Late Breaking Abstract - LUSTER-1 and -2: randomised controlled trials of fevipiprant in severe asthma

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.