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Chronic Obstructive Pulmonary DiseasePhase 4NCT01247870

Metformin in Chronic Obstructive Pulmonary Disease

A Phase 4 study testing Metformin in people with Chronic Obstructive Pulmonary Disease, run by St George's, University of London at 9 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
9 sitesUnited Kingdom
Study dates
Jan 2011to May 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of COPD
  • Hospitalisation for exacerbation of COPD
  • Age ≥35 years
  • Expected to remain in hospital for at least 48 hours

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United Kingdom9 sites

  • Blackpool Teaching Hospitals NHS Trust

    Blackpool, Lancashire, FY3 8NR

  • North Tees and Hartlepool NHS Trust

    Hartlepool, Cleveland, TS24 9AH

  • East Sussex Healthcare NHS Trust

    Hastings, East Sussex, TN37 7PT

  • University Hospitals of Morecambe Bay NHS Trust

    Lancaster, Cumbria, LA9 7RG

  • Chelsea and Westminster Hospital

    London, SW10 9NH

  • St George's Hospital

    London, SW17 0QT

  • Freeman Hospital

    Newcastle, NE7 7DN

  • Lancashire Teaching Hospitals NHS Trust

    Preston, Lancashire, PR2 9HT

  • Sherwood Forest Hospitals NHS Trust

    Sutton in Ashfield, Nottinghamshire, NG17 4JL

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
Metformin, Placebo
Keywords
Chronic obstructive pulmonary disease, COPD, metformin
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Metformin 1 g twice daily for 28-35 days

  • PlaceboDrug

    Placebo

Study groups in NCT01247870
Study groupRoleWhat they receive
MetforminExperimentalMetformin 1 g twice daily for 28-35 days
Receives: Drug: Metformin
PlaceboPlacebo comparatorMatched placebo capsules
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Capillary glucose concentration

    The mean capillary glucose concentration during hospitalisation period following study entry, as a measure of both efficacy and safety.

    Measured: During hospitalisation period

Secondary outcomes (18)

  1. COPD Assessment Test score

    Measured: Study entry, hospital discharge, and follow-up

  2. Exacerbation of Chronic Pulmonary Disease Tool (EXACT) score

    Measured: Days 5, 10 and 28

  3. Time to discharge

    Number of days from hospital admission to hospital discharge

    Measured: Hospital discharge

  4. Recurrent exacerbation, readmission, and death rate

    Rates of recurrent exacerbation (defined as treatment with antibiotics and/or systemic corticosteroids for breathlessness, cough or wheeze), readmission to hospital, or death

    Measured: 3 months

  5. Insulin requirement during hospitalisation period

    Mean daily insulin use during hospitalisation period following study entry

    Measured: During hospitalisation period following study entry

  6. Haemoglobin A1c

    Mean haemoglobin A1c concentration

    Measured: Follow-up (one month post study entry)

  7. C-reactive protein concentration

    Mean concentration of C-reactive protein in the blood

    Measured: Days 7 and follow-up (one month)

  8. Body mass index

    Measured: Follow-up (one month)

  9. Waist circumference

    Measured: Follow-up (one month)

  10. Forced expiratory volume in 1 second

    Mean forced expiratory volume in 1 second (FEV1) expressed as a percentage of predicted value

    Measured: At hospital discharge and follow-up (one month)

  11. Fructosamine

    Mean serum fructosamine concentration

    Measured: At hospital discharge and follow-up (one month)

  12. Interleukin 6

    Serum concentration of IL-6 (absolute value and change from baseline)

    Measured: At hospital discharge and follow-up (one month)

  13. Interleukin 8

    Serum concentration of IL-8 (absolute value and change from baseline)

    Measured: At hospital discharge and follow-up (one month)

  14. Tumor necrosis factor alpha

    Serum concentration of TNF-alpha (absolute value and change from baseline)

    Measured: At hospital discharge and follow-up (one month)

  15. Interferon gamma

    Serum concentration of IFN-gamma (absolute value and change from baseline)

    Measured: At hospital discharge and follow-up (one month)

  16. 8-isoprostane

    Serum concentration of 8-isoprostane (absolute value and change from baseline)

    Measured: At hospital discharge and follow-up (one month)

  17. Total carbonyl stress

    Total carbonyl stress, measured in serum (absolute value and change from baseline)

    Measured: At hospital discharge and follow-up (one month)

  18. Glutathione reduced vs oxidised

    Glutathione reduced vs oxidised, measured in serum (absolute value and change from baseline)

    Measured: At hospital discharge and follow-up (one month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01247870
Sponsor's protocol ID
10.0086
Other IDs
2010-020818-28
Status last verified
May 2015
First submitted
23 Nov 2010
Last updated
7 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27174882

  • Hitchings 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.

    PubMed 26917577

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin in people with Chronic Obstructive Pulmonary Disease, run by St George's, University of London at 9 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Capillary glucose concentration (time frame: During hospitalisation period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01247870, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.

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