Evidence map›Paper›PMID 39286057›Full record

ArticleERJ open research2024

RLS-0071, a novel anti-inflammatory agent, significantly reduced inflammatory biomarkers in a randomised human evaluation of mechanisms and safety study.

Kenji Cunnion, Jessica Goss, Pamela Hair, Linda Dell, Destrey Roberson, Ulrich Thienel, Meike Müller, Saskia Carstensen-Aurèche, Philipp Badorrek, Olaf Holz and 1 more

Abstract read
In one paragraph

Article in ERJ open research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

11 authors.

Kenji CunnionDepartment of Research and Medical Affairs, ReAlta Life Sciences, Norfolk, VA, USA.
Jessica GossDepartment of Research and Medical Affairs, ReAlta Life Sciences, Norfolk, VA, USA.
Pamela HairDepartment of Research and Medical Affairs, ReAlta Life Sciences, Norfolk, VA, USA.
Linda DellDepartment of Research and Medical Affairs, ReAlta Life Sciences, Norfolk, VA, USA.
Destrey RobersonDepartment of Research and Medical Affairs, ReAlta Life Sciences, Norfolk, VA, USA.
Ulrich ThienelDepartment of Research and Medical Affairs, ReAlta Life Sciences, Norfolk, VA, USA.
Meike MüllerDivision of Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.
Saskia Carstensen-AurècheDivision of Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.
Philipp BadorrekDivision of Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.
Olaf HolzDivision of Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.ORCID https://orcid.org/0000-0003-0665-7807
Jens M HohlfeldDivision of Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.ORCID https://orcid.org/0000-0003-2646-6186

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: This study was a randomised, double-blind, placebo-controlled study intended to establish the translatability of the RLS-0071 mechanisms of action from animal disease models to humans by inhibiting neutrophil-mediated inflammation at the tissue level and major inflammatory biomarkers. We hypothesised that RLS-0071 inhibits a temporary neutrophil-mediated inflammation in the lungs induced by inhalation of low-dose lipopolysaccharide (LPS) in healthy participants. Methods: Participants were randomised to one of three arms to receive inhaled LPS followed by three doses of either low-dose (10 mg·kg Results: Active treatment with RLS-0071 showed a similar safety profile to participants receiving placebo. RLS-0071 significantly decreased the numbers of neutrophils in sputum at 6 h post LPS by approximately half (p=0.04). Neutrophil effectors myeloperoxidase, neutrophil elastase and interleukin-1β in sputum were also significantly decreased at 6 h for RLS-0071 compared with placebo. Several biomarkers showed trends suggesting sustained decreases for RLS-0071 Conclusion: This clinical trial demonstrated that RLS-0071 was safe and well tolerated and modulated neutrophil-mediated inflammation in humans after inhaled LPS challenge, consistent with results from prior animal model studies.

Identifiers

PMID39286057
PMCPMC11403592

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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.