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W1025861901 abstract "LCI is a sensitive measure of ventilation distribution, reflecting abnormalities in smaller airways. The non-invasive technique is easy to perform, reproducible and increasingly being used in CF clinical trials. Variations in methodology prompted the CTN to undergo a standardisation process and establish a central Core Facility; our group at the Royal Brompton/ Imperial College London took on the latter role in July 2014. Equipment and methodology (Standard Operating Procedure: Multiple Breath Nitrogen Washout Exhalyzer® D Eco Medics AG. Version 1.0 Nov 11, 2013) are standardised. The purpose of the Core Facility is: 1.to assess traces (10 subjects, ≥3 traces each, ≥4 CF) submitted by member sites and ‘qualify' those meeting a predefined set of quality criteria, thus providing a pool of suitable sites available to sponsors; 2.to provide a centralised over-reading system, thus improving consistency of scoring and enabling the blind to be maintained at trial sites. To facilitate global trials, SOPs have been agreed in close alignment with corresponding investigators for N. America (Ratjen & Jensen, Toronto). In the 6 months since set up, the Core Facility has received submissions from 13 CTN sites. 5 have passed, 5 were required to resubmit, 2 have failed and one is under analysis. The main reason for failure is lack of experience and/ or adherence to the SOP. We are engaged with these sites to enable further training. The first commercially-sponsored clinical trial to run through this facility is open; another shortly to begin. By standardising and monitoring quality, we have the best chance of LCI performing to its optimal ability as a clinical trial outcome measure." @default.
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W1025861901 date "2015-06-01" @default.
W1025861901 modified "2023-09-28" @default.
W1025861901 title "WS21.9 Lung clearance index as a clinical trial outcome measure: Establishing the CTN LCI core facility" @default.
W1025861901 doi "https://doi.org/10.1016/s1569-1993(15)30129-6" @default.
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