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300 CF patients join study to unlock secrets of dangerous lung Flare-Ups

NCT ID NCT06940531

Knowledge-focused Sponsor: Alexander Horsley Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 300 people with cystic fibrosis for one year to learn what triggers sudden worsening of symptoms, called exacerbations. Participants provide regular health data and samples, and some will also have extra clinic visits and home monitoring. The goal is to find early warning signs so future treatments can prevent these episodes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

United Kingdom

Ages

5 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis (CF) Cystic fibrosis pulmonary exacerbation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Birmingham Heartlands Hospital

    NOT_YET_RECRUITING

    Birmingham, B9 5SS, United Kingdom

  • Blackpool Teaching Hospitals

    NOT_YET_RECRUITING

    Blackpool, FY3 8NR, United Kingdom

  • Cardiff and Vale University Health Board

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Chest Unit Reception, King's College Hospital

    NOT_YET_RECRUITING

    London, SE5 9RS, United Kingdom

  • John Radcliffe Hospital

    NOT_YET_RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Leeds Adult CF Centre

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Liverpool Heart & Chest Hospital

    RECRUITING

    Liverpool, L14 3PE, United Kingdom

  • Manchester Adult Cystic Fibrosis Centre

    RECRUITING

    Manchester, Manchester, M23 9LT, United Kingdom

  • Medical Research Unit, Bristol Royal Infirmary

    NOT_YET_RECRUITING

    Bristol, BS2 8HW, United Kingdom

  • NHS Greater Glasgow and Clyde

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • National Institute for Health Research Clinical Research Facility

    NOT_YET_RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • Newcastle Adult CF Centre

    NOT_YET_RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Nottingham City Hospital

    NOT_YET_RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Royal Brompton Hospital, Department of Cystic Fibrosis (Adult)

    NOT_YET_RECRUITING

    London, SW3 6LL, United Kingdom

  • Royal Devon and Exeter Hospital (Wonford)

    RECRUITING

    Exeter, EX2 5DW, United Kingdom

  • Royal Stoke University Hospital

    NOT_YET_RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • York Hull Adult Cystic Fibrosis Centre

    RECRUITING

    York, YO31 8HE, United Kingdom

  • York Hull Adult Cystic Fibrosis Centre

    RECRUITING

    York, YO31 8HE, United Kingdom

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