Status: Open and recruiting new participants
What is the purpose of the study? To determine the effect yoga practice has on respiratory health-related quality of life for adults with CF.
Who can take part? People with CF aged over 16 who are currently stable, without any conditions which could stop them safely completing yoga. There are a number of criteria that will be checked by the research and clinical teams.
What does it involve? Three video calls over six months, plus online yoga for people allocated to the intervention
Primary Investigator: Dr Phil Mitchelmore
Contact: Sophie Whiteley s.whiteley1@nhs.net
Status: Open and recruiting
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 and future research.
Who can take part? There a specific cohort for people with Cystic Fibrosis, however anyone can take part as there are also cohorts for people with and without health conditions.
What does it involve? A one-off visit for blood tests. 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
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
Status: Closed to recruitment, follow up ongoing
What is the study investigating? Understanding patient adherence and supporting people with CF with their treatment adherence
Principle investigator: Dr Nick Withers
Contact: CF Physios Jayne and Cory rduh.exetercf@nhs.net
Status: Closed to recruitment, follow up ongoing
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
Principle Investigator: Dr Beth Enderby (paediatrics) and Dr Nick Withers (adults)
Contact: Sophie Whiteley s.whiteley1@nhs.net
Status: Closed to recruitment, follow up ongoing
What is the purpose of the study? To develop new immune system diagnostic tests to identify people with CF with abnormal immunity to fungi, and to identify abnormalities in the immune response to Aspergillus fumigatus in CF that have potential as targets for immunotherapy.
Principle Investigator: Dr Phil Mitchelmore
Contact: Sophie Whiteley s.whiteley1@nhs.net
Status: Closed to recruitment, follow up ongoing
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. Follow up continues until 4 years of age.
More info can be found at http://www.cfstart.org.uk/
Co-Investigators: Dr Beth Enderby and Dr Rachel Elderkin
Contact: Sophie Whiteley s.whiteley1@nhs.net
Status: Closed to recruitment, follow up ongoing
What is the study investigating? The long term safety and efficacy ofVX121/Tezacaftor/deuticaftor in people with CF aged 12+ who have minimal function genes
Principle Investigator: Dr Nick Withers
Contact: Sophie Whiteley s.whiteley1@nhs.net
Status: Closed
What is the study investigating? VX121/Tezacaftor/deuticaftor vs Kaftrio in people with CF aged 12+ who have minimal function genes
Results: Awaited
Status: Closed
What is the study investigating? Quality of life for children aged 6-11 who are prescribed modulators, and their parents/carers
Results: Awaited
Status: Complete
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: Not yet available as of July 2024
Status: Complete
What is the study investigating? The long term safety and effectiveness of Kaftrio in people with CF aged 12years+ over 96 weeks
Results: VX445, Tezacaftor and Ivacaftor were found to be beneficial in CF and are now licensed for use in the UK as “Kaftrio”
Status: Complete
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
Status – Complete
What is the study investigating? Does the CFHealthHub intervention increase adherence to nebulised medications?
Results – Awaited
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.
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”
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.
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