RT Journal Article SR Electronic T1 Late Breaking Abstract - LUSTER-1 and -2: randomised controlled trials of fevipiprant in severe asthma JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 4614 DO 10.1183/13993003.congress-2020.4614 VO 56 IS suppl 64 A1 Christopher E. Brightling A1 Mina Gaga A1 Hiromasa Inoue A1 Jing Li A1 Jorge Maspero A1 Sally Wenzel A1 Somopriyo Maitra A1 David Lawrence A1 Florian Brockhaus A1 Thomas Lehmann A1 Caterina Brindicci A1 Barbara Knorr A1 Eugene Bleecker YR 2020 UL http://erj.ersjournals.com/content/56/suppl_64/4614.abstract AB Introduction: Fevipiprant, an oral, non-steroidal, highly selective, reversible antagonist of the PGD2 receptor 2, improved lung function and sputum eosinophil counts in asthma patients in Phase II clinical trials.Aim: To determine whether fevipiprant reduces exacerbation rates in patients with high blood eosinophils (≥250 cells/μl) and in all patients with severe asthma.Methods: LUSTER-1 and -2 were replicate, randomised, double-blind, placebo-controlled trials of fevipiprant added to GINA steps 4 & 5 therapy in patients ≥ 12 years. The primary objective was to compare moderate-to-severe asthma exacerbation rates of fevipiprant 150mg or 450mg o.d. with placebo over 52 weeks in both study populations. Pre-dose FEV1, ACQ-5 and AQLQ+12 were secondary endpoints, and post-bronchodilator FEV1 an exploratory endpoint, all at 52 weeks.Results: Patients in LUSTER-1 (n=894) and LUSTER-2 (n=877) received fevipiprant 150mg or 450mg o.d. or placebo. Rates of moderate-to-severe exacerbations were reduced compared with placebo (Table) although results were not statistically significant. Modest improvements in pre-dose and post-bronchodilator FEV1 were seen. There were no clinically meaningful differences in ACQ-5 and AQLQ+12. No safety or tolerability issues were noted.Conclusion: While not statistically significant, there were modest reductions in exacerbations and improvements in lung function for the higher dose of fevipiprant in both trials.FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 4614.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.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).