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Metformin to Reduce Airway Glucose in COPD Patients

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ClinicalTrials.gov Identifier: NCT03651895
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death worldwide and affects 1.2 million people in the UK, costing the NHS >£800 million annually. COPD patients are more susceptible to bacterial infections and both chronic and acute infections are common. COPD patients with chronic lung bacterial infection have worse quality of life, faster disease progression, more symptoms and frequent exacerbations. Acute infections are the main cause of COPD exacerbations which cause COPD patients to become acutely unwell and often result in hospitalisation especially in the winter. Antibiotics are frequently used to treat COPD exacerbations and this contributes to the development of antibiotic resistance. Therefore there is a need to develop antibiotic-independent approaches to reducing or preventing bacterial infection in COPD.

The investigators have carried out work in in animal studies and in humans showing that there is a link between high levels of glucose in the lung and bacterial lung infection. Levels of glucose in the lung are higher in COPD patients compared with people without COPD. These higher glucose levels support greater bacterial growth probably because glucose is a nutrient for bacteria. Therefore reducing airway glucose has the potential to inhibit bacterial growth in COPD patients.

In animal studies the investigators have demonstrated that the diabetic drug metformin decreases airway glucose and bacterial growth. The investigators wish to determine if metformin can achieve the same effects in COPD patients. Metformin is safe and cheap, and has been extensively used in COPD patients with diabetes with an excellent safety record. The primary aim of this study will be to determine whether metformin reduces lung glucose in a small group of non-diabetic COPD patients. If it demonstrates that metformin reduces lung glucose concentrations it will justify a larger clinical trial of metformin as a treatment for COPD.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Metformin Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin to Reduce Airway Glucose in COPD Patients
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: Treatment Group
Metformin 500mg bd
Drug: Metformin
Drug

Placebo Comparator: Placebo Group
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Sputum Glucose Concentration [ Time Frame: 3 months ]
    The median concentration of glucose in sputum measured using enzymatic assay


Secondary Outcome Measures :
  1. Nasal Glucose Concentrations [ Time Frame: 3 months ]
    The median concentration of glucose in nasal samples measured using enzymatic assay

  2. Sputum bacterial load [ Time Frame: 3 months ]
    The bacterial load in sputum measured using qPCR

  3. Sputum inflammatory markers [ Time Frame: 3 months ]
    The median concentration of inflammatory cells and cytokines in sputum

  4. Quality of life score [ Time Frame: 3 months ]
    CAT/SGRQ

  5. Lung function [ Time Frame: 3 months ]
    FEV1



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The inclusion criteria will be:

  • Age between 40 and 75 years
  • A clinical diagnosis of COPD confirmed with spirometry (Post-bronchodilator FEV1/FVC <70%).
  • A smoking history of at least 15 pack years
  • Absence of infection for at least 8 weeks prior to study entry
  • No use of antibiotics and oral corticosteroids at least 8 weeks prior to study entry
  • Able to understand and consent to the study procedures

Exclusion criteria:

  • Diabetes including diabetes diagnosed at screening
  • History of hepatic or renal impairment or diagnosed on screening bloods
  • Patients already taking metformin irrespective of indication
  • Known allergy or hypersensitivity to metformin
  • Pregnancy or breastfeeding
  • Any other significant medical condition likely to interfere with the study or significantly reduce lifespan
  • Unable to provide informed consent
  • Excessive alcohol intake (>21 units/week)
  • BMI < 18.5kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651895


Contacts
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Contact: Patrick Mallia, MD 004420756943751 p.mallia@imperial.ac.uk
Contact: Sebastian Johnston, MBBS s.johnston@imperial.ac.uk

Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Patrick Mallia, MD Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03651895    
Other Study ID Numbers: 18SM4819
2018-001755-12 ( EudraCT Number )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Imperial College London:
Chronic Obstructive Pulmonary Disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs