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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

6-10 of 54 results for all trials

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Therapeutic category

High-flow nasal therapy during exercise in CF

High flow nasal therapy (HFNT) is a way to deliver a mixture of air and oxygen at higher flows compared to standard oxygen therapy. It has been shown to improve oxygenation, reduce breathlessness and breathing rate, and is quite comfortable. Recently HFNT has been shown to improve exercise capacity and tolerance in patients with other lung diseases. HFNT is routinely used in clinical practice in patients with CF who present acutely unwell during hospital admissions. We believe that HFNT could be used by patients with CF during exercise in order to improve their tolerance, lengthen their exercise sessions, and allow them to be less symptomatic. We propose an initial, small-scale pilot study to assess the feasibility of a larger trial to assess efficacy. The study aims to enrol 20 patients with severe lung disease, during a hospital admission. On top of their routine 6-minute walking test, patients will be asked to have a repeated test on HFNT and to fill in a questionnaire on their physical activity. As exploratory outcomes, we will measure distance walked during the tests, oxygen and carbon dioxide levels, breathing rate, and time to recover to baseline. Patients will be asked to rate their comfort and their breathlessness.

Read more Not Applicable
  • Trial Reference Number

    121917

  • Age

    18+

  • Trial status

    Open to recruitment

  • Therapeutic category

    Other

HOPE-1

Evaluation of potential mucus clearing treatment for all patients with CF regardless of mutation

Phase II
  • Trial Reference Number

    99066

  • Age

    18+

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Mucociliary Clearance

Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis. A randomised controlled trial and parallel process evaluation.

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.

Read more Not Applicable
  • Trial Reference Number

    89701

  • Length of participation

    12 months

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Behavioral

Remote monitoring & gaming technology for children with CF

Airway clearance treatments (ACTs) and physical activity can mitigate the progression of CF lung disease, but these routine physiotherapy treatments are burdensome and adherence is low. Traditional research methods have failed to produce credible evidence to guide practice, partly because ‘blinding’ isn’t possible and patient preference can confound results. We have worked with engineers and designers to develop an electronically chipped sensor (Fizzyo sensor) which mounts onto standard widely used airway clearance devices. This sensor monitors breathing during routine airway clearance. Additionally wearable activity trackers can monitor physical activity. We can now facilitate automatic transmission of ACT and physical activity data to clinicians and researchers caring for children with CF. Industry partners (Microsoft) and UCL computer science experts have helped us build an airway clearance and physical activity feedback dashboard app for patients and carers. This team has also developed computer games driven by breathing through an airway clearance device for this app (to enhance treatment enjoyment and adherence). The project will use this technology for passive remote capture and transmission of daily longitudinal data during airway clearance and physical activity to assess impact of different adherence levels on clinical outcomes. Innovative big data analysis methods will be used to find out whether: 1) Children with CF should do regular ACTs or physical activity, and what the minimum effective dose is 2) Physical activity levels have an impact on clinical outcomes 3) Airway clearance or physical activity is more effective in different children (and how to choose) 4) Some ACTs are better than others 5) Airway clearance gaming helps children do treatments more regularly, and whether better adherence improves health 6) Remote monitoring and big data analysis can provide a valuable alternative to traditional research methods and help identify sensitive composite outcome measures for children with mild signs and symptoms.

Read more Not Applicable
  • Trial Reference Number

    110390

  • Length of participation

    14 months

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Behavioral

Playphysio

There are many oscillatory PEP devices on the market to use for chest physiotherapy, with strong evidence that they are effective treatments in clearing the lungs. However, they don’t provide the user feedback to confirm that they are using the correct technique or indicate when each blow or treatment session has been completed. As a result this can lead parents to have a lack of confidence in whether their child is completing the physiotherapy session correctly or completely.A father of a CF patient has developed a device alongside the CF team at Cambridge University Hospital called Play Physio, that can be attached to any oscillatory PEP device. The patient can play games which have been designed to encourage the child to comply with the routine and data is collected and sent to the treating clinician in order to monitor compliance. The aims of this study are to look into the safety and efficacy of the Play Physio device and to investigate the effect of the device on compliance. This is a 24 week study in which the CF patients (ages 8-16) use the Play Physio ® device and associated app. Lung function, paper diaries, in app questionnaires and compliance data will all be analysed.

Read more Not Applicable
  • Trial Reference Number

    110395

  • Trial status

    Open to recruitment

  • Therapeutic category

    Other

6-10 of 54 results for all trials