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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

16-20 of 56 results for all trials

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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

A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations

This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.

Phase II
  • Trial Reference Number

    101870

  • Age

    18+

  • Length of participation

    3 weeks

  • Trial status

    Completed

  • Therapeutic category

    Mucociliary Clearance

ALPINE 2: AZLI for children with CF and PA lung infection

The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new onset Pseudomonas aeruginosa respiratory tract infection.

Phase III
  • Trial Reference Number

    88959

  • Length of participation

    28 days

  • Trial status

    Open to recruitment

  • Therapeutic category

    Anti-Infective

Remote monitoring & gaming technology for improving outcomes in children with cystic fibrosis

Remote monitoring and gaming technology for improving physiotherapy prescription, adherence and prediction of clinical outcomes in children with cystic fibrosis. Airway clearance, physical activity and exercise can mitigate the progression of CF lung disease, but routine physiotherapy treatments are burdensome and adherence is low. Traditional research has failed to produce credible evidence to guide practice, partly because ‘blinding’ isn’t possible and patient preference can confound results. Following our involvement with the ‘Big Life Fix’ television series https://youtu.be/d6A8R146JWU (BBC2,2016) we have worked with engineers and designers to develop electronically chipped airway clearance devices and wearable activity trackers to facilitate automatic data transmission to clinicians and researchers caring for children with CF. Industry partners (Microsoft) and UCL computer science experts are helping us develop computer games driven by breathing through an airway clearance device (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, physical activity and exercise to assess impact on clinical outcomes. Innovative big data analysis methods will be used to find out whether: Children with CF should do regular ACTs or exercise, and what the minimum effective dose is physical activity levels have an impact on clinical outcomes airway clearance or exercise is more effective in different children (and how to choose) some airway clearance techniques are better than others airway clearance gaming helps children do treatments more regularly, and whether better adherence improves health alternative to traditional research methods and help identify sensitive composite outcome measures for children with mild signs and symptoms.

Read more
  • Trial Reference Number

    97027

  • Length of participation

    14 months

  • Trial status

    Closed

  • Therapeutic category

    Behavioral

16-20 of 56 results for all trials