Identifying the Causes and Risk Factors of Pulmonary Exacerbations in Cystic Fibrosis
The CF-Tracker study aims to understand what causes 'exacerbations' – or flare-ups – in people with cystic fibrosis (CF). These are times when CF symptoms worsen, often needing antibiotics. The study will follow adults with CF for 12 months, collecting health information and samples to learn more. A smaller group will have extra clinic visits and tests. There's also a pilot study for children with CF, and healthy volunteers will provide samples as a comparison. The findings from this study could help researchers develop new ways to prevent these flare-ups, ultimately improving the health and well-being of people living with CF. It's a big step towards better understanding and managing CF.
At a glance
What is this study about?
The CF-Tracker study is a really important project looking into cystic fibrosis (CF) and those frustrating times when symptoms suddenly get worse, often called 'exacerbations' or 'flare-ups'. If you have CF, you'll know these flare-ups can mean more coughing, more phlegm, and feeling more breathless, often leading to a course of antibiotics, either by mouth or through a drip. This study wants to find out exactly what triggers these flare-ups so we can work out better ways to prevent them from happening in the future.
The researchers will follow people with CF for a year, gathering information about their health and collecting different types of samples. This 'observational' study just means they'll be watching and collecting data, not giving new treatments. There are two main groups for adults: Group A, with 200 participants, who will mostly provide samples and information from home. Group B, with 100 participants, will do something similar but will also have extra visits to a CF clinic and, if they become unwell, may be asked to come in for samples before they start antibiotics.
There's also a small pilot study for children with CF (aged 5-16) to see if this type of research works well for them. In addition, some healthy volunteers will provide samples once, to give the researchers something to compare against. The information gathered from CF-Tracker is a key part of a bigger research effort, aiming to create better ways to prevent flare-ups and improve the lives of people with CF. This study is funded by the Cystic Fibrosis Trust, showing how important it is.
Key takeaways
- Aims to understand why CF flare-ups happen.
- Mainly for adults with CF, with a pilot for children.
- Involves providing health information and various samples over 12 months.
- Does not change your current CF treatment.
- Findings could help prevent future CF flare-ups.
- Participation includes home-based and/or clinic-based activities.
Who may be eligible?
This study is mainly looking for adult volunteers with cystic fibrosis (CF), aged 16 or older, who receive their care at a UK adult CF clinic. To be included, you would need to have had at least one flare-up in your CF lung disease in the last 12 months that required antibiotics. You also need to be able to understand the study information and be happy to provide samples from home.
If you're interested in joining Group B, which involves more clinic visits, you'd need to be able to attend one of five specific CF centres: Manchester, Leeds, Newcastle, Cardiff, or Liverpool. If you're at the Manchester clinic and interested in extra home monitoring, you'll need home internet and be willing to have devices set up in your home.
There's also a small number of places for children with CF, aged 5-16, attending a paediatric clinic at one of the main study centres. Like adults, they would need a confirmed CF diagnosis and to have had a flare-up in the past. Parents or guardians would need to understand and agree for their child to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have a confirmed diagnosis of cystic fibrosis?
- Am I 16 years old or older? (Or 5-16 for the children's pilot)
- Have I had at least one CF lung flare-up needing antibiotics in the last year?
- Am I able to understand the study information and collect samples from home?
- If interested in Group B, can I attend one of the five main study clinics?
- If at Manchester Group B and interested, do I have home internet for monitoring?
What does participation involve?
If you join Group A, you'll have one visit to your clinic at the very beginning of the study. During this visit, you'll provide some general health information, have some lung function tests, and give samples like blood, saliva, and urine. You'll then be given kits to collect samples at home every two weeks for the first six months. There will also be extra kits to use if you have a flare-up. You'll complete questionnaires and use a study app called "Watson" to help you remember when to send samples.
If you join Group B, you'll do everything in Group A, but you'll also have extra visits to your clinic at 1 month and 6 months. If you start to feel unwell, you might be asked to come in for an extra unplanned visit to provide samples before you start any antibiotics. If you're in Group B at the Manchester clinic, you might also have the option to take part in additional home monitoring for air quality and sleep for 12 months.
The study will last for 12 months for all participants. Your involvement doesn't change your usual CF care or medication. For children in the pilot study, the involvement would be similar to Group A but adapted for younger participants. There are also specific opportunities for healthy volunteers to provide samples just once.
Potential risks and benefits
Locations (18)
- Manchester Adult Cystic Fibrosis CentreVerified postcodeManchester, United Kingdom· Recruiting
- Birmingham Heartlands HospitalVerified postcodeBirmingham, United Kingdom· Not yet recruiting
- Blackpool Teaching HospitalsVerified postcodeBlackpool, United Kingdom· Not yet recruiting
- Medical Research Unit, Bristol Royal InfirmaryVerified postcodeBristol, United Kingdom· Not yet recruiting
- Cardiff and Vale University Health BoardVerified postcodeCardiff, United Kingdom· Recruiting
- Royal Devon and Exeter Hospital (Wonford)Verified postcodeExeter, United Kingdom· Recruiting
- NHS Greater Glasgow and ClydeVerified postcodeGlasgow, United Kingdom· Recruiting
- Leeds Adult CF CentreVerified postcodeLeeds, United Kingdom· Recruiting
- Liverpool Heart & Chest HospitalVerified postcodeLiverpool, United Kingdom· Recruiting
- Chest Unit Reception, King's College HospitalVerified postcodeLondon, United Kingdom· Not yet recruiting
- Royal Brompton Hospital, Department of Cystic Fibrosis (Adult)Verified postcodeLondon, United Kingdom· Not yet recruiting
- Newcastle Adult CF CentreVerified postcodeNewcastle upon Tyne, United Kingdom· Not yet recruiting
Common questions
What is an 'exacerbation' in CF?
An exacerbation, or flare-up, is when CF symptoms like cough, phlegm, and breathlessness get worse, often needing antibiotics.
How long will I be involved in the study?
The study will last for 12 months for all participants, though your direct involvement, like home sampling, might be for a shorter period.
Will taking part change my usual CF treatment?
No, this is an observational study, meaning it won't change your regular care or the medications you take for your CF.
Do I need to live near one of the study centres?
If you're in Group A, you don't need to. If you're in Group B, or the children's pilot, you'd need to be able to attend one of the five specific CF centres (Manchester, Cardiff, Newcastle, Leeds, Liverpool).
Who is funding this research?
The study is funded by the Cystic Fibrosis Trust, a leading charity supporting people with CF.
How to find out more
Alexander Horsley, MA MBChB MRCP PhD FERS
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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