The UNIFIED-CF Study
Research type
Research Study
Full title
The UNIFIED-CF Study: Understanding Inflammation, Infection and Interventions in Severe Exacerbations of Cystic Fibrosis
IRAS ID
338540
Contact name
Alex Horsley
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
4 years, 6 months, 30 days
Research 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, we 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, we 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.
REC name
East of England - Essex Research Ethics Committee
REC reference
25/EE/0066
Date of REC Opinion
23 Apr 2025
REC opinion
Further Information Favourable Opinion