Related Experiment Video
Updated: Sep 9, 2025
Employing the Forced Oscillation Technique for the Assessment of Respiratory Mechanics in Adults
Published on: February 9, 2022
Spirometry thresholds for clinical trial eligibility: time for urgent re-evaluation
Idan Bokobza1,2,3, Melanie Le Sayec2,4, Cara Bossley2,4
1National Heart and Lung Institute, Imperial College London, London, UK.
Abstract:
A common eligibility criterion in respiratory clinical trials is a per cent-predicted forced expiratory volume in 1 second (ppFEV1) between 40% and 90%, using the ethnicity-dependent Global Lung Function Initiative (GLI)-2012 spirometry reference equations. International societies now endorse the newer 'race-neutral' GLI-Global equations. We quantify the impact on trial eligibility of switching from GLI-2012 to GLI-Global for the UK Cystic Fibrosis Registry (n=8182). In a future trial with a maximum eligibility threshold of ppFEV1=90%, the changes in ppFEV1 would lead to over 700 people becoming newly ineligible. Urgent review of fixed ppFEV1 thresholds is required, with an initial recommendation to widen the range to 30-95% ppFEV1 when GLI-Global is implemented to ensure equitable access for people of all ethnicities. There is also a wider need to review the use of fixed ppFEV1 spirometry limits for trial eligibility.
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