A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-2 in lung transplant recipients.
Clinical Trials Unit, Rigshospitalet
Duration of Study in the UK
1 years, 10 months, days
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.
North East - Tyne & Wear South Research Ethics Committee
Date of REC Opinion
6 Jan 2015
Further Information Favourable Opinion