Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

Understanding Inflammation, InFection and Interventions in Severe Exacerbations of Cystic Fibrosis

Sponsor: Alexander Horsley

NCT ID: NCT07484607

View on ClinicalTrials.gov ↗

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.

Cystic Fibrosis (CF)Cystic Fibrosis Pulmonary Exacerbation

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: 1. Confirmed diagnosis of cystic fibrosis (CF), defined as presence of two pathogenic CF-causing CFTR mutations AND clinical features consistent with a diagnosis of CF, OR presence of at least one pathogenic CF-causing CFTR mutation AND sweat chloride (before use of CFTR modulators) \>60mmol/L AND clinical features consistent with a diagnosis of CF. 2. Receiving care from a UK Adult Cystic Fibrosis Centre taking part in the study. 3. EITHER: • Have had at least 1 previous exacerbation of CF lung disease, treated with intravenous antibiotics, in the previous 12 months. OR • Enrolled in the CF-Tracker study (IRAS ID 338539) within the last 24 months (dated from date of completion of baseline Tracker visit) 4. In case of treatment for an exacerbation, likely to be treated with a ß-lactam or an anti-pseudomonal penicillin, combined with tobramycin or colistin, per CF Trust and NICE guidelines for 1st-line CF therapies. 5. Able to produce sputum (spontaneous or induced) at baseline visit. 6. Able to understand the patient information sheet, willing to consent to study protocol. Exclusion Criteria: 1. When attending for the baseline visit participants should be clinically stable at the time of the visit. This is defined as no acute change in their baseline symptoms or presence of new viral symptoms. They should not be on additional antibiotics or anti-viral therapies for any reason (above their usual medications), and should have completed any such additional therapies at least 4 weeks prior. 2. Extensive antibiotic allergies or intolerances that mean they could not be treated with standard CF antibiotic regimens, as outlined in section 5.6. 3. Subjects with infection with Mycobacteria tuberculosis 4. Subjects with active ABPA, defined as receiving treatment for ABPA currently or within the last 4 months, or those considered at risk of requiring treatment for ABPA in the next 12 months. 5. Subjects receiving long term oral steroids at an equivalent dose of 10mg or more per day of prednisolone. 6. Subjects receiving any other form of long term immune-suppressant therapy. 7. Subjects with non-tuberculous mycobacteria (NTM) infection who are undergoing active eradication therapy. Subjects with chronic NTM infection who are not on eradication therapy, and not expecting to start this within the next 12 months, are not excluded. 8. Any other condition, co-morbidity or other feature that, in the opinion of the investigator would render the subject unable to complete the protocol or unsuitable for inclusion. 9. Planning on participating in a clinical trial of a novel experimental investigational medical product in the next 12 months.

Where Is This Study? (6 UK sites)

Cardiff and Vale University Health Board

Cardiff CF14 4XW, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Jamie Duckers, MB BCH (Hons), MDPrincipal Investigator
Jamie Duckers, MB BCH (Hons), MD02920 715382Jamie.duckers@wales.nhs.uk

Royal Devon and Exeter Hospital (Wonford)

Exeter EX2 5DW, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Phillip MitchelmorePrincipal Investigator

Leeds Adult CF Centre

Leeds LS9 7TF, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Daniel Peckham, MBBS MRCP DM FRCPPrincipal Investigator
Daniel Peckham, MBBS MRCP DM FRCP07850070551d.g.peckham@leeds.ac.uk

Liverpool Heart & Chest Hospital

Liverpool L14 3PE, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Fredrick Frost, BMedSci, BMBS, MRCP(UK), MDPrincipal Investigator
Fredrick Frost, BMedSci, BMBS, MRCP(UK), MD0151 254 3427freddy.frost@lhch.nhs.uk

Manchester Adult Cystic Fibrosis Centre

Manchester M23 9LT, United Kingdom

Recruiting
Site contact (verified)
Peter BarryPrincipal Investigator
Alexander Horsley, MA MBChB MRCP PhD FERS0161 2912046alexander.horsley@manchester.ac.uk

Newcastle Adult CF Centre

Newcastle upon Tyne NE1 4LP, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Simon DoePrincipal Investigator

How to Get in Touch

Alexander Horsley, MA MBChB MRCP PhD FERS

Sponsor contact

CONTACT

01612915869 Alexander.horsley@manchester.ac.uk

Cheuk Ning Sharon Chau

Sponsor contact

CONTACT

01613060797 cheukningsharon.chau@manchester.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-10