E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009026 |
E.1.2 | Term | Chronic obstructive airways disease |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The overarching research question for this body of work is to ascertain whether metformin improves recovery from COPD exacerbations.
This pilot study will address a more limited question, as a basis for future trial design: in patients admitted to hospital with COPD exacerbations, is metformin an effective treatment for acute hyperglycaemia (elevated blood sugar concentration)? |
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E.2.2 | Secondary objectives of the trial |
In patients admitted to hospital with COPD exacerbations, does metformin have beneficial effects on clinical outcome, measures of inflammation, steroid sensitivity, and airflow obstruction, which merit further study? |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1) Diagnosis of COPD based on at least one of the following criteria:
- Previously recorded airflow obstruction on spirometry (FEV1 <80% predicted, FEV1:FVC <70% predicted), without evidence of complete reversibility - Previous diagnosis of COPD by respiratory physician - Exertional breathlessness, chronic cough, or regular sputum production, in a patient who has ≥10 pack-years smoking history
(2) Exacerbation of COPD, defined by the presence of at least two of the following major features, or one major symptom and one minor feature.
Major features: - Increased breathlessness - Increased sputum volume - Increased sputum purulence
Minor features: – Upper respiratory infection within the past 5 days – Fever without other cause – Increased wheezing or cough – Increase in respiratory rate or heart rate by 20% as compared with baseline
(3) Age ≥35 years
(4) Able to enter the study within 48 hours of admission |
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E.4 | Principal exclusion criteria |
1. Prior diagnosis of diabetes mellitus requiring insulin or oral hypoglycaemic therapy 2. Hypersensitivity to metformin hydrochloride or to any of the excipients 3. Renal impairment 4. Severe sepsis 5. Metabolic acidosis 6. Decompensated type 2 respiratory failure 7. Severe congestive cardiac failure 8. Acute coronary syndrome 9. Hepatic insufficiency 10. Excessive alcohol consumption 11. Malnourished or at high risk for malnutrition 12. Moribund or not for active treatment 13. Admitted to critical care unit 14. Unable to give informed consent 15. Pregnancy or lactation |
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E.5 End points |
E.5.1 | Primary end point(s) |
The mean capillary blood glucose concentration during the hospitalisation period |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The last visit (that is, the single follow-up appointment) of the last subject in the trial. Following this, additional study-related activity will take place (including telephone and postal contact with some participants, data analysis, and report writing). However, no further participants will be recruited and no further IMP administration will take place. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 22 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 22 |