E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post Lung Transplantation Chronic Rejection identified as bronchiolitis obliterans syndrome (BOS) |
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MedDRA Classification |
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 |
To determine the efficacy of azithromycin therapy in lung transplant recipients with BOS by determining the change in FEV1 after 3 months
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E.2.2 | Secondary objectives of the trial |
Secondary outcome measures:
To measure the change in airflow limitation by measuring other indices of airflow obstruction ie FEV1/FVC, exhaled Nitric Oxide, total lung capacity measured by body plethysmography, phase 3 of the alveolar plateau measured by single breath oxygen washout, exercise capacity as measured by the 6 minute walk test.
To measure the change in health status as measured by the Short Form 36 and Chronic Respiratory Questionnaire
Inflammatory end points for the study will be change in BAL and airway biopsy neutrophil counts
From Bronchoscopic bronchoalveolar lavage (BAL) fluid The change in BAL sCD14 The change in quorum signal levels The change in BAL LPS Clinical microbiological testing, to include quantitative PCR for cytomegalovirus
Change in scar collagen deposition in the airway Change in reticular basement membrane thickening, in airway biopsies
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria:
1. Lung transplant recipient 2. Male or Female 3. Age 16 years or over 4. Airflow limitation – FEV1 < 80% maximum recorded post transplant 5. Ability to give Informed Consent
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E.4 | Principal exclusion criteria |
Exclusion criteria:
1. Airflow limitation caused by other clinical problems (e.g clinical infection) 2. Known hypersensitivity to Azithromycin or any of the macrolide antibiotics 3. Participation in another drug related trial within 90days 4. Severe renal or hepatic impairment 5. Use of concomitant medication that would interact with azithromycin
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point will be the change in lung function measured by spirometry, FEV1, measured over 3 months.
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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 | No |
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
| 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 will be the last particpants final study contact, at 3 months follow up. |
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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 | |