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Research Trials at Exeter


Please select the dropdowns below to find details of upcoming, ongoing, and completed research trials in Exeter.

Study Title: CF Start

Status: Open and recruiting until January 2023

What is the study investigating? To compare two treatment strategies, “Prevent and Treat” flucloxacillin prophylaxis in babies with CF (standard care in the UK) vs “Detect and Treat” antibiotics prescribed depending on swab results.

Who can take part? Babies with CF less than 90 days old

What does it involve? A computer system will be used to choose whether the baby begins on prophylactic flucloxacillin treatment, or receives targeted antibiotics depending on the results of their cough swabs. There won’t be any extra hospital visits but the child’s progress will be followed closely until their 4th birthday

More info can be found at http://www.cfstart.org.uk/

Co-Investigators: Dr Beth Enderby and Dr Patrick Oades

Contact: Sophie Whiteley s.whiteley1@nhs.net

These are studies that have finished recruiting new patients, but are still being worked on in Exeter to collect the results for the study, or recently completed studies. If you have any questions about these studies please direct them to Sophie at s.whiteley1@nhs.net

Study title: Daystar

Status: Closed to recruitment, follow up ongoing

What is the study investigating? The performance of wearable technology in CF subjects taking commercial ELX/TEZ/IVA (Kaftrio) as part of a decentralised trial design.

Results: Study ongoing

 

Study Title: VX18-445-110

Status: Closed to recruitment, follow up ongoing

What is the study investigating? The long term safety and effectiveness of Kaftrio in people with CF aged 12years+ over 96 weeks

Results: Study ongoing, but VX445, Tezacaftor and Ivacaftor were found to be beneficial in CF and are now licensed for use in the UK as “Kaftrio”

 

Study title: Vertex NextGen programme

Status: Closed to recruitment, follow up ongoing

What is the study investigating? The long term safety and effectiveness of Tezacaftor, Ivacaftor and VX-445 (Triple therapy) in people with CF aged 12years+ firstly for either 4 or 24 weeks vs placebo, then over 96 weeks. The study has now been extended for an additional 96 weeks.

Results – VX-445, Tezacaftor and Ivacaftor were found to be beneficial in CF and are now licensed for use in the UK as “Kaftrio” https://investors.vrtx.com/news-releases/news-release-details/vertex-selects-triple-combination-regimen-vx-445-tezacaftor-and

 

Study Title:  ACTIF – Development and evaluation of an intervention to support adherence to treatment in adults with Cystic Fibrosis

Status – Complete

What is the study investigating? Does the CFHealthHub intervention increase adherence to nebulised medications?

Results – Awaited

 

Study Title: Vertex 106 and 108

Status – Complete

What is the study investigating? The safety and effectiveness of VX-661 (now known as Tezacaftor) and Ivacaftor vs placebo in people with CF aged 12years+ who are homozygous F508 (Vertex 106 study) and who have one copy of F508 and one residual function variant (Vertex 108)

Results – Tez/Iva was shown to increase lung function (FEV1) in participants and reduce the rate of exacerbations when compared to placebo.

More in depth results can be accessed here for Vertex 106 and Vertex 108.

This combination is being marketed as “Symkevi” in the UK.

 

Study title – VX14-661-110

Status – Complete

What is the study investigating? Long term safety and effectiveness of Tez/Iva in subjects who took part in Vertex 106/108 over 96 weeks

Results – TEZ/IVA was shown to be safe and beneficial for people with CF with qualifying genotypes and is currently marketed in the UK as “Symkevi”

 

Study title:  Hope-1 – Hydration for Optimal Pulmonary Effectiveness

Status: Complete

What is the study investigating? The effect of inhaled treatment SPX-101 over 4 weeks

Results: SPX-101 was not found to be beneficial compared to placebo.

Study title: NIHR CF Bioresource

Status: Opening October 2021

What is the purpose of the study? To research the link between genes, the environment, health and disease. This is done with lifestyle questionnaires, biological samples (blood and/or saliva) and future research.

Who can take part? There a specific cohort for people with Cystic Fibrosis Anyone – there are also cohorts for people with and without health problems.

What does it involve? A one-off visit with a lifestyle questionnaire and blood tests (can be saliva for children). You will also be asked to consent to being contacted about future research.

NIHR Bioresource already recruits to other disease areas, please follow this link for more information https://bioresource.nihr.ac.uk/

Principle investigator (CF Cohorts): Dr Phil Mitchelmore (Adults), Dr Beth Enderby (Paediatrics)

Contact: Sophie Whiteley s.whiteley1@nhs.net

 

Study title: CF STORM

Status: In set-up (paediatrics opening September 2021, adults late 2021)

What is the study investigating? To determine if nebulised mucolytics (hypertonic saline and/or pulmozyme) be safely stopped in people taking Kaftrio without a significant decline in lung function at 12 months

Who can take part? People with CF on Kaftrio and once daily mucolytics. There are also additional criteria to be assessed on study entry.

What does it involve? People who wish to take part are randomised (chosen at random by a computer) to either “STOP” or “CONTINUE” their nebulised mucolytics. There won’t be any extra hospital visits but your progress will be followed closely for 12 months. There are some additional questionnaires.

Primary Investigator: Dr Beth Enderby (paediatrics) and Dr Nick Withers (adults)

Contact: Sophie Whiteley s.whiteley1@nhs.net

 

 

Study title: TrIFIC “Targeting Immunotherapy for Fungal Infection in Cystic Fibrosis”

Status: In set up – opening late 2021

Observational study involving sample collection at routine visits only – more details soon

Primary investigator: Dr Phil Mitchelmore