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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

46-50 of 63 results for all trials

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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

    Closed to recruitment

  • Therapeutic category

    Nutritional-GI

Remote monitoring & gaming technology for children with CF

Airway clearance treatments (ACTs) and physical activity can mitigate the progression of CF lung disease, but these routine physiotherapy treatments are burdensome and adherence is low. Traditional research methods have failed to produce credible evidence to guide practice, partly because ‘blinding’ isn’t possible and patient preference can confound results. We have worked with engineers and designers to develop an electronically chipped sensor (Fizzyo sensor) which mounts onto standard widely used airway clearance devices. This sensor monitors breathing during routine airway clearance. Additionally wearable activity trackers can monitor physical activity. We can now facilitate automatic transmission of ACT and physical activity data to clinicians and researchers caring for children with CF. Industry partners (Microsoft) and UCL computer science experts have helped us build an airway clearance and physical activity feedback dashboard app for patients and carers. This team has also developed computer games driven by breathing through an airway clearance device for this app (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 and physical activity to assess impact of different adherence levels on clinical outcomes. Innovative big data analysis methods will be used to find out whether: 1) Children with CF should do regular ACTs or physical activity, and what the minimum effective dose is 2) Physical activity levels have an impact on clinical outcomes 3) Airway clearance or physical activity is more effective in different children (and how to choose) 4) Some ACTs are better than others 5) Airway clearance gaming helps children do treatments more regularly, and whether better adherence improves health 6) Remote monitoring and big data analysis can provide a valuable alternative to traditional research methods and help identify sensitive composite outcome measures for children with mild signs and symptoms.

Read more Not Applicable
  • Trial Reference Number

    110390

  • Length of participation

    14 months

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Behavioral

VX17-659-105 Open-label Safety and Efficacy of VX-659 in CF

This study will evaluate the long-term safety and tolerability of VX-659 in triple combination with Tezacaftor and Ivacaftor in subjects with cystic fibrosis (CF), including but not limited to those who are heterozygous for the F508del mutation

Phase III
  • Trial Reference Number

    108792

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Restore CFTR Function

The Effect of an Anti-Fungal medicine (PC945) on Aspergillus Fumigatus Lung Infection in Patients with Cystic Fibrosis Details

This study tests the effects of an experimental drug PC945 in people with cystic fibrosis whose lungs are infected by the fungus Aspergillus fumigatus. PC945 may be useful in treating patients infected with Aspergillus fumigatus as, unlike the usual treatments, it is inhaled into the lung and has been designed to stay there and treat the infection. Participants will continue to be treated with their usual cystic fibrosis treatment and will also receive PC945. The amount of fungus in the patients' phlegm will be measured over the course of the study. The study will take place at multiple sites in UK and will include approximately 18 participants. The maximum study duration will be about 16 weeks.

Read more Phase II
  • Trial Reference Number

    108550

  • Age

    18+

  • Trial status

    Completed

  • Therapeutic category

    Anti-Infective

Infant Multi-Breath washout Study

Lung Clearance Index (LCI) measured by multiple breath washout (MBW) has been shown to be a sensitive and non-invasive method of detecting early airways disease in infants with cystic fibrosis (CF). An abnormal measurement at a young age has been shown to track into later life, and could identify children that require more aggressive treatment earlier on. Currently however there is a lack of multi-centre data and of suitable scalable methodologies that can be used outside of highly specialised settings. This is a multi-centre longitudinal observational study of this measurement, LCI, in children younger than 3 years with CF, with a healthy control group and a disease group of babies who were born early. A novel method for MBW will be used, which has been developed and previously assessed in a pilot study at RMCH. We aim to show that LCI can be reliably measured across multiple centres using this method, with high rates of success and repeatability in the short term (2-3 months). We will also track any change in the children with CF and ex-premature babies in the longer term (12-18months). All parents will be consented prior to taking part in the study. The first LCI measurements on children with CF will be undertaken as soon as possible after diagnosis or recruitment, then 2-4 months and 12-18 months later. Infants who were born early (currently well, with no supplemental oxygen requirement) will have LCI close to, and ideally before NICU discharge and then 12 months later. Healthy controls under 3 years of age with no other comorbidity or respiratory concerns will be seen once whilst being sedated for other investigations. The children will be sedated as per local protocol, but at lower doses than previously used and than routinely used for scans in order to allow quicker discharge.

Read more Not Applicable
  • Trial Reference Number

    107844

  • Trial status

    Open to recruitment

  • Therapeutic category

    Other

46-50 of 63 results for all trials