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Trials Tracker

Due to COVID-19 some cystic fibrosis (CF) clinical trials may be still be temporarily paused, however some trials will begin to re-open soon. If you have any questions about taking part in clinical trials, please speak to our CF team or contact the Trust’s clinical trial team. Please also see the relevant advice on the COVID-19 Q&A page. The Trials Tracker brings together all CF trials currently recruiting in the UK, so you can find clinical trials you can take part in both in your region and further afield




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Clinical trials

26-30 of 64 results for all trials

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Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis.

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 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

  • Therapeutic category

    Behavioral

CLIMB-CF

Currently, PEx are detected once fully established; earlier detection, perhaps by monitoring for warning signs in the community, could lead to earlier treatment and improved outcomes. We will aim to recruit all paediatric patients at the Royal Brompton Hospital to look in-depth at their specific characteristics and to look for potential biomarkers in samples collected at home or in clinic to identify a PEx before it's established. A subset will fill in either a web based symptom diary or be given home monitoring equipment and carry out home sample collection over 6 months as part of a multi-centre study. The children will be separated into age bands for analysis (0-2 yrs, 3-5 yrs, 6-11 yrs, 12-17 yrs inclusive) in order to correct for the potentially more risky period of adolescence. The aim of this study is to test the feasibility of home monitoring and sample collection at home or in clinic to identify these PEx without adversely affecting quality of life. We aim to identify the most at risk patients in each age group in order to direct potential interventions.

Read more Pilot/Feasibility
  • Trial Reference Number

    85717

  • Length of participation

    6 Months

  • Trial status

    Closed to recruitment - in follow up

  • 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: 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

    Closed to recruitment

  • Therapeutic category

    Restore CFTR Function

Lenabasum in Cystic Fibrosis

This study is designed to evaluate the effectiveness and safety of lenabasum (JBT-101) in people with CF who have had pulmonary exacerbations. Lenabasum (JBT-101) is an oral medication that is aimed at reducing inflammation. It is thought to help the body increase production of anti-inflammatory molecules while reducing production of molecules that increase inflammation. Reduction of inflammation helps prevent permanent tissue damage in the lungs that happens when CF patients have pulmonary exacerbations. For study participants this study includes 6 months of study treatment with a 1 month follow up period. Study participants may remain on their current CF treatments

Read more Phase II
  • Trial Reference Number

    106210

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Anti-Inflammatory

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

26-30 of 64 results for all trials