Chronic obstructive pulmonary disease (COPD) Respiratory
Conditions
Interventions
Participants will be randomised using an online randomisation software to receive either IMP (RJx-01) or placebo once daily (OD) for 168 days (~6 months). Stratification criteria will be applied durin
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
45 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 02/02/2026: 1. Symptoms typical of COPD when stable, defined as all of: 1.1. Baseline extended MRC dyspnoea grade =3 when stable 1.2. FEV1/FVC ratio <0.7 (only if previous spirometry available) 1.3. Usually on maintenance inhaled therapy for COPD (any of long-acting muscarinic antagonist [LAMA], Long-acting beta-agonist [LABA] +/- Inhaled Corticosteroid [ICS]) 2. A clinician defined acute exacerbation of COPD (AECOPD) requiring admission to hospital and change in treatment (e.g. addition of systemic corticosteroids +/- antibiotics) 3. Able to initiate the first dose of the IMP when medically fit for discharge from hospital 4. Current or ex-smoker with cumulative smoking history =10 pack years 5. Age =45 years at time of screening 6. Predicted length of hospital stay =48 hours 7. Willing and able to consent to participate in the trial 8. Able to understand written and spoken English to a level so able to complete study measures, or with support from English-speaking family 9. If male with a partner who is a woman of childbearing potential (WOCBP), then willingness to comply with protocol contraception requirements (section 10.9) Sub-study inclusion criteria 1. Meets eligibility criteria and has consented to participate in the COPD-MINT main trial 2. Willing and able to consent to participate in the sub-study Previous inclusion criteria: 1. Symptoms typical of COPD when stable, defined as all of: 1.1. Baseline extended MRC dyspnoea grade =3 when stable 1.2. FEV1/FVC ratio <0.7 (only if previous spirometry available) 1.3. Usually on maintenance inhaled therapy for COPD (any of long-acting muscarinic antagonist [LAMA], Long-acting beta-agonist [LABA] +/- Inhaled Corticosteroid [ICS]) 2. A clinician defined acute exacerbation of COPD (AECOPD) requiring admission to hospital and change in treatment (e.g. addition of systemic corticosteroids +/- antibiotics) 3. Able to initiate the first dose of the IMP when medically fit for discharge from hospital 4. Current or ex-smoker with cumulative smoking history =10 pack years 5. Age =55 years at time of screening 6. Predicted length of hospital stay =48 hours 7. Willing and able to consent to participate in the trial 8. Able to understand written and spoken English to a level so able to complete study measures, or with support from English-speaking family 9. If male with a partner who is a woman of childbearing potential (WOCBP), then willingness to comply with protocol contraception requirements (section 10.9) Sub-study inclusion criteria 1. Meets eligibility criteria and has consented to participate in the COPD-MINT main trial 2. Willing and able to consent to participate in the sub-study
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 02/02/2026: 1. Use of, or contraindication to, metformin , any acetylcholinesterase inhibitor (AChE-I) medication (including Galantamine), or any systemic medication with significant cholinergic or anticholinergic effects within 6 months prior to screening or during the study period, except for long-acting muscarinic antagonist (LAMA) inhalers. 2. Patients with known hypersensitivity to MET, GAL or any excipients used in the formulations, including tartrazine (FD&C yellow number 5) 3. Hospital admission within the 2 weeks prior to the first day of current hospital admission. 4. =3 emergency/unplanned hospital admissions in the previous 6 months. 5. Unstable or life-threatening cardiac disease, including myocardial infarction or unstable angina in the previous 12 months (added 02/07/2025: excluding Type 2 myocardial infarction). 6. Unstable or life-threatening cardiac arrhythmia requiring intervention in the previous 3 months, QTc >500 msec or 2nd or 3rd degree Bundle Branch block, or subjects who are at increased risk of QTc prolongation in the view of the investigator including due to concurrent use of multiple medications known to increase the risk of QTc prolongation. 7. Clinical evidence of congestive cardiac failure as the primary cause of dyspnoea or physical limitation. 8. Normally bed-bound (Clinical Frailty Score 8 or higher). 9. Women of childbearing potential (WOCBP) or those who are currently pregnant or breastfeeding 10. Patients whose treatment is considered palliative due to a condition other than COPD (life expectancy 20 mg/day oral prednisolone (or equivalent systemic corticosteroid dose) consistently for >28 days immediately prior to screening. 18. Concomitant or recent treatment (<3 months) with an immunosuppressant agent (e.g. Disease-modifying antirheumatic drugs or monoclonal antibodies, with the exception of corticosteroids). Sub-study exclusion criteria: 1. Impaired blood clotting (family or medical history of impaired blood clotting, e.g., haemophilia) 2. Current use of warfarin, therapeutic doses of low molecular weight heparin or any direct oral anticoagulant (DOAC) drugs (including but not limited to betrixaban, apixaban, edoxaban, rivaroxaban, dabigatran) 3. Current use of antiplatelet agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 25/09/2025: 1. Adverse events (AEs) of CTCAE grade =3 that are at least possibly related to IMP in view of the investigator, recorded using participant self-reporting and electronic medical records at baseline (Visit 1), day 7 (Visit 2), day 29 (Visit 3), day 57 (Visit 4), day 85 (Visit 5), day 113 (Visit 6), day 141 (Visit 7), day 169 (Visit 8), follow-up at day 197 (Visit 9), and at each hospital readmission visit 2. Serious adverse events (SAEs) that are at least possibly related to IMP are recorded using electronic medical records and participant reports at baseline (Visit 1), day 7 (Visit 2), day 29 (Visit 3), day 57 (Visit 4), day 85 (Visit 5), day 113 (Visit 6), day 141 (Visit 7), day 169 (Visit 8), follow-up at day 197 (Visit 9), and at each hospital readmission visit 3. Hospital admissions (all-cause and COPD-related) are recorded through electronic medical records and participant self-reports at baseline (Visit 1) and monitored continuously until follow-up at day 197 (Visit 9) 4. Mortality (all-cause and COPD-related) is recorded using electronic medical records and death certificates from baseline (Visit 1) through follow-up at day 197 (Visit 9) Previous primary outcome measures: 1. Adverse events (AEs) of CTCAE grade =3 that are at least possibly related to IMP in view of the investigator, recorded using participant self-reporting and electronic medical records at baseline (Visit 1), day 8 (Visit 2), day 29 (Visit 3), day 57 (Visit 4), day 85 (Visit 5), day 113 (Visit 6), day 141 (Visit 7), day 169 (Visit 8), follow-up at day 197 (Visit 9), and at each hospital readmission visit 2. Serious adverse events (SAEs) that are at least possibly related to IMP are recorded using electronic medical records and participant reports at baseline (Visit 1), day 8 (Visit 2), day 29 (Visit 3), day 57 (Visit 4), day 85 (Visit 5), day 113 (Visit 6), day 141 (Visit 7), day 169 (Visit 8), follow-up at day 197 (Visit 9), and at each ho | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 02/02/2026: Exploratory outcome measures: 1. Treatment-emergent adverse events (TEAEs) are recorded using participant self-reporting and electronic medical records at all study visits from baseline (Visit 1) to follow-up at day 197 (Visit 9), as well as at each hospital readmission visit. 2. Treatment-emergent serious adverse events (TESAEs) are recorded using electronic medical records and participant reports at all study visits from baseline (Visit 1) to follow-up at day 197 (Visit 9), as well as at each hospital readmission visit. 3. Clinical assessments (heart rate, blood pressure, temperature) are recorded at baseline (Visit 1), day 7 (Visit 2), day 29 (Visit 3), day 57 (Visit 4), day 85 (Visit 5), day 113 (Visit 6), day 141 (Visit 7), day 169 (Visit 8), follow-up at day 197 (Visit 9), and at each hospital readmission visit. 4. ECG changes (QTc) are measured using standard electrocardiography (ECG) at baseline (Visit 1), day 7 (Visit 2), day 169 (Visit 8), and at each hospital readmission visit where clinically indicated. 5. Blood biomarkers (LFTs, HbA1c, full blood count, urea and electrolytes) are measured at baseline (Visit 1), day 7 (Visit 2), day 29 (Visit 3), day 57 (Visit 4), day 85 (Visit 5), day 113 (Visit 6), day 141 (Visit 7), day 169 (Visit 8), follow-up at day 197 (Visit 9), and at each hospital readmission visit. 6. Short Physical Performance Battery (SPPB) total score (5 sit-to-stand, balance score, 4-metre gait speed) is measured at baseline (Visit 1), day 29 (Visit 3), day 57 (Visit 4), day 85 (Visit 5), day 113 (Visit 6), day 141 (Visit 7), day 169 (Visit 8), follow-up at day 197 (Visit 9), and at each hospital readmission visit. 7. Individual components of the SPPB (5 sit-to-stand, balance score, 4-metre gait speed) are measured at baseline (Visit 1), day 29 (Visit 3), day 57 (Visit 4), day 85 (Visit 5), day 113 (Visit 6), day 141 (Visit 7), day 169 (Visit 8), follow-up at day 197 (Visit 9), and at eac | — |
Countries
England, United Kingdom
Contacts
Public ContactJill Clanchy
Outcome results
None listed