E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diagnosed at a GP visit as suffering from acute exacerbation of COPD a. Medical history of COPD b. Increase in dyspnoea AND increase of (non-purulent) sputum volume
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MedDRA Classification |
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 |
Double-blinded placebo-controlled randomised clinical trials (RCTs) have made major contributions to medical research. But they are associated with three major issues. Firstly, the costs of conducting these studies can often be prohibitive. Secondly, the data are often collected de novo with study-specific case report forms rather than using existing clinical records. But a considerable amount of the data needed in RCTs is increasingly collected as part of routine health care. Thirdly, RCTs now often recruit participants who are not representative of patients who subsequently receive treatment in the real world clinical practice. A major opportunity in extending research opportunities and improving the public health value of RCTs could be by randomising patients at the point of care with data collection and follow up conducted by using the routinely collected health care records. This is also known as RCTs within the database. With this design, the research costs are reduced and length |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to measure clinical and quality-of-life outcomes and to compare these outcomes in participants prescribed antibiotics or usual care. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Study inclusion criteria (i) Age 40 years or older ii) Diagnosed at a GP visit as suffering from acute exacerbation of COPD a. Medical history of COPD b. Increase in dyspnoea and sputum volume c. Sputum that is non-purulent iii) Able and willing to provide informed consent to study participation iv) Subjects who in the opinion of the GP Investigator could be prescribed an antibiotic
Study exclusion criteria (i) COPD exacerbation in the last 28 days (ii) Immediate referral to specialist care for treatment of COPD exacerbation (iii) Prescribed an antibiotic in the previous 3 months (iv) Contra-indication to antibiotics. Further details can be found in the British National Formulary (section 5)
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E.4 | Principal exclusion criteria |
(i) Purulent sputum (as determined by GP) (ii) COPD exacerbation in the last 28 days (iii) Immediate referral to specialist care for treatment of COPD exacerbation (iv) Prescribed an antibiotic in the previous 3 months (v) Contra-indication to antibiotics. Further details can be found in the British National Formulary (section 5)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to evaluate the feasibility of conducting randomised clinical trials within the database. The evaluation of the methodological endpoint (i.e., the feasibility of the trial) will consist of a descriptive analysis of the recruitment rate and characteristics of the study population compared to other patients in GPRD exposed to study medication. |
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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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 50 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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3 months after start of the study. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |