At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2025-10-09
- Last checked
- 2025-10
Plain English Summary
What is this study?
- • Testing a new treatment for cystic fibrosis (cf)
- • Clinical study - 200 participants
- • 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)
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with cystic fibrosis (cf)
Where?
- • Cardiff - Cardiff and Vale University Health Board
- • Exeter - Royal Devon and Exeter Hospital (Wonford)
- • Leeds - Leeds Adult CF Centre
- • Liverpool - Liverpool Heart & Chest Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Participants will be recruited by staff within the care of UK CF centres. Initial discussions will occur either during routine outpatient reviews, telephone consultations or during admissions. Consent will take place prior to any other procedures. The investigators will provide the option of re-using baseline stable visits from the CF-Tracker study as stable visits for the UNIFIED-CF study. Consent to do this is specifically taken in UNIFIED, the investigators have added this as an option, and participants can opt to repeat the visit. Participants will be people living with cystic fibrosis being cared for at a participating centre in the UK. The study will enrol only those who are considered to be at risk for severe exacerbation in the next 24 months. Up to 300 participants will be recruited across 6 sites (expected number needed to get 125 exacerbations = 200). Participants will be assessed during a period of clinical stability. Participants taking part in another hub study (CF-Tracker, IRAS: 338539) where the same data and samples are being collected will not need to repeat this visit and will be given the option of re-using the outcomes from the previous visit, or participants can also opt to repeat the visit. If a participant has had a stable baseline visit but has not undergone any eligible CF exacerbations, they will be monitored for two years. They will be invited to a second stable baseline visit to repeat the same measurements after 12 months (range 10-14 months). If participants are admitted to one of the participating CF units for treatment of a pulmonary exacerbation, they will be eligible to take part in the Exacerbation Treatment arm of the UNIFIED study and will be monitored during their admission for up to a maximum of 17 days. In this arm, participants will undergo repeated assessments at pre-specified timepoints before and during their treatment at Pre-IV antibiotic baseline, Day 3 (range = day 2-4), Day 7 (range = day 6-8), Day 10 (range = day 9-12) and discharge day, alongside standard clinical care. A follow-up visit will take place after 6-14 weeks once the participant has returned to clinical stability. After this follow-up visit their will be no further participation.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓Receiving care from a UK Adult Cystic Fibrosis Centre taking part in the study.
- ✓EITHER:
- ✓Have had at least 1 previous exacerbation of CF lung disease, treated with intravenous antibiotics, in the previous...
- ✓Enrolled in the CF-Tracker study (IRAS ID 338539) within the last 24 months (dated from date of completion of...
- ✓Able to produce sputum (spontaneous or induced) at baseline visit.
Who cannot take part
- ✗Extensive antibiotic allergies or intolerances that mean they could not be treated with standard CF antibiotic...
- ✗Subjects with infection with Mycobacteria tuberculosis
- ✗Subjects with active ABPA, defined as receiving treatment for ABPA currently or within the last 4 months, or those...
- ✗Subjects receiving long term oral steroids at an equivalent dose of 10mg or more per day of prednisolone.
- ✗Subjects receiving any other form of long term immune-suppressant therapy.
See the full criteria
Where Is This Study? (6 UK sites)
Cardiff and Vale University Health Board
Cardiff CF14 4XW, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter EX2 5DW, United Kingdom
Leeds Adult CF Centre
Leeds LS9 7TF, United Kingdom
Liverpool Heart & Chest Hospital
Liverpool L14 3PE, United Kingdom
Manchester Adult Cystic Fibrosis Centre
Manchester M23 9LT, United Kingdom
Newcastle Adult CF Centre
Newcastle upon Tyne NE1 4LP, United Kingdom
How to Get in Touch
Alexander Horsley, MA MBChB MRCP PhD FERS
Sponsor contactCONTACT
Cheuk Ning Sharon Chau
Sponsor contactCONTACT
