A pilot study of the use of metformin to reduce airway glucose in COPD

Phase 1

• Conditions: Chronic obstructive pulmonary disease; MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001755-12-GB
• Lead Sponsor: Imperial College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-23
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Age 40 - 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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Diagnosis of diabetes irrespective of treatment
Diabetes diagnosed on screening bloods
History of hepatic or renal impairment
Hepatic or renal impairment diagnosed on screening bloods
Excessive alcohol intake (>21 units/week)
BMI < 18.5kg/m2
Taking metformin irrespective of indication
History of allergy or hypersensitivity to metformin
Pregnancy or breastfeeding
Unable to provide informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Can metformin reduce glucose levels in the lung in COPD patients?;<br> Secondary Objective: What are the effects of metformin on:<br> 1. Glucose levels in the nose<br> 2. Bacterial infection<br> 3. Inflammation in the lung<br> 4. COPD exacerbations<br> 5. Quality of life and symptoms<br> 6. Lung function<br> ;Primary end point(s): Mean sputum concentration of glucose in participants taking metformin after 3 months compared with those taking placebo;Timepoint(s) of evaluation of this end point: After 3 months treatment with metformin or placebo

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Glucose measured in nasal SAM strips;<br> 2. Bacterial infection (sputum semi-quantitative culture);<br> 3. Inflammatory markers in sputum;<br> 4. COPD exacerbations;<br> 5. Quality of life/symptom scores;<br> 6. Lung function;<br> 7. Safety and tolerability of metformin.<br> ;Timepoint(s) of evaluation of this end point: After 3 months treatment with metformin or placebo