Identifying the Causes and Risk Factors of Pulmonary Exacerbations in Cystic Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorAlexander Horsley
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
300 Participants
are grouped into 4 trial groupsSponsors and collaborators
Alexander Horsley
Lead sponsor
University of Manchester
Sponsor institution
Source ClinicalTrials.gov