MINT-COPD
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled Trial of RJx-01 To Maintain Integrity of Muscle During Hospitalisation in Older Persons with Severe Acute Exacerbation of COPD
IRAS ID
1010818
Contact name
Neil Greening
Contact email
Sponsor organisation
University of Leicester
ISRCTN Number
ISRCTN14321370
Research summary
People living with Chronic Obstructive Pulmonary Disease (COPD) experience "flare-ups", which can result in admission to hospital and loss of muscle function. This research study is testing a new unlicensed medication called RJx-01 and aims to assess its safety and tolerability, along with its impact on muscle function and quality of life. Participants will take the medication for 6-months, starting when they are in hospital. At monthly appointments, we will conduct safety and muscle function tests.
RJx-01 is made of two medicines, Metformin (used for diabetes) and Galantamine (used for dementia), combined into a new treatment. Participants in this study will either receive RJx-01 or a placebo (a “dummy drug”) to compare the effects. The study will check how safe the treatment is, how well it is tolerated, and its effect on muscle health and quality of life.
Patients admitted to the hospital with COPD will be invited to take part. They will be randomly assigned to receive either RJx-01 or a placebo (a "dummy" treatment) in daily sachets for 168 days, starting when they leave the hospital. During this period, participants will be asked to attend monthly follow-up visits at Glenfield Hospital's Respiratory Biomedical Research Centre. At each visit, participants will receive more of their assigned treatment and have their health monitored through tests on breathing, muscle strength, body composition, blood, sputum (mucus), and urine samples.
Participation is voluntary, and participants can choose to stop at any time without affecting their standard medical care. This trial is organised by the University of Leicester and Rejuvenate Biomed, funded by the Wellcome Leap Dynamic Resilience Program. The findings will help to understand the potential of RJx-01 as a new treatment option for COPD patients to preserve muscle health and improve recovery after hospital admissions. Results will be published, but personal information will remain confidential and anonymised.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0032
Date of REC Opinion
28 Mar 2025
REC opinion
Further Information Favourable Opinion