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Metformin to Reduce Airway Glucose in COPD Patients
Phase 2 trial testing Metformin in Chronic Obstructive Pulmonary Disease in 14 participants. Completed in 1 June 2023.
| Lead sponsor | Imperial College London |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 17 May 2022 |
| Primary completion | 31 May 2023 |
| Estimated completion | 1 June 2023 |
| Sites | 1 location across United Kingdom |
Imperial College London
Adults 40 to 75, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The median concentration of glucose in sputum following 3 months treatment with metformin or placebo.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | 68.92 | 16.3 – 131.1 |
| Placebo Group | 12.2 | 10 – 13 |
The median concentration of glucose in nasal samples following 3 months treatment with metformin or placebo.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | 12.56 | 5.92 – 28.28 |
| Placebo Group | 13.5 | 6.19 – 27.83 |
The COPD Assessment Test (CAT): the CAT features 8 questions ranked from 0-5 with a minimum score of 0 and maximum possible score of 40. Higher scores indicate a greater impact on patient health due to their COPD, a difference of ≥2 is considered meaningful. The questionnaire's were completed by every participant at every visit up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | 16.6 | 6.4 – 26.8 |
| Placebo Group | 13.2 | 3.3 – 23.1 |
St George's Respiratory Questionnaire (SGRQ): the SGRQ contains 50 items with a minimum score of 0 and a maximum score of 100. Higher scores indicate a greater impact on quality of life due to COPD and a difference of ≥4 is meaningful The questionnaire's were completed by every participant at every visit up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | 42.7 | 24.4 – 61 |
| Placebo Group | 36.4 | 18.6 – 54.2 |
FEV1(Forced Expiratory Volume Test) was performed up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | 69.2 | 51 – 87.4 |
| Placebo Group | 66.1 | 46.7 – 85.5 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment Group | Placebo Group |
|---|---|---|---|
| Exacerbation of COPD with hospitalisation | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Treatment Group | Placebo Group |
|---|---|---|---|
| Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Procedural related adverse event | Respiratory, thoracic and mediastinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Abdominal cramps | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Exacerbation of COPD with hospitalisation.
Data from ClinicalTrials.gov NCT03651895 adverse events section.
Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death worldwide and affects 1.2 million people in the UK, costing the NHS \>£800 million annually. COPD patients are more susceptible to bacterial infections and both chronic and acute infections are common. COPD patients with chronic lung bacterial infection have worse quality of life, faster disease progression, more symptoms and frequent exacerbations. Acute infections are the main cause of COPD exacerbations which cause COPD patients to become acutely unwell and often result in hospitalisation especially in the winter. Antibiotics are frequently used to treat COPD exacerbations and this contributes to the development of antibiotic resistance. Therefore there is a need to develop antibiotic-independent approaches to reducing or preventing bacterial infection in COPD. The investigators have carried out work in in animal studies and in humans showing that there is a link between high levels of glucose in the lung and bacterial lung infection. Levels of glucose in the lung are higher in COPD patients compared with people without COPD. These higher glucose levels support greater bacterial growth probably because glucose is a nutrient for bacteria. Therefore reducing airway glucose has the potential to inhibit bacterial growth in COPD patients. In animal studies the investigators have demonstrated that the diabetic drug metformin decreases airway glucose and bacterial growth. The investigators wish to determine if metformin can achieve the same effects in COPD patients. Metformin is safe and cheap, and has been extensively used in COPD patients with diabetes with an excellent safety record. The primary aim of this study will be to determine whether metformin reduces lung glucose in a small group of non-diabetic COPD patients. If it demonstrates that metformin reduces lung glucose concentrations it will justify a larger clinical trial of metformin as a treatment for COPD.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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