{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Elborn JS"],"funding":["NCATS NIH HHS","NIDDK NIH HHS","NHLBI NIH HHS","National Institute for Health Research (NIHR)"],"pagination":["1026-1034"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8649042"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["20(6)"],"pubmed_abstract":["<h4>Background</h4>Cystic fibrosis (CF) is characterized by neutrophilic inflammation in the airways. Leukotriene B4 (LTB<sub>4</sub>) is a neutrophil chemoattractant and has been implicated in CF pathogenesis. Acebilustat, a novel, synthetic, small-molecule leukotriene A4 hydrolase inhibitor, reduces LTB<sub>4</sub> production. We report findings from a randomized placebo-controlled trial of acebilustat in adult subjects with mild-to-moderate lung disease.<h4>Methods</h4>Subjects were randomized (1:1:1) to once-daily acebilustat 50 mg, 100 mg or placebo for 48 weeks, concomitantly with their current therapeutic regimen. Subjects were stratified by use of concomitant CF transmembrane conductance regulator (CFTR) modulators, baseline percent predicted forced expiratory volume in 1 second (p"],"journal":["Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society"],"pubmed_title":["Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis."],"pmcid":["PMC8649042"],"funding_grant_id":["R35 HL135816","UL1 TR002548","UL1 TR003096","P30 DK072482"],"pubmed_authors":["Aaron SD","Grosswald R","Mershon J","Fajac I","Springman E","EMPIRE-CF study group","Konstan MW","Rowe SM","Lucidi VV","Elborn JS","Uluer A","Taylor-Cousar JL","Sutharsan S","Ahuja S","Downey DG","Horsley A","Daines CL"],"additional_accession":[]},"is_claimable":false,"name":"Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis.","description":"<h4>Background</h4>Cystic fibrosis (CF) is characterized by neutrophilic inflammation in the airways. Leukotriene B4 (LTB<sub>4</sub>) is a neutrophil chemoattractant and has been implicated in CF pathogenesis. Acebilustat, a novel, synthetic, small-molecule leukotriene A4 hydrolase inhibitor, reduces LTB<sub>4</sub> production. We report findings from a randomized placebo-controlled trial of acebilustat in adult subjects with mild-to-moderate lung disease.<h4>Methods</h4>Subjects were randomized (1:1:1) to once-daily acebilustat 50 mg, 100 mg or placebo for 48 weeks, concomitantly with their current therapeutic regimen. Subjects were stratified by use of concomitant CF transmembrane conductance regulator (CFTR) modulators, baseline percent predicted forced expiratory volume in 1 second (p","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Nov","modification":"2026-05-08T01:51:14.487Z","creation":"2025-02-19T04:20:23.047Z"},"accession":"S-EPMC8649042","cross_references":{"pubmed":["34538755"],"doi":["10.1016/j.jcf.2021.08.007"]}}