Treating pulmonary fibrosis with co-trimoxazole
Research type
Research Study
Full title
The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary Fibrosis with the Addition of Co-trimoxazole (EME-TIPAC)
IRAS ID
146057
Contact name
Andrew Wilson
Contact email
Sponsor organisation
Norfolk and Norwich University Hospital
Eudract number
2014-004058-32
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Pulmonary fibrosis is a condition with limited treatment options. In a previous study we showed that people with pulmonary fibrosis who regularly took an antibiotic (called co-trimoxazole) were 5 times more likely to be alive after one year than those that didn’t. However, treatments for pulmonary fibrosis have now changed and we are trying to find out if co-trimoxazole is still as effective. We want to know whether co-trimoxazole, when given alongside current treatments, improves life expectancy and/or reduces the chances of being admitted to hospital for people with pulmonary fibrosis and, by measuring biomarkers (see below, how it may be working. We are aiming to recruit 330 participants from different regions throughout the UK. All patients must have some degree of breathlessness and reduced breathing tests and not have major health problems, problems with their liver or kidneys. After completing initial assessments and safety blood tests, participants will be randomised to receive either co-trimoxazole 960mg twice daily or a placebo tablet for between 1 year and 3.5 years depending on when they start the study. We will record the time until either a participant is admitted to hospital, has a lung transplant or dies. Questionnaires, breathing tests and blood for biomarkers (chemicals that allow us to understand about pulmonary fibrosis) will be completed or taken after 3 months, 6 months then every 6 months until the study ends. Patients will be invited to provide a blood sample for genetic testing. Fifty patients will be invited to have a bronchoscopy (lung camera test) to find out if co-trimoxazole has an effect on the numbers or amount of inflammatory cells, biomarkers and bacteria (using traditional and new techniques). It is hoped that this study will confirm whether co-trimoxazole has a benefit for patients and, if so, how it may be working.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/1800
Date of REC Opinion
24 Nov 2014
REC opinion
Further Information Favourable Opinion