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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 49 results for all trials

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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.

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  • Trial Reference Number

    97027

  • Length of participation

    14 months

  • Trial status

    Closed

  • 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

HIT - CF Organoid Study

Cystic fibrosis is caused by gene changes (‘mutations’) in the CF gene ,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 study is the 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.

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  • Trial Reference Number

    119685

  • Trial status

    Project in Setup

  • Therapeutic category

    Restore CFTR Function

Intravenous iron in adults with cystic fibrosis

Cystic fibrosis (CF) is an inherited condition affecting over 10,000 patients in the UK, which leads to recurrent chest infections and poor absorption of nutrients from the gut. In the past, patients with CF died in childhood, but most now survive into adulthood. However, they require frequent contact with healthcare services, expensive and time-consuming treatments, and have poor health-related quality of life. Adults with cystic fibrosis often have low iron levels (iron deficiency). This is partly due to poor absorption of iron from the gut, and partly to the trapping of iron within cells of the immune system during periods of infection. Unfortunately, iron tablets are often ineffective in this setting, and may cause significant side effects in patients with cystic fibrosis. In other patient groups, intravenous iron is used routinely to correct iron deficiency. In these patients it has been shown to be safe, and to improve energy levels, exercise tolerance, cognitive function and quality of life, even in the absence of anaemia. Recent research suggests that iron may be particularly beneficial in patients with heart and lung disease. Despite these possible benefits, IV iron is rarely used in patients with CF, due in part to concerns about encouraging the growth of bacterial in the lungs. Iron deficiency therefore often goes untreated. However, since no clinical trials have examined the use of IV iron in CF patients to date, the risks and benefits remain uncertain. We plan to undertake a small pilot study examining the effects of IV iron in 20 adults with CF and low iron levels. We will primarily assess whether intravenous iron is safe and effective at treating iron deficiency in this group, but will also study various other clinical parameters, to guide the design of future larger studies.

Read more Phase IV
  • Trial Reference Number

    110427

  • Age

    18+

  • Trial status

    Open to recruitment

  • Therapeutic category

    Nutritional-GI

A Phase 1/2 Study of VX-121 in Subjects With Cystic Fibrosis and in Subjects without Cystic Fibrosis (VX17-121-001)

The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis.

Phase I/II
  • Trial Reference Number

    111537

  • Mutation

    One copy of F508del

  • Age

    18+

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Restore CFTR Function

6-10 of 49 results for all trials