TY - JOUR T1 - DLco simulations for qualification of DLco devices globally for inhaled levodopa clinical trials JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2019.PA1133 VL - 54 IS - suppl 63 SP - PA1133 AU - Jason Blonshine AU - Susan Blonshine Y1 - 2019/09/28 UR - http://erj.ersjournals.com/content/54/suppl_63/PA1133.abstract N2 - Previously published studies describe a 25% DLco device failure rate on the first DLco simulator test then decreased failure rates over time (Jensen et al, Eur Respir J 2009; 33: 1-7).The study aim evaluates current DLco device failure rates at initial assessment and throughout 3 concurrent phase 3 clinical trials of CVT-301, inhaled levadopa. A pre-qualification process along with on-site training may decrease initial and subsequent DLco device failures during clinical trials.Methods: Pre-qualification forms were sent to sites to collect equipment type and purchase date. Study requirements stipulated 5 DLco device manufacturers at less than 8 years of age. 114 DLco devices were evaluated for accuracy prior to subject testing using the DLco simulator (Hans Rudolph, Kansas City, MO) during on-site training. Patient testing was simulated with 3 inspired volumes (3L, 4L, and 5L) and 2 gas ranges (Mid and High). 108 DLco devices were evaluated with simulations every 12-weeks from October 2014 to April 2018. Results were sent to TechEd for centralized calculation and review. Tests were acceptable if the DLco values were within ±10% of simulator expected target values. Only DLco devices within control limits were used for subject testing.Results: Initial DLco device failures occurred in 13(11.4%) of the 114 devices. The failure sources were inaccurate medical gas (46%), CO analyzers (46%) and software (8%). Post-training, 117 of 919 DLco simulations failed (12.7%), 56(51.9%) devices had zero failures, and 31(28.7%) had greater than one failure.Conclusion: Pre-qualification selection and on-site training led to fewer initial DLco device failures than previously reported in the literature.FootnotesCite this article as: European Respiratory Journal 2019; 54: Suppl. 63, PA1133.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only). ER -