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Cystic Fibrosis Trust

Trials Tracker

Welcome to the Trials Tracker, bringing together all the cystic fibrosis (CF) trials currently recruiting in the UK so that you can find clinical trials you can take part in both in your region and further afield. The Trials Tracker is a new resource that we’ll be developing over time based on your feedback. If you’ve used the Trials Tracker and want to share your opinion, please complete our online poll or get in touch at clinicaltrials@cysticfibrosis.org.uk.

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Clinical trials

16-20 of 25 results for all trials

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Trial status

Inclusion age

FEV1

Study design

Location

Mutation

Therapeutic category

CF START

CF START is a national UK trial that will determine the safest and most effective antibiotic strategy for infants diagnosed with cystic fibrosis (CF). 480 CF infants will be randomly allocated either flucloxacillin prophylaxis (the current UK standard of care) or antibiotics given in a more targeted manner. The primary outcome will be the age at first growth of Pseudomonas aeruginosa from a respiratory culture (an important safety measure for families). All outcomes will be recorded on a national CF Registry, including a number of secondary outcomes assessing effectiveness and safety. Finally at 40-48 months, a measure of respiratory function will be undertaken in a central laboratory, which will provide a clearer indication of the effectiveness of these two strategies.

Not Applicable
  • Age

    0 - 12

  • Length of participation

    48 months

  • Trial status

    Open to recruitment

  • Therapeutic category

    Anti-Infective

ACtiF - RCT and parallel process evaluation (WP 3.2 and 3.3)

Cystic Fibrosis (CF) affects 10000 people in the UK. The lungs of people with CF (PWCF) are prone to infections and require daily medication to stay healthy. Average adherence to medication has been shown to be only 36%. Poor adherence is associated with poor clinical outcomes including distressing unscheduled hospitalisations. We have designed an intervention that will feedback adherence data to PWCF using chipped nebulisers displaying real time treatment use on smartphones and the website (CFHealthhub). Feedback is a powerful support to habit formation and the interventionist will use CFHealthHub and a behaviour change manual to support PWCF in building successful treatment habits. This work package follows on from a successful Pilot and Feasibility (WP 3.1) study that successfully met the recruitment target to deem the main RCT feasible. This was based on recruiting 64 PWCF over four months at two CF centres (across three NHS Trusts) between June and September 2016. For this main RCT we aim to recruit PWCF for seven months at up to 20 CF units. We intend to recruit 688 PWCF overall. A computer will decide whether people who consent to be in the study will receive usual care alone or also receive the intervention. Both groups have a short period of two to four weeks when data is collected through their nebulisers and fed back to the website. It is only after that period that those allocated to the intervention are allowed to use the website and receive enhanced care from the interventionist. After that point, all participants are followed up for 12 months. Participants will complete a series of questionnaires at the outset and at 12 months.

Not Applicable
  • Length of participation

    12 months

  • Trial status

    Project in Setup

  • Therapeutic category

    Behavioral

CLIMB-CF

Cystic fibrosis affects around 10,000 people in the UK and an estimated > 100,000 worldwide. It is a multisystem condition, with lung disease being the most significant, leading to early infection, inflammation and scarring. Currently, despite huge improvements in clinical care, the median age of death in the UK is just over 30 years. Babies are now diagnosed on newborn screening and are usually asymptomatic, but lung disease begins early. Disease progression is variable and influenced by a number of factors, one of the most important being the frequency of pulmonary exacerbations (PEx), poorly understood periods of increasing symptoms and a fall in lung function; with a quarter of patients experiencing a PEx having permanent loss of lung function as a result. Currently, PEx are detected once fully established; earlier detection, perhaps by monitoring for warning signs in the community, could lead to earlier treatment and improved outcomes. We will aim to recruit all paediatric patients at the Royal Brompton Hospital to look in-depth at their specific characteristics and to look for potential biomarkers in samples collected at home or in clinic to identify a PEx before it's established. A subset will fill in either a web based symptom diary or be given home monitoring equipment and carry out home sample collection over 6 months as part of a multi-centre study. The children will be separated into age bands for analysis (0-2 yrs, 3-5 yrs, 6-11 yrs, 12-17 yrs inclusive) in order to correct for the potentially more risky period of adolescence. The aim of this study is to test the feasibility of home monitoring and sample collection at home or in clinic to identify these PEx without adversely affecting quality of life. We aim to identify the most at risk patients in each age group in order to direct potential interventions.

Pilot/Feasibility
  • Length of participation

    6 Months

  • Trial status

    Open to recruitment

  • Therapeutic category

    Other

Study of CTX 4430 in Cystic Fibrosis Patients

The purpose of this study is to assess the safety and tolerability of multiple oral doses of CTX-4430 when administered to cystic fibrosis (CF) patients once-daily (QD) for 15 days. This study will include two dose levels. For each dose level, blood samples will be collected for exploratory PK and PD assay validation. In addition, sputum will be collected for exploratory biomarker analysis. Following multiple dose administration, pulmonary function and exploratory lung clearance index (LCI) measurements will be taken.

Phase II/III
  • Age

    18+

  • Length of participation

    55 weeks

  • Trial status

    Open

  • Therapeutic category

    Anti-Inflammatory

VX14770116: Ph IV Observational Study for CF Patients

The study is being done to learn more about the effectiveness of Kalydeco in CF patients with the following specific gene mutaions: G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D. The study also looks to explore the effect of Kalydeco on your quality of life. This is an observational study. This means that your cystic fibrosis treatment and medical care will not change because you are participating in this study and the sponsor will not pay for Kalydeco. Your doctor will continue to make all decisions regarding your proper treatment and care. No part of this study is experimental.

Phase IV
  • Mutation

    No copies of F508del

  • Age

    0 - 12

  • Length of participation

    48 months

  • Trial status

    Open

  • Therapeutic category

    Other

16-20 of 25 results for all trials