose concentration during hospitalisation period following study entry, as a measure of both efficacy and safety.
During hospitalisation period
Secondary Outcomes (18)
COPD Assessment Test score
Study entry, hospital discharge, and follow-up
Exacerbation of Chronic Pulmonary Disease Tool (EXACT) score
Days 5, 10 and 28
Time to discharge
Hospital discharge
Recurrent exacerbation, readmission, and death rate
3 months
Insulin requirement during hospitalisation period
During hospitalisation period following study entry
- +13 more secondary outcomes
Study Arms (2)
Metformin
EXPERIMENTALMetformin 1 g twice daily for 28-35 days
Placebo
PLACEBO COMPARATORMatched placebo capsules
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD
- Hospitalisation for exacerbation of COPD
- Age ≥35 years
- Expected to remain in hospital for at least 48 hours
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St George's, University of Londonlead
- Medical Research Councilcollaborator
- British Lung Foundationcollaborator
Study Sites (9)
North Tees and Hartlepool NHS Trust
Hartlepool, Cleveland, TS24 9AH, United Kingdom
University Hospitals of Morecambe Bay NHS Trust
Lancaster, Cumbria, LA9 7RG, United Kingdom
East Sussex Healthcare NHS Trust
Hastings, East Sussex, TN37 7PT, United Kingdom
Blackpool Teaching Hospitals NHS Trust
Blackpool, Lancashire, FY3 8NR, United Kingdom
Lancashire Teaching Hospitals NHS Trust
Preston, Lancashire, PR2 9HT, United Kingdom
Sherwood Forest Hospitals NHS Trust
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
Related Publications (2)
Hitchings AW, Baker EH, Jones PW. Handling missing items in the Exacerbations of Chronic Pulmonary Disease Tool. Eur Respir J. 2016 Aug;48(2):564-6. doi: 10.1183/13993003.00269-2016. Epub 2016 May 12. No abstract available.
PMID: 27174882DERIVEDHitchings AW, Lai D, Jones PW, Baker EH; Metformin in COPD Trial Team. Metformin in severe exacerbations of chronic obstructive pulmonary disease: a randomised controlled trial. Thorax. 2016 Jul;71(7):587-93. doi: 10.1136/thoraxjnl-2015-208035. Epub 2016 Feb 25.
PMID: 26917577DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 24, 2010
Study Start
January 1, 2011
Primary Completion
March 1, 2014
Study Completion
May 1, 2014
Last Updated
May 7, 2015
Record last verified: 2015-05