Identifying the Causes and Risk Factors of Pulmonary Exacerbations in Cystic Fibrosis (CF-Tracker)

March 16, 2026 updated by: Alexander Horsley

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.

Study Overview

Status

Recruiting

Conditions

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

  1. Group A participants will be 200 adults with CF (16 years or older) attending a UK adult CF centre taking part in the study
  2. Group B participants will be 100 additional adults with CF attending one of the five core CF adult centres: Manchester, Leeds, Newcastle, Cardiff, Liverpool.
  3. 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.
  4. 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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
      • Blackpool, United Kingdom, FY3 8NR
      • Bristol, United Kingdom, BS2 8HW
        • Not yet recruiting
        • Medical Research Unit, Bristol Royal Infirmary
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nick Bell
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • Cardiff And Vale University Health Board
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jamie Duckers, MB BCH (Hons), MD
      • Exeter, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon and Exeter Hospital (Wonford)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Phillip Mitchelmore
      • Glasgow, United Kingdom, G51 4TF
        • Recruiting
        • NHS Greater Glasgow and Clyde
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gordon macGregor
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Adult CF Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Peckham, MBBS MRCP DM FRCP
      • Liverpool, United Kingdom, L14 3PE
        • Recruiting
        • Liverpool Heart & Chest Hospital
        • Contact:
        • Principal Investigator:
          • Fredrick Frost, BMedSci, BMBS, MRCP(UK), MD
      • London, United Kingdom, SE5 9RS
        • Not yet recruiting
        • Chest Unit Reception, King's College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Waller
      • London, United Kingdom, SW3 6LL
        • Not yet recruiting
        • Royal Brompton Hospital, Department of Cystic Fibrosis (Adult)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicholas Simmonds
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Not yet recruiting
        • Newcastle Adult CF Centre
        • Principal Investigator:
          • Simon Doe
        • Contact:
        • Contact:
      • Nottingham, United Kingdom, NG5 1PB
      • Oxford, United Kingdom, OX3 9DU
        • Not yet recruiting
        • John Radcliffe Hospital
        • Contact:
        • Principal Investigator:
          • Nick Talbot
      • Southampton, United Kingdom, SO16 6YD
        • Not yet recruiting
        • National Institute for Health Research Clinical Research Facility
        • Principal Investigator:
          • Mary Carroll
        • Contact:
        • Contact:
      • Stoke-on-Trent, United Kingdom, ST4 6QG
      • York, United Kingdom, YO31 8HE
        • Recruiting
        • York Hull Adult Cystic Fibrosis Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jamie Watkins
    • Manchester
      • Manchester, Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Manchester Adult Cystic Fibrosis Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexander Horsley, MA MBChB MRCP PhD FERS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

United Kingdom

Description

Inclusion Criteria:

For Adult Participants

  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. Age ≥ 16 years and receiving care from a UK Adult Cystic Fibrosis Centre for main study. 5-16yrs for Paediatric pilot study (see below).
  3. Have had at least 1 previous exacerbation of CF lung disease, treated with oral or intravenous antibiotics, in the previous 12 months.
  4. Able to understand the patient information sheet, willing to consent to study protocol and to returning home samples

  5. Has a home spirometry device and able to use this

    For those taking part in Group-B, additional inclusion criteria include

  6. 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)

  7. Has wireless internet at home
  8. 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

  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 an eligible Paediatric CF Centre.
  3. Age 5-16 years
  4. Have had at least 1 previous exacerbation of CF lung disease, treated with antibiotics.
  5. Able to understand the study and/or willing to assent to study protocol.
  6. Parents or guardians able to understand the study and willing to consent to take part, including helping with home sampling
  7. Has a home spirometry device and able to use this

For Healthy Volunteers

  1. Healthy subject, male or female, aged 16-65 years
  2. No active lung condition, chronic inflammatory disorder or infection
  3. Not been on antibiotics or anti-inflammatory agents of any sort (including inhaled or systemic corticosteroids) for at least 90 days.
  4. No recent (defined as within the previous 4 weeks) acute viral symptoms
  5. Willing to sign the consent form and provide the samples.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Subjects with infection with Mycobacteria tuberculosis
  4. 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.
  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. Subjects who are unable to complete home spirometry who have previously been shown poor adherence to home monitoring requests
  9. 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.
  10. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first exacerbation
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexander Horsley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 338539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Details to be decided, but plan would be to make complete datasets open access.

IPD Sharing Access Criteria

Data access is by application to the Steering Committee. For details on how to apply please email the study coordinator or PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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