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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 54 results for all trials

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Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor

This study will look at whether two drugs (called lumacaftor and ivacaftor) can help treat cystic fibrosis when taken together over a long period of time. It will also look at whether they are safe over this period. You can only take part in this study if you took part in a study called VX14-809-109, and if you meet certain criteria. These criteria will be checked by the study doctor and nurse at a screening visit. If you meet these criteria you will be treated with lumacaftor and ivacaftor together for approximately 96 weeks. A follow up visit will be held 28 days after the last dose of lumacaftor and ivacaftor. You will need to attend the clinic for 15 visits over the study duration and will undergo a range of tests. Participants who stopped taking the study drugs early in the VX14-809-109 study will be invited to take part in an observational study. They will not receive the study drug but will receive regular phone calls.

Read more Phase III
  • Trial Reference Number

    50600

  • Age

    0 - 12

  • Length of participation

    96 weeks

  • Trial status

    Closed

  • Therapeutic category

    Restore CFTR Function

PlayPhysio Mobile App Study for young people with Cystic Fibrosis

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

    Closed to recruitment

  • Therapeutic category

    Other

HIT-CF Organoid Study

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

    Open to recruitment

  • Therapeutic category

    Restore CFTR Function

Study Designed to Assess a CFTR modulator in Adults with Cystic Fibrosis

In this study, the investigational CFTR modulator medicine PTI-808 will be given in combination with one or two other investigational modulator medicines, PTI-801 and PTI-428. PTI-428, PTI-801, and PTI-808 are considered cystic fibrosis transmembrane conductance regulator (CFTR) modulators being developed to treat the underlying cause of cystic fibrosis. PTI-428 is a CFTR amplifier that increases the amount of CFTR protein in the cell, PTI-801 is a CFTR corrector that improves the processing of CFTR protein in the cell, and PTI-808 is a CFTR potentiator to enhance the activity of CFTR at the cell surface. Modulators on their own have been shown to have limited activity, and it is predicted that combining modulators will be necessary to address CFTR defects. There is a screening visit up to 4 weeks before the active portion of the study, which lasts 4 weeks. In the active portion of the study, participants will take one of the following: PTI-808 by mouth in combination with PTI-801 and PTI-428, PTI-808 in combination with PTI-801 and placebo, or all placebos for 4 weeks. The study medication is taken once a day at breakfast. Two weeks after stopping the study medication, another visit will occur.

Read more Phase II
  • Trial Reference Number

    124674

  • Age

    18+

  • Trial status

    Open to recruitment

  • Therapeutic category

    Restore CFTR Function

A Study to Assess various doses of an ENaC inhibitor medication (mucociliary clearance) in Healthy Volunteers and People with Cystic Fibrosis

This study will be conducted in 3 parts: a single ascending dose leading to a multiple ascending dose (MAD) in healthy volunteers, followed by a MAD in participants with cystic fibrosis. The study will enroll approximately 88 subjects. The study will consist of 4 single-dose randomized cohorts. Subjects enrolled will receive a single inhaled dose of the Study Drug (IONIS-ENaCRx or placebo) on Day 1.

Read more Phase I/II
  • Trial Reference Number

    122847

  • Age

    18+

  • Trial status

    Open to recruitment

  • Therapeutic category

    Mucociliary Clearance

1-5 of 54 results for all trials