RecruitingOBSERVATIONAL

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

The UNIFIED-CF study is looking at how severe flare-ups, called exacerbations, are treated in people living with cystic fibrosis (CF). These flare-ups make people feel much worse, with increased cough and breathlessness, and usually need intravenous (IV) antibiotics. Researchers want to understand why these flare-ups happen, how they respond to different treatments, and how people recover. They will recruit people at risk of these severe flare-ups when they are feeling well. If a flare-up occurs and they are admitted to hospital, researchers will then track their progress, symptoms, and lung function during recovery. They will also collect blood, phlegm (sputum), and stool samples to explore the body's response to treatment. This information will help design better future treatments to prevent CF exacerbations.

At a glance

Status

Recruiting

Sponsor

Alexander Horsley

Enrolment target

200

Start

09 Oct 2025

Estimated completion

31 Dec 2029

Cystic Fibrosis (CF)Cystic Fibrosis Pulmonary Exacerbation

What is this study about?

The UNIFIED-CF study is all about understanding severe flare-ups, known medically as 'exacerbations', in people who have cystic fibrosis (CF). When someone with CF has an exacerbation, they feel much more unwell than usual, often experiencing a worse cough, more phlegm, and breathlessness. These severe flare-ups require treatment with strong antibiotics given directly into a vein (intravenously) and can be quite debilitating.

The main goal of this study is to explore the underlying reasons why these flare-ups occur and why different people respond to treatments in various ways. To do this, researchers will first invite people who are at risk of severe CF exacerbations to join the study when they are feeling well. If, during the study period, a participant is admitted to hospital for a severe CF exacerbation, the research team will carefully monitor their symptoms and how well their lungs are working throughout their recovery. They will also collect samples of blood, phlegm, and stool. By looking at these samples, they hope to uncover the biological processes happening in the body during an exacerbation and how these relate to treatment effectiveness. This information is crucial for developing more effective ways to manage and prevent these serious flare-ups in the future.

Key takeaways

Aims to understand severe CF flare-ups and treatment responses.
Observational study – no new experimental treatments.
Involves tracking symptoms, lung function, and collecting samples.
Participants are recruited when well, then monitored if an exacerbation occurs.
Funded by the Cystic Fibrosis Trust to improve future CF care.
You can withdraw at any time without affecting your medical care.

Who may be eligible?

To join the UNIFIED-CF study, you need to have a confirmed diagnosis of cystic fibrosis and be looked after at one of the participating CF centres in the UK. Crucially, you should be someone considered to be at risk of having a severe CF flare-up needing intravenous antibiotics within the next two years. This generally means you've had at least one such flare-up in the past year, or you are already part of another study called CF-Tracker.

When you first join the study, you'll need to be feeling well and stable, meaning no recent acute changes in your symptoms, no new viral infections, and you shouldn't have taken any extra antibiotics or anti-viral medications (beyond your usual ones) for at least four weeks prior. You should not have certain other conditions like active tuberculosis or a severe allergy that prevents you from taking standard CF antibiotics.

You also need to be able to understand the study information and be willing to give your consent to take part. You should also be able to produce some phlegm (spontaneously or with effort) for samples.

Quick self-check

I have been diagnosed with cystic fibrosis.
I receive care from a UK Adult CF Centre taking part in the study.
I have had at least one severe CF flare-up needing IV antibiotics in the past year, OR I am in the CF-Tracker study.
I am generally feeling well and stable right now (no recent infections or changes in medication).
I can produce some phlegm (spontaneously or with effort).
I am able to understand the study information and want to take part.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have an initial visit when you are feeling well and stable. This might happen during a regular clinic appointment or even a phone call. During this visit, we will discuss the study in detail and obtain your consent. If you're already in the CF-Tracker study, you might not need to repeat some of the initial assessments.

After this, you'll be monitored for up to two years. If you experience a severe CF flare-up during this time and are admitted to hospital for treatment, you'll enter the second part of the study. During your hospital stay (up to 17 days), you'll undergo repeated assessments at specific times before and during your IV antibiotic treatment. These assessments will involve checking your symptoms, lung function, and collecting blood, phlegm, and stool samples. There is no new medication given as part of this study; all treatments will be prescribed by your usual medical team according to standard care. After your hospital stay, the research team will follow up on your recovery.

Potential risks and benefits

By taking part in this study, you could contribute valuable information that helps us better understand and treat severe CF flare-ups, potentially leading to improved care for all people with CF in the future. There are no significant direct medical risks beyond those involved in routine hospital care for your CF exacerbation, and the sample collections are generally well-tolerated. You will need to commit some time to visits and sample collection. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Cardiff and Vale University Health Board
Cardiff, United Kingdom· Not yet recruiting
Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom· Not yet recruiting
Leeds Adult CF Centre
Leeds, United Kingdom· Not yet recruiting
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom· Not yet recruiting
Manchester Adult Cystic Fibrosis Centre
Manchester, United Kingdom· Recruiting
Newcastle Adult CF Centre
Newcastle upon Tyne, United Kingdom· Not yet recruiting

Common questions

What is an 'exacerbation'?

An exacerbation is a medical term for a flare-up of your cystic fibrosis symptoms, making you feel much worse than usual, often needing extra treatment like intravenous antibiotics.

Will I receive any new medications in this study?

No, this study does not involve giving new medications. You will receive all your usual care and treatments as prescribed by your medical team.

What kind of samples will be collected?

Researchers will collect samples of your blood, phlegm (sputum), and stool (poo) at different times during the study.

How long will I be involved in the study?

You will be monitored for up to two years initially. If you have an exacerbation, you'll be monitored during your hospital stay (up to 17 days) and during recovery afterwards.

Who is funding this research?

This study is funded by the Cystic Fibrosis Trust, a charity dedicated to improving the lives of people with CF.

How to find out more

Alexander Horsley, MA MBChB MRCP PhD FERS

Alexander.horsley@manchester.ac.uk 01612915869 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.