Study Title: CF StartStatus: 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 for 48 months
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
Status – Closed to recruitment, follow up ongoing
What is the study investigating? Does the CFHealthHub intervention increase adherence to nebulised medications?
Results – Awaited
Status – Completed
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, but a reimbursement deal has not yet been agreed
Status – Closed to recruitment, follow up ongoing
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 – Awaited
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
Results – Full results not yet available but topline results have been released as a press release here
VX-445 has been named Elexacaftor and the triple therapy combination is being submitted for licensing in the US and in Europe later in 2019
Status: Complete
What is the study investigating? The effect of inhaled treatment SPX-101 over 4 weeks
Results: Awaited
Status: In set up – opening spring 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 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
Contact: Sophie Whiteley s.whiteley1@nhs.net
Status: In set up – opening Spring 2021
Observational study involving sample collection at routine visits only – more details soon
Primary investigator: Dr Phil Mitchelmore
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