E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and secondary to Sarcoid
Patients devolop pulmonary hypertension for various reasons, two common causes are Chronic Obstructive Pulmonary disease and Sarcoid. Once developed it may go on to cause right heart failure and severe breathlessness and eventually death. We believe that the use of bosentan may lower the pulmonary hypertension and improve symptoms. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037400 |
E.1.2 | Term | Pulmonary hypertension |
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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 |
Patients devolop pulmonary hypertension for various reasons, two common causes are Chronic Obstructive Pulmonary disease and Sarcoid. Once developed it may go on to cause right heart failure and severe breathlessness and eventually death.
We believe that the use of bosentan may lower the pulmonary hypertension and improve symptoms. We therefore wish to trial the use of bosenten in patients with secondary pulmonary hypertension and see if after a period of treatment their pulmonary pressure falls, if their lung function improves, if their exercise tolerance improves and if quality of life improve. |
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E.2.2 | Secondary objectives of the trial |
To ensure that Bosentan is a safe and well tolerated treatment in patients with secondary pulmonary hypertension. This would be answered by monitoring patients very carefully whilst on the treatment and reporting any side effects. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Any Patient with Chronic Obstructive Pulmonary Disease or Sarcoid with Pulmonary Hypertension. Pulmonary hypertension is defined as a mean pulmonary artery pressure in excess of 20mmHg at rest. Pulmonary hypertension is defined as an elevated mean pulmonary artery pressure of 20 mmHg or greater at rest or 30 mmHg with exercise. |
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E.4 | Principal exclusion criteria |
Bosentan is contraindicated in patients with moderate to severe liver dysfunction and therefore this is an exclusion criteria.
There is limited experience with Bosentan in patients with a body weight below 40 kg, although this is not an absolute exclusion criteria this would require more frquent monintoring and is a relative contraindication for inclusion in the trial.
Excessive age is a relative contraindication given the number of clinic visits(>85 years old).
Children Safety and efficacy in patients under the age of 12 years have not been established so this is an exclusion criteria. (Age <12)
Pregnancy is absolute ecxlusion to the trial - therefore females entering the trial of child bearing age would need two forms of contraception and a pregnancy test prior to entry. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end points in the trial would to be to review patients before treatment and after 1 year of treatment. The end points studied would be; 1 Survival 2 Pulmonary pressures monitored by Right Heart Catheter. 3 Exercise tolerance - measured by the six minute walk test. 4 Lung function tests 5 Quality of Life assessment 6 Echo appearence of right ventricle and pulmonary pressures |
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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 | 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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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The end of the trial for each patient is after 1 year of therapy with Bosentan and after their yearly assessment i.e. their right heart catheter, echo, 6 minute walk test, quality of life assessment and lung function tests.
the patient would then enter our rountine follow-up of patients with pulmonary hypertension at St Georges Hospital. |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |