Identifying the Causes and Risk Factors of Pulmonary Exacerbations in Cystic Fibrosis
CF-Tracker
1 other identifier
observational
300
1 country
18
Brief 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 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 23, 2025
CompletedStudy Start
First participant enrolled
May 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
March 19, 2026
May 1, 2025
4.6 years
April 1, 2025
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 months
Study Arms (4)
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.
Eligibility Criteria
United Kingdom
You may qualify if:
- 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
- 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.
- +9 more criteria
You may not qualify if:
- 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.
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Manchester Adult Cystic Fibrosis Centre
Manchester, Manchester, M23 9LT, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Blackpool Teaching Hospitals
Blackpool, FY3 8NR, United Kingdom
Medical Research Unit, Bristol Royal Infirmary
Bristol, BS2 8HW, United Kingdom
Cardiff and Vale University Health Board
Cardiff, CF14 4XW, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, EX2 5DW, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G51 4TF, United Kingdom
Leeds Adult CF Centre
Leeds, LS9 7TF, United Kingdom
Liverpool Heart & Chest Hospital
Liverpool, L14 3PE, United Kingdom
Chest Unit Reception, King's College Hospital
London, SE5 9RS, United Kingdom
Royal Brompton Hospital, Department of Cystic Fibrosis (Adult)
London, SW3 6LL, United Kingdom
Newcastle Adult CF Centre
Newcastle upon Tyne, NE1 4LP, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
National Institute for Health Research Clinical Research Facility
Southampton, SO16 6YD, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
York Hull Adult Cystic Fibrosis Centre
York, YO31 8HE, United Kingdom
York Hull Adult Cystic Fibrosis Centre
York, YO31 8HE, United Kingdom
Related Links
Biospecimen
* Spirometry * Impulse oscillometry * Venous blood draw * Saliva sample * Sputum sample * Cough swab * Urine Sample * Nose and throat swab * Exhaled volatiles (VOCs) * Exhaled nitric oxide (FeNO) * Nasal liquid sample * Rectal swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Respiratory Medicine and Honorary Consultant
Study Record Dates
First Submitted
April 1, 2025
First Posted
April 23, 2025
Study Start
May 16, 2025
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
March 19, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Details to be decided, but plan would be to make complete datasets open access.
- Access Criteria
- Data access is by application to the Steering Committee. For details on how to apply please email the study coordinator or PI
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.