E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
- Chronic rejection at 1 and 2 year post-lung transplantation - Mortality at 1 and 2 year post-lung transplantation - Acute rejection rate at 1 and 2 post-lung transplantation - Infection rate at 1 and 2 year post-lung transplantation - Evolution of airway inflammation and pulmonary function during the first and second year post-lung transplantation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029888 |
E.1.2 | Term | Obliterative bronchiolitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049202 |
E.1.2 | Term | Bronchiolitis obliterans |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068805 |
E.1.2 | Term | Follicular bronchiolitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019319 |
E.1.2 | Term | Heart-lung transplant rejection |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025127 |
E.1.2 | Term | Lung transplant |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050433 |
E.1.2 | Term | Prophylaxis against lung transplant rejection |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050437 |
E.1.2 | Term | Prophylaxis against heart and lung transplant rejection |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051604 |
E.1.2 | Term | Lung transplant rejection |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056409 |
E.1.2 | Term | Heart and lung transplant |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016547 |
E.1.2 | Term | FEV |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016549 |
E.1.2 | Term | FEV 1 abnormal |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016550 |
E.1.2 | Term | FEV 1 decreased |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016553 |
E.1.2 | Term | FEV 1 low |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- Prevalence of chronic rejection at 1 and 2 year post-transplant - Overall survival at 1 and 2 year post-transplant
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E.2.2 | Secondary objectives of the trial |
- Acute rejection rate at 1 and 2 year post-transplant - Infection rate at 1 and 2 year post-transplant - Evolution of pulmonary function (FEV1 and FEF25-75) during the first and second year after transplantation - Evolution of BAL cellularity, protein levels (e.g. IL-8, IL-17) and microbiology (e.g. Chlamydia, Mycoplasma, Pseudomonas species or other bacterial or viral colonisations) during the first and second year after transplantation
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Azithromycin for Bronchiolitis Obliterans Syndrome
In case a patient from the AZI001 prevention-study develops chronic rejection (BOS), the study-drug (placebo or azithromycin) will be stopped and the patient will be shifted to treatment with the active drug (azithromycin 250 mg daily for 5 days, followed by 250 every other day). All other treatment options will remain available for every patient all the time after transplantation (e.g. other strategies used to tackle BOS as shifting from cyclosporin to tacrolimus, from azathioprine to mycophenolate mofetil, etc…). Patiens are in life-long routine follow-up after lung tarnsplantation and will be evaluated per routine follow up protocol with regular clinical, radiological, biochemical (blood, broncho-alveolar lavage) and/or histological examination. |
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E.3 | Principal inclusion criteria |
- Stable LTx recipients at discharge after transplantation. - Signed informed consent - Adult (age at least 18 years old at moment of transplantation) - Able to take oral medication
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E.4 | Principal exclusion criteria |
- Prolonged and/or complicated ICU-course after transplantation. - Early (<30 days post-transplant) post-operative death - Major suture problems (airway stenosis or stent) - Retransplantation (lung) - Previous transplantation (solid organ) - Multi-organ transplantation (lung+ other solid organ)
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E.5 End points |
E.5.1 | Primary end point(s) |
- Prevalence of chronic rejection at 1 and 2 year post-transplant - Overall survival at 1 and 2 year post-transplant
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | 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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
In case of chronic rejection/BOS, study drug (azi or plac) is shifted to active azithromycin |
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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 | 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
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Forseen for 24-12-2009, or 05-11-07 in case of reaching primary end-point before this date. |
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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 | 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 |