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Trials Tracker

Due to COVID-19 some cystic fibrosis (CF) clinical trials may be suspended with new trials postponed. Please 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. We are constantly updating and developing the functionality of the Trials Tracker – please help us by completing the online poll or contact us at clinicaltrials@cysticfibrosis.org.uk.




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Clinical trials

1-5 of 61 results for all trials

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Trial status

A Phase 2 study of ABBV-3067 alone and in combination with ABBV-2222

In this study, participants will be given ABBV-3067 (“potentiator”) and ABBV-2222 (“corrector”) to see if treatment improves participants’ lung function. Different groups of participants will receive different doses, and some will receive a dummy drug (“placebo”). This study evaluates the safety and efficacy (how well the medications work) of the medications and the best dose of each medicine to be used in future studies. This is a Phase 2, double-blinded (treatment type is unknown to participants and investigators) study in people with CF who have two copies of the F508del mutation (the most common CFTR gene mutation). Participants go through a screening process (up to a month) and receive study treatment for up to a month, followed by a review, a month later. Tests done for the study include lung function tests, sweat chloride tests, blood and urine tests, and ECG. Side effects are monitored through the course of the study.

Read more Phase II
  • Trial Reference Number

    123868

  • Trial status

    Closed

  • Therapeutic category

    Restore CFTR Function

A dose finding study in patients aged 12 and above with cystic fibrosis using the Respimat® inhaler

The BALANCE CF TM1 trial will compare different doses of a new medication ‘BI 1265162’ and determine if this new medication is safe and effective to treat CF. This trial will also investigate how subjects’ bodies absorb and digest BI 1265162 by measuring study participants blood at specific intervals after taking the medication. The new medication BI1265162 is an ENaC inhibitor which means it blocks the epithelial sodium (Na) channel (ENaC) of the airway surface layer. By blocking this channel, your mucus should be less sticky which may improve your lung function. The medication is an inhaled oral medication using the Respimat® device. You will take the inhaler on top of your current CF treatment, whatever CF genes you have. If you are suitable to join the study, you will be randomly assigned to receive one of the different doses of BI1265162 or placebo. The trial will last approximately 7 weeks and involve 6 visits to the hospital. You will be asked to complete questionnaires, have blood samples, an ECG, lung function tests and a Multiple Breath Washout Test.

Read more Phase II
  • Trial Reference Number

    120382

  • Trial status

    Closed

  • Therapeutic category

    Mucociliary Clearance

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

A study of the combined effects of three CFTR modulator medicines in children with cystic fibrosis aged 6 to 11 (VX18-445-106)

VX-445 is an investigational medicine being studied to see how well it works and how safe it is in children with cystic fibrosis aged 6 to 11 years, when taken in combination with tezacaftor and ivacaftor. All three medicines are CFTR modulators which means that they help the faulty CFTR protein found in cystic fibrosis to work properly. Tezacaftor is already approved for use and is what is known as a ‘corrector’. Ivacaftor is also already approved for use and is what is known as a ‘potentiator’. VX-445 is a corrector. Trial participants will be asked to take VX-445, tezacaftor and ivacaftor in the morning (2 tablets), and ivacaftor in the evening (1 tablet). Everyone in the study will receive all three of the study medications, no placebo is involved. This study is divided into two parts. Part A will recruit 12 people who will be asked to come into clinic around 6 times over 10 weeks. Part B will recruit 56 people who will be asked to come into clinic around 11 times over 32 weeks. During visits, the effect of the treatment on your CF will be measured with sample collection, lung function, questionnaires, and other medical checks.

Read more Phase III
  • Trial Reference Number

    126329

  • Trial status

    Closed

  • Therapeutic category

    Restore CFTR Function

How PWCF interpret and respond to the PAM-13

This study focuses on the usage of the PAM-13 which is being used as one of the secondary outcome measures to evaluate the intervention we developed. While we would expect that people with higher patient activation scores or levels would have higher levels of adherence no such pattern could be discerned from an initial analysis of the pilot trial baseline data (WP 3.1, Arden et al., unpublished). This has led to the question of how patients with Cystic Fibrosis in the UK interpret and respond to the PAM-13. Given the limited existing evidence of the effectiveness of the PAM-13 in UK patients, especially those with multiple co-morbidities, it is for the ACtiF programme, as well as the usage of the PAM-13 across the UK in a range of contexts that we understand how people are interpreting and responding to the items of the PAM-13. This study therefore aims to use a 'think-aloud' methodology to investigate how people with CF, and with other co-morbidities, understand and answer the PAM-13.

Read more Not Applicable
  • Trial Reference Number

    94612

  • Age

    18+

  • Length of participation

    1 day

  • Trial status

    Completed

  • Therapeutic category

    Behavioral

1-5 of 61 results for all trials