Prospective, multicentre, double-blind, placebo-controlled, randomised, prospective clinical trial comparing the effect of metformin 850 mg twice daily with placebo in COPD patients with evidence of emphysema (by CT scan or reduced DLCO) who are known to have a rapid decrease in FEV1. Main objective: To compare the change in FEV1 at 3 years follow-up in patients receiving metformin versus placebo. Participants will take metformin (850mg) or placebo twice daily for 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
212
Tolerance phase dose: 850mg/24h for 2 weeks. Treatment dose: 1700 mg twice daily.
Tolerance phase dose: One tablet/24h for 2 weeks. Treatment dose: Two tablets twice daily.
Forced expiratory volume in the first second (FEV1)
The amount of air expelled during the first second of a maximal expiration, performed after a maximal inspiration.
Time frame: At inclusion and at 3-years follow-up
Carbon monoxide diffusion test (DLCO)
Pulmonary function test, in which the diffusion of gases through the pulmonary alveoli into the blood is studied.
Time frame: At inclusion and at 3-years follow-up
Age
Years
Time frame: Baseline
Sex at birth
Male/Female
Time frame: Baseline
Height
Centimetres
Time frame: Baseline
Weight
Kg
Time frame: Baseline and at 1 year, 2 years and 3 years
Smoking
Cigarette packs/year
Time frame: Baseline
The percentage of lung volume with emphysema measured on a chest CT scan.
Time frame: At inclusion and at 3-years follow-up
6-minute walk distance (6MWT)
Metres in 6 minutes
Time frame: Baseline and at 1 year, 2 years and 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Grip strength with dynamometer
Kg
Time frame: Baseline and at 1 year, 2 years and 3 years
BODE Index
The BODE index will result in a score of zero to ten dependent upon FEV1, body-mass index, the distance walked in six minutes, and the modified MRC dyspnea scale where 0 is the best state of health and 10 is the worst.
Time frame: Baseline and month 6, 12, 18, 24, 30 and 36
Dyspnoea
1, 2, 3, 4 or 5 grades where dyspnoea grade 1 is the best state of health and grade 5 is the worst state of health
Time frame: Baseline and at 1 year, 2 years and 3 years
Major cardiovascular events
Select from a list (Myocardial infarction/new angina/stroke) if any of these events happen.
Time frame: Month 6, 12, 18, 24, 30 and 36
Cancer events
Solid cancers Yes/No
Time frame: Month 6, 12, 18, 24, 30 and 36
Renal dysfunction (microalbuminuria)
mg/g
Time frame: Month 6, 12, 18, 24, 30 and 36
Concomitant treatment
EPOC concomitant treatment
Time frame: Month 6, 12, 18, 24, 30 and 36
Exacerbations
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36
Emergency room visits
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36
Hospitalisations
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36
Intubation
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36
Obstruction
YES/NO
Time frame: Month 6, 12, 18, 24, 30 and 36