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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

26-30 of 39 results for all trials

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Inclusion age

FEV1

Trial type

Location

Mutation

Therapeutic category

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

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

    Closed to recruitment - no follow up

  • Therapeutic category

    Anti-Inflammatory

CF START

CF START is a national UK trial that will determine the safest and most effective antibiotic strategy for infants diagnosed with cystic fibrosis (CF). 480 CF infants will be randomly allocated either flucloxacillin prophylaxis (the current UK standard of care) or antibiotics given in a more targeted manner. The primary outcome will be the age at first growth of Pseudomonas aeruginosa from a respiratory culture (an important safety measure for families). All outcomes will be recorded on a national CF Registry, including a number of secondary outcomes assessing effectiveness and safety. Finally at 40-48 months, a measure of respiratory function will be undertaken in a central laboratory, which will provide a clearer indication of the effectiveness of these two strategies.

Not Applicable
  • Age

    0 - 12

  • Length of participation

    48 months

  • 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

    Archived

  • Therapeutic category

    Restore CFTR Function

CLIMB-CF

Cystic fibrosis affects around 10,000 people in the UK and an estimated > 100,000 worldwide. It is a multisystem condition, with lung disease being the most significant, leading to early infection, inflammation and scarring. Currently, despite huge improvements in clinical care, the median age of death in the UK is just over 30 years. Babies are now diagnosed on newborn screening and are usually asymptomatic, but lung disease begins early. Disease progression is variable and influenced by a number of factors, one of the most important being the frequency of pulmonary exacerbations (PEx), poorly understood periods of increasing symptoms and a fall in lung function; with a quarter of patients experiencing a PEx having permanent loss of lung function as a result. 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.

Pilot/Feasibility
  • Length of participation

    6 Months

  • Trial status

    Open to recruitment

  • Therapeutic category

    Other

26-30 of 39 results for all trials