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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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Study Designed to Assess the Safety, Tolerability and PK of PTI-808 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

Parameters to assess Response to Intra-Venous Antibiotic Treatment for pulmonary Exacerbations in Cystic Fibrosis

Acute changes in respiratory signs and symptoms termed Pulmonary Exacerbations require treatment with intravenous antibiotics and hospital admission. These episodes cause substantial disruption to people's lives and impact on lung function, quality of life and lifespan. Current treatment regimes require improvement but further study is needed to identify who might benefit from a different approach. This observational study aims to assess if multi-dimensional measurements taken during treatment correspond with later treatment response. This may allow us to personalise treatment more effectively in the future and to better understand how individuals respond to treatment. As yet there is no model for predicting how patients with CF will respond to IV antibiotic treatment- other than clinical judgement and lung function response.This is due to lack of robust measures to identify clinical response at the time of treatment and safely predict later clinical outcomes. The heterogeneity of the 21st Century CF population means a multi-dimensional composite measure is needed. This study has therefore been designed to provide an overall picture of people's response including clinical, biochemical and patient related outcome measures. Using multi-dimensional assessment we hope the measures assessed in this study will give a better picture of how people feel and how they respond to treatment.

Read more Not Applicable
  • Trial Reference Number

    84648

  • Age

    18+

  • Trial status

    Closed to recruitment

  • Therapeutic category

    Other

Intravenous iron in adults with cystic fibrosis

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 dose finding study of OligoG in patients with Cystic Fibrosis

OligoG is a small sugar molecule that comes from seaweed, harvested off the coast of Norway. Studies indicate that OligoG may make CF mucus less sticky, and it may also help antibiotics to combat infections. Although OligoG has been tested and found to be safe in about 130 CF patients, more research is needed to find the best dose and to study the effect of longer term use. OligoG is given as a dry powder for inhalation. Ten capsules are to be taken twice daily. During this study patients may take their other usual medications in addition to OligoG. Part 1 will be a three month long study to find the best of three different doses. Each patient will be given one of three different OligoG doses, or a placebo (placebo is a product that looks like the test medication, but it does not contain any OligoG). This means that 3 of 4 patients will receive active medication You will be asked to visit the clinic 7 times in Part 1.Part 2 is designed to assess the efficacy, safety and tolerability of the chosen dose of OligoG compared to placebo following 26 weeks of treatment. The patients will take OligoG or placebo twice daily for 26 weeks. Half of the patients will receive active drug. You will be asked to visit the clinic 10 times in Part 2.

Read more Phase II
  • Trial Reference Number

    106614

  • Trial status

    Project in Setup

  • Therapeutic category

    Anti-Infective

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

    Project in Setup

  • Therapeutic category

    Restore CFTR Function

1-5 of 54 results for all trials