E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This programme of research will examine the role of beta-2 agonist as specific pharmacotherapy to reduce the incidence of Acute Lung Injury (ALI) / Acute Respiratory Distress Syndrome (ARDS) in patients undergoing elective oesophagectomy. |
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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 |
Acute respiratory distress syndrome (ARDS) is a serious condition affecting the lungs, making it difficult for the lungs to work effectiveley and get oxygen into the blood. ARDS also complicates approximately 25−30% of patients undergoing oesophagectomy (procedure to remove a portion of the lower gullet). This study aims to evaluate whether prophylactic (preventive) treatment with inhaled salmeterol will reduce the incidence of ARDS in patients undergoing elective oesophagectomy. |
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E.2.2 | Secondary objectives of the trial |
−To evaluate the effects of Salmeterol on: −global severity of illness(APACHE II, SAPS II, SOFA); and respiratory severity of illness (oxygenation [PaO2:FiO2 ratio,lung injury score, lung water, [day 0 − extubation]) −lung and systemic inflammation. −To evaluate the ALI/ARDS within 28 days of surgery; 60 day and 1 year mortality. −To evaluate the effects of salmeterol on the number of days a patient is not on a ventilator. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provision of informed consent. 2. Age >18years. 3. Planned elective transthoracic oesophagectomy. 4. Ability to use inhaler with spacer device. |
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E.4 | Principal exclusion criteria |
1. Pregnancy. 2. Current treatment with long acting beta agonist (any formulation). 3. Allergy to excipients contained in the salmeterol inhaler. 4 Current treatment with non-cardioselective beta blockers (the cardioselective beta blockers atenolol, betazolol, bisoprolol and metoprolol are permitted). 5. Treatment with an investigational medicinal product in the last 30 days. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be the development of clinically significant acute lung injury within 72 hours of oesophagectomy. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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 | 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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
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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After last patient recruited has completed all follow up questionnaires (day 90) |
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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 | 3 |
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 | 0 |
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 |