UNIFIED-CF
Details
- Therapeutic approach
- Observational
- Trial status
- Open to recruitment Participating Centres
- Trials Tracker ID
- TT014805
- Last updated
- 12/11/2025
The UNIFIED-CF study: Understanding inflammation, infection and interventions in severe exacerbations of cystic fibrosis
Study detailsThe UNIFED study is a study to understand how people respond to treatment for exacerbations during illness and recovery. We define exacerbations as when people with cystic fibrosis (CF) experience worsening of chest symptoms, like cough, breathlessness and wheezing.
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 different things that occur in the body during an exacerbation and how/if they relate to different treatments.
The overall aim of the UNIFIED-CF study is to understand how the body responds to infection, how this differs between different people, and how antibiotics affect bugs and the body’s response to bugs, then we can identify why treatments work, and why sometimes they don’t work so well.
Participants will be asked to provide a sputum sample, blood, and two lung function tests and complete questionnaires at stable baseline visit. Participants also taking part in the CF-Tracker study will not need to repeat stable baseline testing for UNIFIED-CF, if they consent for their previous samples to be used.
If participants are admitted to hospital for treatment of an exacerbation, they will be asked to provide samples and complete questionnaires before they start treatment.
Participants will receive standard exacerbation treatment as chosen by their usual CF team. They will be asked to provide samples (including bloods, urine, sputum, nasal swabs, etc.) and symptom questionnaires typically three to five times (maximum of six), at different time points depending on the length of their hospital stay.
Participants will be asked to complete further tests and questionnaires remotely after they have been discharged, as well as to complete follow-up sampling and assessments 6-14 weeks later.
*Recruitment of up to 300 participants to get 125 participants for follow ups with exacerbations.
This study is part of the PULSE-CF Innovation Hub, co-funded by Cystic Fibrosis Trust and LifeArc. You can read more about PULSE-CF and the Translational Innovation Hub Network here.
- Phase
- Not applicable
- Length of participation
- Maximum of monitoring over 2 years. Participants that present with an exacerbation will be monitored during stay in hospital, up to a maximum of 17 days, and at follow-up 6-14 weeks later. After this follow-up visit there will be no further participation
- Recruitment target
- 125
- CF sponsor
- University of Manchester
- CF sponsor type
- Academic
Who can take part?
- Age range
- 16 years and older
- Including people
-
Confirmed diagnosis of cystic fibrosis (CF), under the care of one of the participating Adult CF Centres
-
Have had at least 1 previous exacerbation of CF lung disease, treated with intravenous antibiotics, in the previous 12 months.
-
- Excluding people
- On long term oral steroids (dose more than 10mg prednisolone per day) or on long term immune-suppressant therapy
- Infection with Mycobacteria tuberculosis
- Active Allergic Bronchopulmonary Aspergillosis, for which treatment is being given or considered
- Unable to produce sputum, spontaneous or induces, at baseline visit
- If the potential participant is normally able to produce sputum and still wishes to take part, visit 1 can be repeated on up to two additional occasions if this is needed to obtain sample