As the CF population becomes increasingly healthier with the arrival of highly effective modulator therapy, more sensitive outcome measures will be needed and used more frequently in CF clinical trials looking to improve lung function.
Lung Clearance Index (LCI) is a sensitive measure of lung function and is becoming a more frequent outcome measure in CF clinical trials in both adults and children; however, LCI machines are considerably costly and require specialist training to use.
To meet this growing need, the Trust’s Trials Accelerator will use part of the recent £2.1 million funding from the Cystic Fibrosis Foundation (CFF) to provide Trial Accelerator centres across the UK with access to the necessary training and equipment needed to run clinical trials involving LCI.
Under the ‘LCI Training Package’, the Trust will purchase six LCI machines and train staff from participating CF centres in how to use the equipment and report the results required for clinical trials. Once staff are certified, the machines will be available for loan for clinical trial use at Trial Accelerator centres.
The generous funding from the CFF will help to further develop the most effective treatments for people affected by CF while staying up to date with the latest clinical trial advances.
Professor Jane Davies, honorary consultant in paediatric respiratory medicine at Royal Brompton & Harefield NHS Foundation Trust, said: "As LCI has become more commonly used as a trial read-out, it’s been frustrating for enthusiastic sites not yet LCI-ready to be excluded. The European CF Society established a Core facility run out of the Brompton centre to provide training and certification in nitrogen multibreath washout, which has led to great improvements in standardisation across the European CTN sites. We are delighted to now have the resources through CTAP to provide this support to other centres across the UK." Jane is also Chair of the Trials Accelerator Governance Board.
The LCI Training Package will commence in spring 2020 and take approximately one year to train staff from participating centres.
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