Evidence map›Paper›PMID 34538755›Full record

Trial reportJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2021

Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis.

J Stuart Elborn, Michael W Konstan, Jennifer L Taylor-Cousar, Isabelle Fajac, Alexander Horsley, Sivagurunathan Sutharsan, Shawn D Aaron, Cori L Daines, Ahmet Uluer, Damian G Downey and 7 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Targeting neutrophil serine proteases in bronchiectasis.The European respiratory journal · 2025
    Review
  6. Review
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 5 countries.

J Stuart ElbornFaculty of Medicine Health and Life sciences Queens University School of Medicine, Belfast, UK.
Michael W KonstanDepartment of Pediatrics, Case Western Reserve University School of Medicine and Rainbow Babies & Children's Hospital, Cleveland, OH, USA.
Jennifer L Taylor-CousarDepartments of Medicine and Pediatrics, National Jewish Health, Denver, CO, USA.
Isabelle FajacPhysiology Department, Cochin Hospital, APHP Centre, Paris, France; Université de Paris, Paris, France.
Alexander HorsleyDivision of Infection, Immunity and Respiratory Medicine, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Sivagurunathan SutharsanDivision of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine EssenRuhrlandklinik, University of DuisburgEssen, Essen, Germany.
Shawn D AaronOttawa Health Research Institute, Ottawa, Ontario, Canada.
Cori L DainesDepartment of Pediatrics, University of Arizona, Tucson, AZ, USA.
Ahmet UluerDepartment of Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
Damian G DowneyWellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK.
Vincenzina V LucidiCystic Fibrosis Center, Children's Hospital and Research Institute, Bambino Gesu, Rome, Italy.
Sanjeev AhujaCeltaxsys, Inc., Atlanta, GA, USA.
Eric SpringmanCeltaxsys, Inc., Atlanta, GA, USA.
John MershonCeltaxsys, Inc., Atlanta, GA, USA.
Ralph GrosswaldCeltaxsys, Inc., Atlanta, GA, USA.
Steven M RoweGregory Fleming James Cystic Fibrosis Research Center and Department of Medicine, University of Alabama at Birmingham, 1918 University Blvd, MCLM 804, Birmingham 35294, AL, USA. Electronic address: smrowe@uab.edu.
EMPIRE-CF study group
Queen's University Belfast · GBBambino Gesù Children's Hospital · ITBoston Children's Hospital · USNational Jewish Health · USRainbow Babies & Children's Hospital · USRuhrlandklinik · DEUniversité Paris Cité · FRUniversity of Alabama at Birmingham · USUniversity of Arizona · USUniversity of Manchester · GB

Funding

National Dissemination of I-Corps@NCATS: Accelerating Translation through CommercializationUL1TR003096 · NCATS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GUTIERREZ, ORLANDO M, KIMBERLY, ROBERT P. · 2019 to 2023
$43.6M
Clinical and Translational Science Collaborative of ClevelandUL1TR002548 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2018 to 2022
$35.5M
UAB CF Research and Translation Core CenterP30DK072482 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Brian R. Davis · 2007 to 2026
$23.0M
Translational Program in CFTR-Related Airway DiseasesR35HL135816 · NHLBI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI ROWE, STEVEN MARK · 2017 to 2022
$6.3M
Department of HealthNCATS NIH HHS UL1 TR002548NCATS NIH HHS UL1 TR003096NHLBI NIH HHS R35 HL135816NIDDK NIH HHS P30 DK072482
6 · The paper itself

Abstract

backgroundCystic fibrosis (CF) is characterized by neutrophilic inflammation in the airways. Leukotriene B4 (LTB

methodsSubjects 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 (ppFEV

resultsOverall, 199 subjects were randomized and dosed (acebilustat 50 mg, n=67; acebilustat 100 mg, n=66; placebo, n=66). Baseline demographics and disease profile were well balanced among treatment groups. Acebilustat had no statistically significant effect on the primary endpoint of change in ppFEV

conclusionsAcebilustat did not improve lung function. A trend towards reduced pulmonary exacerbations in subjects with an earlier stage of lung disease suggests a potential effect in this population.

Indexed as

AdolescentAdultAzabicyclo CompoundsBenzoatesCystic FibrosisDouble-Blind MethodEpoxide HydrolasesFemaleHumansMaleRespiratory Function TestsSeverity of Illness IndexacebilustatAzabicyclo CompoundsBenzoatesEpoxide Hydrolasesleukotriene A4 hydrolaseCFTRCystic fibrosisInflammationLTA4HLTB(4)Neutrophils

Identifiers

PMID34538755
PMCPMC8649042
OpenAlexW3199957072

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.