Extrait

Background and study aims Pulmonary fibrosis is a rare and poorly understood health condition that is caused by scarring of the lungs. It causes a person to become short of breath when physically active and develop a dry, persistent, cough. It gets worse over time and is often fatal. There is no cure for the condition and treatments given are generally palliative. These include giving patients oxygen though a mask, drug treatments (such as pirfenidone) and, in some cases, a lung transplant may be an option. A previous study has 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 so researchers now want to see if co-trimoxazole is still as effective. They 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. Who can participate? Pulmonary fibrosis patients 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. What does the study involve? After completing initial assessments and safety blood tests, participants are randomly allocated into one of two groups. Those in group 1 are given co-trimoxazole 960mg twice a day for between 1 year and 3.5 years depending on when they start the study. Those in group 2 are given a placebo tablet for a similar time period. The time until either a participant is admitted to hospital, has a lung transplant or dies is recorded. Questionnaires, breathing tests and blood for biomarkers (chemicals that allow researchers to understand about pulmonary fibrosis) are completed or taken after 3 months, 6 months then every 6 months until the study ends. Patients are also invited to provide a blood sample for genetic testing. Fifty patients are 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. What are the possible benefits and risks of participating? Patients may not receive active trial treatment, and may receive the dummy treatment (placebo) but patients will be able to receive any other approved treatment for pulmonary fibrosis from their doctor. Patients may be required to attend the hospital on visits in addition to routine clinic visits for the trial however travel expenses for these will be reimbursed. Blood tests may cause discomfort and bruising. The questionnaires will take time to complete. The breathing tests may cause slight breathlessness, difficulty breathing or chest discomfort for a few minutes at the most. Patients may experience side-effects listed in the protocol. In addition, its not guaranteed that the study will help patients but the information collected from this study will improve health care professionals ability to treat patients with pulmonary fibrosis in the future. Where is the study run from? 40 UK NHS hospitals (lead site - Norfolk and Norwich University Hospitals NHS Foundation Trust) When is the study starting and how long is it expected to run for? December 2014 to December 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Mr Matt Hammond

Critère d'inclusion

• Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory

Liens

• isrctn
• ictrp