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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

26-30 of 40 results for all trials

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CFHealthHub Data Observatory

Cystic Fibrosis (CF) affects 10000 people in the UK. The lungs of people with CF (PWCF) are prone to infections and require daily medication to stay healthy. Average adherence to medication has shown to be only 36%. Poor adherence is associated with poor clinical outcomes including distressing unscheduled hospitalisations. Previous research has been undertaken to design a website (CFHealthhub) which records personal adherence data using chipped nebulisers and understand whether this can build successful treatment habits. In the current project we will develop CFHealthHub as a data observatory which will record adherence data and other indicators of health and patient care held in patient notes. The purpose of this is two- fold; to support local and national Quality Improvement (QI) projects aiming to improve an individual’s adherence to treatment and the quality of care delivered by the CF centre. Secondly, collecting adherence data from a large number of PWCF may support future research studies whereby CFHealthHub is used as a source of participants and data. We aim to recruit PWCF who use chipped nebulisers from 4 CF centres across in England. PWCF will be consented to 1) share their identifiable data with their local CF team 2) share data, from which they cannot be identified, with all CF centres in the study 3) share data, from which they cannot be identified, in future research studies which result in no changes to their care and 4) share data to be included for selection to future studies which may result in changes to care, such as testing new treatments. Consent in any combination can be provided and withdrawn at any time. Participants who consent to 'selection' for future studies will also be provided with information specific to the new study and the opportunity to decline participation, if selected from the data observatory.

Read more Not Applicable
  • Trial Reference Number

    95070

  • Length of participation

    Up to 6 years

  • Trial status

    Open to recruitment

  • Therapeutic category

    Behavioral

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.

Read more Phase II
  • Trial Reference Number

    89452

  • 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.

Read more Not Applicable
  • Trial Reference Number

    86464

  • 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.

Read more Phase I
  • Trial Reference Number

    88595

  • Mutation

    One copy of F508del

  • Age

    18+

  • Length of participation

    6 months

  • Trial status

    Archived

  • Therapeutic category

    Restore CFTR Function

ACtiF - RCT and parallel process evaluation (WP 3.2 and 3.3)

Cystic Fibrosis (CF) affects 10000 people in the UK. The lungs of people with CF (PWCF) are prone to infections and require daily medication to stay healthy. Average adherence to medication has been shown to be only 36%. Poor adherence is associated with poor clinical outcomes including distressing unscheduled hospitalisations. We have designed an intervention that will feedback adherence data to PWCF using chipped nebulisers displaying real time treatment use on smartphones and the website (CFHealthhub). Feedback is a powerful support to habit formation and the interventionist will use CFHealthHub and a behaviour change manual to support PWCF in building successful treatment habits. This work package follows on from a successful Pilot and Feasibility (WP 3.1) study that successfully met the recruitment target to deem the main RCT feasible. This was based on recruiting 64 PWCF over four months at two CF centres (across three NHS Trusts) between June and September 2016. For this main RCT we aim to recruit PWCF for seven months at up to 20 CF units. We intend to recruit 688 PWCF overall. A computer will decide whether people who consent to be in the study will receive usual care alone or also receive the intervention. Both groups have a short period of two to four weeks when data is collected through their nebulisers and fed back to the website. It is only after that period that those allocated to the intervention are allowed to use the website and receive enhanced care from the interventionist. After that point, all participants are followed up for 12 months. Participants will complete a series of questionnaires at the outset and at 12 months.

Read more Not Applicable
  • Trial Reference Number

    89701

  • Length of participation

    12 months

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Behavioral

26-30 of 40 results for all trials