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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

1-5 of 52 results for all trials

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A dose finding study of OligoG in patients with CF

The study will be a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose finding study in patients with cystic fibrosis. The trial is divided into two parts, with part 1 designed to identify the best dose, while part 2 is designed to assess the efficacy, safety and tolerability of the inhaled alginate oligosaccharide OligoG compared to placebo after 26 weeks of treatment, followed by a 26 weeks open label extension. Randomised patients will receive daily administrations of OligoG or placebo, both administered in addition to standard of care for 26 weeks. All patients will be offered OligoG in an open label study extension of an additional 26 weeks.

Read more Phase II
  • Trial Reference Number

    106614

  • Trial status

    Project in Setup

  • Therapeutic category

    Anti-Infective

HIT-CF Organoid Study

Over 2000 mutations in CFTR have been identified. New innovative and effective ‘mutation-specific’ drugs are available or in development for up to 90% of people with CF (ie. those with the most common 20-30 mutations). These are called ‘CFTR modulators.’ However, this leaves an important minority (~10%) of people with CF with no modulator in development as their mutations are very rare and only a small number of individuals have these specific mutations, making studying these patients in traditional trials very challenging. Therefore, the Human Individualized Treatment for CF (HIT-CF) project has been developed to address this unmet need, ie. to develop personalised treatments for this important group. HIT-CF is a Europe-wide, multi-centre project, which comprises two parts: This IRAS submission relates to the first part - the organoid study - in which patients with rare CFTR mutations will be recruited and intestinal organoids produced from rectal biopsies from each patient will be generated. Intestinal organoids, sometimes called ‘mini-intestines,’ are cell cultures made from stem cells so they contain the same mutations as the person from whom the biopsies are derived. Using this laboratory model, candidate modulator drugs can then be tested to assess for responsiveness (thus potentially predicting response in real life). In the second part of HIT-CF - the clinical trial - these modulators will then be tested in patients identified from the organoid study as likely responders, thus increasing the likelihood of showing efficacy. We plan to test drugs on organoids derived from 500 patients across Europe.

Read more Not Applicable
  • Trial Reference Number

    119685

  • Trial status

    Project in Setup

  • Therapeutic category

    Restore CFTR Function

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

    Open to recruitment

  • 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

  • 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

1-5 of 52 results for all trials