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EPOS Trial

  • Research type

    Research Study

  • Full title

    A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-2 in lung transplant recipients.

  • IRAS ID

    164296

  • Contact name

    James Lordan

  • Contact email

    jim.lordan@nuth.nhs.uk

  • Sponsor organisation

    Clinical Trials Unit, Rigshospitalet

  • Eudract number

    2014-002022-12

  • Clinicaltrials.gov Identifier

    NCT02262299

  • Duration of Study in the UK

    1 years, 10 months, days

  • Research summary

    This study is initiated and managed by respiratory disease physicians to look at the effect of Pirfenidone on lung transplant patients who have developed Bronchiolitis Obliterans Syndrome (BOS). This disease is an indicator that the lung transplant is being rejected, as the airways become scarred and narrowed and breathing becomes difficult. Pirfenidone is currently approved for use in Europe for another lung disease, idiopathic pulmonary fibrosis (IPF) which has similar symptoms to BOS. It is hoped that Pirfenidone will help to relieve the breathing difficulties in patients with BOS. There are 11 lung transplant centres that will take part to recruit 80 patients who have had a double lung transplant. Patients will be randomized to receive either drug or placebo and will take 6 months of treatment. Both the physicians and patients will be blind to the treatment group. All tests performed during this study are routine for this group of patients and consist of lung function tests, blood tests and a 6 minute walk test. In addition, patients will receive the currently accepted treatment for BOS which is Azithromycin. There will be a study specific health questionnaire that is done at the beginning and end of the study. Patients will come back to the clinic once a month for the first 4 months and then again after 6 months; this is in accordance with routine practice. There will be a data safety monitoring board (DSMB) to review the safety of the patients during the study. The steering committee, which consists of 5 respiratory disease experts, has designed the study and will review all patients enrolled in the study to ensure they fit the study criteria. This committee will be responsible for the analysis of the results and any publication.

  • REC name

    North East - Tyne & Wear South Research Ethics Committee

  • REC reference

    14/NE/1221

  • Date of REC Opinion

    6 Jan 2015

  • REC opinion

    Further Information Favourable Opinion