Evidence map›Paper›PMID 27806191›Full record

Trial reportClinical and translational science2017

Phase I Studies of Acebilustat: Biomarker Response and Safety in Patients with Cystic Fibrosis.

J S Elborn, A Horsley, G MacGregor, D Bilton, R Grosswald, S Ahuja, E B Springman

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–field-weighted citation impact
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

20 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Trial
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. CFTR Modulators DampenFrontiers in cellular and infection microbiology · 2020
    Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Leukotriene biosynthetic enzymes as therapeutic targets.The Journal of clinical investigation · 2018
    Review
  19. Article
  20. Review
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

7 authors.

J S ElbornCentre for Infection and Immunity, Dentistry, and Biomedical Sciences, Queens University School of Medicine, Belfast, UK.
A HorsleyCentre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, University of Manchester, Manchester, UK.
G MacGregorWest of Scotland CF Centre, Gartnavel General Hospital, Glasgow, UK.
D BiltonDepartment of Respiratory Medicine, Royal Brompton Hospital, London, UK.
R GrosswaldCeltaxsys, Inc, Atlanta, Georgia, USA.
S AhujaCeltaxsys, Inc, Atlanta, Georgia, USA.
E B SpringmanCeltaxsys, Inc, Atlanta, Georgia, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is a significant unmet need for safe and effective anti-inflammatory treatment for cystic fibrosis. The aim of this study was to evaluate the safety of acebilustat, a leukotriene A4 hydrolase inhibitor, and its effect on inflammation biomarkers in patients with cystic fibrosis. Seventeen patients with mild to moderate cystic fibrosis were enrolled and randomized into groups receiving placebo or doses of 50 mg or 100 mg acebilustat administered orally, once daily for 15 days. Sputum neutrophil counts were reduced by 65% over baseline values in patients treated with 100 mg acebilustat. A modestly significant 58% reduction vs. placebo in sputum elastase was observed with acebilustat treatment. Favorable trends were observed for reduction of serum C-reactive protein and sputum neutrophil DNA in acebilustat-treated patients. No changes in pulmonary function were observed. Acebilustat was safe and well tolerated. The results of this study support further clinical development of acebilustat for treatment of cystic fibrosis.

Indexed as

AdultAzabicyclo CompoundsBenzoatesBiomarkersColony Count, MicrobialCystic FibrosisDNAFemaleHumansInflammationLeukocyte CountLungMalePancreatic ElastaseRespiratory Function TestsSputumacebilustatAzabicyclo CompoundsBenzoatesBiomarkersDNAPancreatic Elastase

Identifiers

PMID27806191
PMCPMC5351012

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.