RecruitingPhase IIInterventional

Maintaining the integrity of muscle during hospitalisation in older persons with severe acute exacerbation of chronic obstructive pulmonary disease (MINT-COPD)

This study is investigating a new medicine called RJx-01 for people over 45 who have Chronic Obstructive Pulmonary Disease (COPD) and are admitted to hospital due to a flare-up. When people with COPD have these flare-ups, they can lose muscle strength. This research aims to check if RJx-01 is safe, how well people tolerate it, and if it can help maintain muscle strength and improve their quality of life. Participants will take RJx-01 or a dummy medicine for six months, starting from hospital discharge. They will have monthly check-ups to monitor their health and muscle function. The study combines two existing medicines, metformin and galantamine, into this new treatment.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Leicester

Enrolment target

Start

12 May 2025

Estimated completion

30 Nov 2026

Chronic obstructive pulmonary disease (COPD)

What is this study about?

When people with Chronic Obstructive Pulmonary Disease (COPD) have a serious flare-up that requires them to go to hospital, it can unfortunately lead to them losing some of their muscle strength. This can make it harder to recover and get back to their usual activities. This study, called MINT-COPD, is looking into a new medicine, RJx-01, specifically designed to help protect muscles during and after a hospital stay for a COPD flare-up.

RJx-01 is a new combination of two medicines that are already used for other health conditions: metformin (used for diabetes) and galantamine (used for memory problems like dementia). By combining them, researchers hope to create a new way to help people with COPD keep their muscle strength. The study will carefully check if this new medicine is safe for people with COPD, how well they tolerate it, and if it positively affects their muscle function and overall quality of life.

Ultimately, the goal of this research is to find new and better ways to support people with COPD, helping them maintain their physical strength and improve their recovery after a hospital stay. The information gathered from this study could be very important in developing future treatments to help people with COPD live more active and healthier lives.

Key takeaways

This study is testing a new medicine called RJx-01 for people with COPD flare-ups.
It aims to protect muscle function and improve quality of life after hospitalisation.
Participants will take the medicine or a dummy pill for six months with monthly check-ups.
The study combines two existing drugs, metformin and galantamine, into a new treatment.
Your health will be closely monitored, and you can stop participating at any time.
The findings could help improve future care for people with COPD.

Who may be eligible?

This study is looking for people who are 45 years old or older and have COPD. To join, you must be currently in hospital because of a severe COPD flare-up that required changes to your treatment, like needing steroids or antibiotics.

You should have a history of smoking, either currently or in the past, for at least 10 years. You'll also need to be able to understand and speak English well enough to take part in discussions and tests, or have family support to help you with this. Importantly, you must be well enough to start taking the study medicine when you are ready to leave the hospital.

There are also some medical details that the study doctors will check, such as your past breathing test results and the usual medicines you take for your COPD. They will make sure it's safe for you to take part, especially checking for any kidney or heart problems, and certain other medical conditions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 45 years old or older?
Are you currently in hospital due to a severe COPD flare-up?
Do you have a history of smoking for at least 10 years (current or ex-smoker)?
Are you able to speak and understand English, or have family support to help?
Are you well enough to start a new medicine when you leave hospital?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be given either the new medicine RJx-01 or a dummy medicine (a placebo) in daily sachets for 168 days, which is about six months. You'll start taking it once you are well enough to leave the hospital.

After leaving the hospital, you'll need to attend monthly follow-up visits at Glenfield Hospital's Respiratory Biomedical Research Centre. At these visits, you'll receive your next supply of medicine. The research team will monitor your health with examinations and collect samples of your blood, mucus (sputum), and urine. They will also perform tests on your breathing and muscle strength to see how you are doing. The study also includes optional muscle biopsies, an extra short procedure where they take a tiny piece of muscle tissue, usually from your leg, after numbing the skin. These extra tests and samples help the researchers understand the effects of the medicine.

Throughout the study, trained staff like exercise physiologists, doctors, and nurses will guide you through all the tests. You can choose to stop participating at any time without affecting your usual medical care.

Potential risks and benefits

Taking part in this study is completely up to you, and you can stop at any time without it affecting your regular medical care. Potential benefits include helping researchers learn more about how to support people with COPD in keeping their muscle strength and improving recovery after hospital stays, which could help future patients. You might also find that the new medicine helps you, although we can't guarantee that. There are some potential risks. RJx-01 is made from two medicines, metformin and galantamine, which are known to have side effects. Metformin can cause tummy problems like diarrhoea, and very rarely, a serious but treatable condition called lactic acidosis. To reduce this risk, doctors will carefully check your health before and during the study. Galantamine can affect your heart rate, so your heart will be monitored with ECGs. You'll start on a lower dose, which will be slowly increased if it's safe. Beyond the study medicine, you'll have extra blood, breathing, and sputum tests, which are common but involve minor discomfort. For the optional muscle biopsy, you might feel some soreness and have a small scar. The research team will carefully monitor you for any problems and explain everything fully.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals of Leicester NHS Trust
City only
Leicester, England

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a long-term lung condition that makes it hard to breathe.

What is a 'dummy drug' or placebo?

A placebo is a treatment that looks exactly like the study medicine but contains no active ingredients. It's used to fairly compare the effects of the real medicine.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you are receiving RJx-01 or the placebo until the study is over. This helps ensure the results are fair.

Can I stop participating in the study at any time?

Yes, your participation is completely voluntary, and you can choose to leave the study at any time without it affecting your standard medical care.

Who is funding this research?

This study is funded by the Wellcome Leap Dynamic Resilience Program, an organisation that supports scientific research.

How to find out more

Jill Clanchy

mint-copd@leicester.ac.uk +44 (0)116 258 3370 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.