Cystic Fibrosis (CF)CF-TrackerNCT06940531
Identifying the Causes and Risk Factors of Pulmonary Exacerbations in Cystic Fibrosis
An observational study of Cystic Fibrosis (CF) and Cystic Fibrosis Pulmonary Exacerbation, run by Alexander Horsley at 18 sites in United Kingdom.
Trial summary
The CF-Tracker study is a community surveillance study, designed to understand the causes of exacerbations in people with cystic fibrosis (CF) (pwCF). These are episodes when pwCF become more unwell, typically characterised by increased cough, sputum, and breathlessness, and requiring prolonged courses of oral or… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis (CF), Cystic Fibrosis Pulmonary Exacerbation
- How many people
- 300 participants
- Where
- 18 sitesUnited Kingdom
- Study dates
- 16 May 2025to 31 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: United Kingdom
Who may be able to join
- For Adult Participants
- 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.
- Age ≥ 16 years and receiving care from a UK Adult Cystic Fibrosis Centre for main study. 5-16yrs for Paediatric pilot study (see below).
- Have had at least 1 previous exacerbation of CF lung disease, treated with oral or intravenous antibiotics, in the previous 12 months.
- Able to understand the patient information sheet, willing to consent to study protocol and to returning home samples
- Has a home spirometry device and able to use this
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- For those taking part in Group-B, additional inclusion criteria include
- Willing to attend for additional face to face visits at 4 weeks, 26 weeks, and if they become unwell
- For those taking part in home monitoring (as part of Group-B at Manchester)
- Has wireless internet at home
- Willing to allow to home access to set up monitoring devices, collect these back in at end of study, and to carry out other visits to perform calibration or intermittent home air sampling.
- For Paediatric Participants
- 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.
- Receiving care from an eligible Paediatric CF Centre.
- Age 5-16 years
- Have had at least 1 previous exacerbation of CF lung disease, treated with antibiotics.
- Able to understand the study and/or willing to assent to study protocol.
- Parents or guardians able to understand the study and willing to consent to take part, including helping with home sampling
- Has a home spirometry device and able to use this
- For Healthy Volunteers
- Healthy subject, male or female, aged 16-65 years
- No active lung condition, chronic inflammatory disorder or infection
- Not been on antibiotics or anti-inflammatory agents of any sort (including inhaled or systemic corticosteroids) for at least 90 days.
- No recent (defined as within the previous 4 weeks) acute viral symptoms
- Willing to sign the consent form and provide the samples.
Who cannot join
- Unable to produce sputum, spontaneous or induced, at visit 1. If subject 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 sputum sample.
- For the first 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 to visit 1.
- Subjects with infection with Mycobacteria tuberculosis
- Subjects with active ABPA, defined as receiving treatment for ABPA currently or within the last 12 months, or those considered at risk of requiring treatment for ABPA in the next 12 months.
- 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.
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- 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.
- Subjects who are unable to complete home spirometry who have previously been shown poor adherence to home monitoring requests
- 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.
- For home monitoring, any subject where the investigator or their team has concern about staff safety when performing home visits.
- Patients taking part in other long term trials or observational studies are eligible to take part in CF-Tracker. Local investigators should judge whether the burden of additional research visits will be manageable.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United Kingdom18 sites, 18 recruiting
- Not yet recruiting
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Joanna Whitehouse, Angela.Holden@uhb.nhs.uk
Gurcharan Singh, Gurcharan.singh@uhb.nhs.uk
- Not yet recruiting
Blackpool Teaching Hospitals
Blackpool, FY3 8NR
Tarek Saba, dr.saba@nhs.net
Mohamed Etumi, mohamed.etumi@nhs.net
- Not yet recruiting
Medical Research Unit, Bristol Royal Infirmary
Bristol, BS2 8HW
Nick Bell, 0117 342 9200, nick.bell@uhbw.nhs.uk
Sally Coplowe, 0117 342 9200, sally.coplowe@uhbw.nhs.uk
- Recruiting
Cardiff and Vale University Health Board
Cardiff, CF14 4XW
Jamie Duckers, MB BCH (Hons), MD, 02920 715382, Jamie.duckers@wales.nhs.uk
Katherine Cabasan-Rose, 02920 715510, katherine.cabasan-rose@wales.nhs.uk
- Recruiting
Royal Devon and Exeter Hospital (Wonford)
Exeter, EX2 5DW
Phillip Mitchelmore, 01392 40 6981, philip.mitchelmore@nhs.net
Sophie Whiteley, 01392 40 6981, s.whiteley1@nhs.net
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow, G51 4TF
Gordon macGregor, 0141 2327600, Gordon.macgregor@nhs.scot
Annie Husband, 0141 2327600, annie.husband@nhs.scot
- Recruiting
Leeds Adult CF Centre
Leeds, LS9 7TF
Daniel Peckham, MBBS MRCP DM FRCP, 07850070551, d.g.peckham@leeds.ac.uk
Helen Chadwick, helen.chadwick4@nhs.net
- Recruiting
Liverpool Heart & Chest Hospital
Liverpool, L14 3PE
Fredrick Frost, BMedSci, BMBS, MRCP(UK), MD, 0151 254 3427, freddy.frost@lhch.nhs.uk
Fredrick Frost, BMedSci, BMBS, MRCP(UK), MD
- Not yet recruiting
Chest Unit Reception, King's College Hospital
London, SE5 9RS
Michael Waller, m.waller@nhs.net
Melanie Le Sayec, melanie.lesayec@nhs.net
- Not yet recruiting
Royal Brompton Hospital, Department of Cystic Fibrosis (Adult)
London, SW3 6LL
Nicholas Simmonds, 020 7352 8121, N.Simmonds@rbht.nhs.uk
Yasmine Needham, 020 7352 8121, yasmine.needham1@nhs.net
- Recruiting
Manchester Adult Cystic Fibrosis Centre
Manchester, Manchester, M23 9LT
Alexander Horsley, MA MBChB MRCP PhD FERS, 0161 2912046, alexander.horsley@manchester.ac.uk
Natalie Hill, 07488 372 221, Natalie.Hill@mft.nhs.uk
- Not yet recruiting
Newcastle Adult CF Centre
Newcastle upon Tyne, NE1 4LP
Simon Doe, 0191 2824877, Simon.doe@nhs.net
Alan Anderson, alan.anderson8@nhs.net
- Not yet recruiting
Nottingham City Hospital
Nottingham, NG5 1PB
Helen Barr, helen.barr2@nhs.net
Tim Adcock, tim.adcock@nhs.net
- Not yet recruiting
John Radcliffe Hospital
Oxford, OX3 9DU
Nick Talbot, nicholas.talbot@ouh.nhs.uk
Nick Talbot
- Not yet recruiting
National Institute for Health Research Clinical Research Facility
Southampton, SO16 6YD
Mary Carroll, 023 8120 4989, Mary.Carroll@uhs.nhs.uk
Lorriane Hewitt, 023 8120 4989, Lorriane.hewitt@uhs.nhs.uk
- Not yet recruiting
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
Angela McGowan, Angela.McGowan@uhnm.nhs.uk
GILES FITCH, GILES.FITCH@uhnm.nhs.uk
- Recruiting
York Hull Adult Cystic Fibrosis Centre
York, YO31 8HE
Katy Lee, 01904 725 601, katy.lee3@nhs.net
Tracey Daniels, 01904 725601, traceydaniels1@nhs.net
- Recruiting
York Hull Adult Cystic Fibrosis Centre
York, YO31 8HE
Jamie Watkins, 01904 725 601, jamie.watkins@nhs.net
Tracey Daniels, 01904 725 601, traceydaniels1@nhs.net
About this study
The CF-Tracker study is a community surveillance study, designed to understand the causes of exacerbations in people with cystic fibrosis (CF) (pwCF). These are episodes when pwCF become more unwell, typically characterised by increased cough, sputum, and breathlessness, and requiring prolonged courses of oral or intravenous antibiotics.
This observational study applies a two-tiered approach over 12 months. It will recruit 200 pwCF to Group A, and an additional 100 pwCF to Group B, which follows the same format but includes additional in-clinic sampling.
Read more
Participants will provide longitudinal clinical data and biological samples. Group B will be offered at 5 specialist CF centres (Manchester, Cardiff, Newcastle, Leeds, Liverpool), will include additional sampling methods at clinic visits, and additional scheduled clinic visits at 1 month and 6 months. Group B participants will be offered an in-person visit if they become unwell, so that samples can be collected before they start antibiotics. In Group B, those attending the Manchester clinic will have the option of taking part in a 12 month home environmental and pollution monitoring, and sleep monitoring (both optional arms).
A pilot study will test the practicalities of running the same protocol in a paediatric population. This will consist of up to 25 children with CF (5-15 years) attending a paediatric clinic in one of the four core centres. Up to 40 healthy volunteers will be recruited to provide samples on a single occasion as controls.
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, www.pulse-cf.com). The aim of the Hub is that the data from CF-Tracker will support the delivery of a platform clinical trial to test exacerbation-prevention interventions in CF.
Read the detailed description
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.
There will be four separate cohorts of participant
- Group A participants will be 200 adults with CF (16 years or older) attending a UK adult CF centre taking part in the study
- Group B participants will be 100 additional adults with CF attending one of the five core CF adult centres: Manchester, Leeds, Newcastle, Cardiff, Liverpool.
- There will be a pilot study to test the practicalities of running the same protocol in a paediatric population. This will consist of up to 25 children with CF (5-16 years) attending a paediatric clinic in one of the five core centres.
- In addition, the investigators will recruit up to 40 healthy volunteers to provide samples on a single occasion as controls.
Group A participants will have a single in-person visit, at the start of the study. Clinical data, including lung function (spirometry), venous blood draw, sweat chloride, saliva sample and finger-prick dried blood spot sample, sputum, nasal liquid sample and urine sample and demographic data will be collected. The study will run for 12 months. Home sampling kit, consisting of 13 home sampling boxes and 3 additional exacerbation boxes, will be provided for participants to collect in-home sampling for the first 6 months fortnightly. The 3 additional exacerbation boxes will be provided for posting additional set of samples when unwell. There will be questionnaires to complete to remotely monitor the adherence to the protocol. Study app ("Watson") will be set up to provide reminders and aid study adherence and timely return of samples.
Group B will only be offered at 5 specialist CF centres (Manchester, Cardiff, Newcastle, Leeds, Liverpool). This follows the same format as Group A but includes additional face to face visits at 1 and 6 months, and the invitation to return for additional samples if unwell. In Group B, those attending the Manchester clinic will have the option of taking part in a 12 month home environmental and pollution monitoring and sleep monitoring (both optional arms).
The investigators will include an additional feasibility cohort of up to 25 paediatric patients (aged 5-15 years). This will open in up to 4 centres who are already running the adult study. The basic study protocol will be the same as for Group A, with a single patient visit at the start of the study and the remainder of the assessments from home monitoring. Parental consent, participant consent and assent will be obtained.
In order to ensure that the investigators have reference values for some of the established and experimental biomarkers, the investigators will also collect samples from 40 healthy volunteers on a single occasion. Visits will take place at CRFs and are planned for the Manchester site only. Clinical samples, including sputum, venous blood draw, nose and throat swabs, FeNo, VOCs and nasal liquid, and demographic information will be collected.
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 200 adults with CF (16 years or older) will be recruited to Group A. Group A participants will have a single in-person visit, at the start of the study. Clinical data, including lung function (spirometry), venous blood draw, sweat chloride, saliva sample and finger-prick dried blood spot sample, sputum, nasal liquid sample and urine sample and demographic data will be collected. The study will run for 12 months. Home sampling kit, consisting of 13 home sampling boxes and 3 additional exacerbation boxes, will be provided for participants to collect in-home sampling for the first 6 months fortnightly. The 3 additional exacerbation boxes will be provided for posting additional set of samples when unwell. There will be questionnaires to complete to remotely monitor the adherence to the protocol. The study app will be set up to provide reminders and aid study adherence and timely return of samples. | |
| Group B | 100 adults with CF (16 years or older) will be recruited to Group B. Group B will only be offered at 5 specialist CF centres (Manchester, Cardiff, Newcastle, Leeds, Liverpool). This follows the same format as Group A but includes additional face to face visits at 1 and 6 months, and the invitation to return for additional samples if unwell. In Group B, those attending the Manchester clinic will have the option of taking part in a 12 month home environmental and pollution monitoring and sleep monitoring (both optional arms). | |
| Paediatric Pilot Study | An additional feasibility cohort of up to 25 paediatric patients (aged 5-15 years) will be included. This will open in up to 4 centres who are already running the adult study. The basic study protocol will be the same as for Group A, with a single patient visit at the start of the study and the remainder of the assessments from home monitoring. Parental consent, participant consent and assent will be obtained. | |
| Healthy Volunteers | 40 healthy volunteers will be recruited to ensure that the investigators have reference values for some of the established and experimental biomarkers. Clinical samples, including sputum, venous blood draw, nose and throat swabs, FeNo, VOCs and nasal liquid, and demographic information will be collected on a single occasion. Visits will take place at CRFs and are planned for the Manchester site only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first exacerbation
Time (in days) to first exacerbation treated with oral or intravenous antibiotics is the primary outcome against which inflammatory marker data will be assessed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start16 May 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexander Horsley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Horsley, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940531
- Sponsor's protocol ID
- 338539
- Acronym
- CF-Tracker
- Status last verified
- May 2025
- First submitted
- 1 Apr 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once collected and full anonymised, data will be made open to share based on FAIR data principles. Access to emerging datasets, or parts of datasets, is also possible based on a Data Access Application to the study team, which will be reviewed by the steering commitee.