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Cystic Fibrosis Trust

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

11-15 of 25 results for all trials

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Trial status

Inclusion age

FEV1

Study design

Location

Mutation

Therapeutic category

AZTEC-CF - Gilead IN-UK-205-4065

This study’s primary objective is to investigate whether there is immediate clinical benefit in the use of Cayston® in acute exacerbations of CF. Repeated courses of antibiotics via a drip (also known as intravenous or IV antibiotics) can cause long-term side effects including deafness and chronic kidney disease. It is therefore important to explore newer approaches for treating chest infections in CF. Nebulised antibiotics provide an opportunity to deliver antibiotics straight to the lungs with significantly less of the drug being absorbed into the blood stream. This means that potential side effects and long-term damage to other organs are minimised. Furthermore nebulised antibiotics are generally well tolerated, less invasive and require less time to administer. AZTEC-CF aims to evaluate whether inhaled antibiotic treatment is beneficial in the treatment of acute chest infections

Phase IV
  • Age

    18+

  • Length of participation

    2 exacerbations

  • Trial status

    Open to recruitment

  • Therapeutic category

    Anti-Infective

VERTPh1D

Cystic fibrosis (CF) is an autosomal recessive chronic disease with serious morbidities and frequent premature mortality. At present, there is no cure. CF affects approximately 70,000 individuals worldwide The aims of the study is to evaluate the safety and tolerability of VX-659 in triple combination with TEZ/IVA for 14 days in subjects with CF This is a randomized, double-blind, placebo-controlled, single- and multiple-dose, first-in-human dose escalation study of VX-659 that includes evaluations of relative and absolute bioavailability. Part D (Subjects with CF) Part D has a randomized, double-blind, placebo-controlled, parallel-group design. Approximately 12 subjects will be enrolled and randomized 3:1 to TC:placebo. Subjects will receive 14 days of treatment. Part D may be initiated while Parts A, B, and C are ongoing after review of safety, tolerability, and available PK data. The dose of VX-659 will be at least 1 dose level below the highest Part C dose for which safety and tolerability results are available and supportive. The dosage of TEZ/IVA will be TEZ 100 mg qd/IVA 150 mg q12h, which will be administered as TEZ 100-mg/IVA 150-mg FDC in the morning and IVA 150 mg in the evening. The decision to initiate successive cohorts and dose selection will be based on safety and tolerability data from preceding dose group(s) and available PK data from a minimum of 6 subjects (to ensure 4 subjects receiving active drug) in the preceding cohort.

Phase I
  • Mutation

    One copy of F508del

  • Age

    18+

  • Length of participation

    6 months

  • Trial status

    Closed - follow up complete

  • Therapeutic category

    Restore CFTR Function

Investigating The Effect Of IMT In Children And Adults With CF

The Cystic Fibrosis working group recent recommendations commended the use of physical exercise as part of a multidisciplinary therapeutic strategy, as it has been proven to lower mortality risks in patients. One nonpharmacological intervention which has shown some promising results in recent years is inspiratory muscle training (IMT), which may improve patients’ respiratory muscle and exercise function. Inspiratory muscle training, which involves breathing through a device that provides resistance when you breathe, aims to improve the strength of the lung muscles by making them work harder and therefore making them stronger. Starting IMT in children at the early years of their disease is essential in gaining early health benefits. With adults, Lands et al (1992) found that in later stages of Cystic Fibrosis it is difficult to maintain inspiratory muscle strength, therefore adults adopting IMT training at this stage could increase their muscle strength. In the past 30 years’ life expectancy in Cystic Fibrosis has increased significantly, however as age progresses lung function declines. Therefore, it is essential to determine IMT’s effectiveness in progression from childhood to adulthood. For this new generation of ageing patients, improving lung function and enhancing quality of life is a new challenge for a CF clinical care team, therefore, this potential non-pharmacological intervention warrants further investigation.

Not Applicable
  • Length of participation

    8 - 16 weeks

  • Trial status

    Open

  • Therapeutic category

    Other

Albatross

This is a Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis (CF) with one F508del CFTR mutation and a second gating (class III) mutation. Up to 35 participants are planned to be included in the study for a minimum of 6 weeks and a maximum of 10 weeks. All participants will be at least 18 years of age and have cystic fibrosis with at least one copy of the F508del (Class II) mutation. This study will investigate whether treatment with the corrector GLPG2222 in patients heterozygous for F508del and a gating mutation who are already receiving ivacaftor treatment (standard of care), will result in an additional improvement in CFTR function, as measured by sweat chloride and lung function.

Phase II
  • Age

    18+

  • Trial status

    Open

  • Therapeutic category

    Restore CFTR Function

RPL554-010-2015 - Verona

The study drug, called RPL554, is a potential new inhaled drug that is being developed for the treatment of breathing and lung diseases, including cystic fibrosis. The study drug is a liquid that is breathed in using a device called a nebuliser, which is a commonly used device that turns a liquid into a fine mist that can then be inhaled into the lungs where it can then be taken into the body. Over 240 people have been given RPL554 in clinical studies so far. Two different formulations (how the drug is made up) have been tested in these studies; 105 people have received the original formulation of RPL554 and 144 have received either one dose or up to 11 doses (between 0.4 mg and 24 mg) of a newer formulation of RPL554. If you decide to take part in this study, you will be given two different doses (1.5 mg and 6 mg) of this newer formulation RPL554. You will also be given a placebo (a dummy drug containing the same inactive ingredients as RPL554 but no active ingredients). The main purpose of this study is to look at the effect your body has on the study drug by measuring the amount of RPL554 in your blood (this is called “pharmacokinetics”). The study will also investigate how much RPL554 can open up the airways (bronchodilation), what effect it has on inflammation and what side effects it has.

Phase II
  • Age

    18+

  • Length of participation

    52 days

  • Trial status

    Open

  • Therapeutic category

    Anti-Inflammatory

11-15 of 25 results for all trials