Condition: Cystic Fibrosis (CF) · Cystic Fibrosis Pulmonary Exacerbation · Sponsor: Alexander Horsley
The UNIFIED-CF study is an observational study designed to investigate the impacts of treatment given for severe pulmonary exacerbations in people living with cystic fibrosis (pwCF). Exacerbations are episodes when pwCF become more unwell, typically characterised by increased cough, sputum, and breathlessness and treated with a combination of oral and/or intravenous antibiotics. Severe exacerbations require treatment with intravenous antibiotics and impart considerable morbidity on pwCF. In this study, the investigators will recruit people at risk of severe CF exacerbations when they are well and if/when they are subsequently admitted for treatment of an exacerbation, the investigators will track symptoms and lung function during recovery, and collect blood, sputum and stool samples to allow us to explore the biological mechanisms of exacerbations and how they relate to different treatment responses. The study is event driven and will complete recruitment once 125 participants have completed treatment and follow-up for a severe exacerbation event. This study is funded by the Cystic Fibrosis Trust. This study is part of a wider programme of research, led by the PULSE-CF Innovation Hub (and hosted by the University of Manchester). The aim of the Hub is that the data from the UNIFIED-CF study will ultimately support the design of a platform clinical trial to test exacerbation-prevention interventions in CF.
This description comes directly from the study's public registry record.
Alexander Horsley, MA MBChB MRCP PhD FERS · 01612915869 · Alexander.horsley@manchester.ac.uk
Cheuk Ning Sharon Chau · 01613060797 · cheukningsharon.chau@manchester.ac.uk
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| Cardiff and Vale University Health Board | Cardiff, United Kingdom | Not Yet Recruiting |
| Royal Devon and Exeter Hospital (Wonford) | Exeter, United Kingdom | Not Yet Recruiting |
| Leeds Adult CF Centre | Leeds, United Kingdom | Not Yet Recruiting |
| Liverpool Heart & Chest Hospital | Liverpool, United Kingdom | Not Yet Recruiting |
| Manchester Adult Cystic Fibrosis Centre | Manchester, United Kingdom | Recruiting |
| Newcastle Adult CF Centre | Newcastle upon Tyne, United Kingdom | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07484607