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Understanding Inflammation, InFection and Interventions in Severe Exacerbations of Cystic Fibrosis
Sponsor: Alexander Horsley
Summary
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.
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2025-10-09
Completion Date
2029-12-31
Last Updated
2026-03-24
Healthy Volunteers
No
Locations (6)
Cardiff and Vale University Health Board
Cardiff, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom
Leeds Adult CF Centre
Leeds, United Kingdom
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom
Manchester Adult Cystic Fibrosis Centre
Manchester, United Kingdom
Newcastle Adult CF Centre
Newcastle upon Tyne, United Kingdom