Evidence map›Paper›PMID 25195169›Full record

Trial reportThe Journal of allergy and clinical immunology2015

IL-1 receptor antagonist reduces endotoxin-induced airway inflammation in healthy volunteers.

Michelle L Hernandez, Katherine Mills, Martha Almond, Krista Todoric, Maria M Aleman, Hongtao Zhang, Haibo Zhou, David B Peden

4 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 60 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 4% 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.

NCT03513458 phase1 / phase2withdrawnnot on this mapstarted 2020, after this paper: background citation

Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2020 to 2021Enrolled0ConditionsAsthmaArmsAnakinra, Anakinra Matching Placebo, Dermatophagoides Farinae
NCT03513471 phase1 / phase2withdrawnnot on this mapstarted 2019, after this paper: background citation

Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2019 to 2021Enrolled0ConditionsAsthmaArmsAnakinra, Anakinra Matching Placebo, Dermatophagoides Farinae
NCT03851406 nacompletednot on this mapstarted 2019, after this paper: background citation

Phase I/II Randomized Cross-over Study of Hypertonic Saline on Airway Inflammatory Response to Inhaled Wood Smoke

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2019 to 2024Enrolled9ConditionsAirway InflammationArms5% Hypertonic Saline, No treatment
NCT03861390 phase1 / phase2completednot on this mapstarted 2019, after this paper: background citation

Phase I/II Randomized, Double-blind, Placebo-controlled Cross-over Study of Prednisone on Airway Inflammatory Response to Inhaled Wood Smoke

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2019 to 2023Enrolled12ConditionsAirway InflammationArms60 mg Prednisone, Placebo
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 2 syntheses or guidelines pooled it, 102 citations in OpenAlex.

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  17. Innate immune responses are increased in children with acute asthma exacerbation.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2024
    Article
  18. New targets for type 2-low asthma.The Korean journal of internal medicine · 2024
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Michelle L HernandezCenter for Environmental Medicine, Asthma, & Lung Biology, University of North Carolina, Chapel Hill, NC. Electronic address: michelle_hernandez@med.unc.edu.
Katherine MillsCenter for Environmental Medicine, Asthma, & Lung Biology, University of North Carolina, Chapel Hill, NC.
Martha AlmondCenter for Environmental Medicine, Asthma, & Lung Biology, University of North Carolina, Chapel Hill, NC.
Krista TodoricCenter for Environmental Medicine, Asthma, & Lung Biology, University of North Carolina, Chapel Hill, NC.
Maria M AlemanCenter for Environmental Medicine, Asthma, & Lung Biology, University of North Carolina, Chapel Hill, NC.
Hongtao ZhangDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.
Haibo ZhouDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.
David B PedenCenter for Environmental Medicine, Asthma, & Lung Biology, University of North Carolina, Chapel Hill, NC.
University of North Carolina at Chapel Hill · US

Funding

UNC-CH CENTER FOR ENVIRONMENTAL HEALTH &SUSCEPTIBILITYP30ES010126 · NIEHS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Melissa A. Troester · 2001 to 2026
$36.3M
P2X7 and the Inflammasome Pathways in Lung InflammationU19AI077437 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI PEDEN, DAVID B. · 2008 to 2013
$9.2M
Down-regulation of oxidant-induced airway inflammation though modulation of NRF2K23ES021745 · NIEHS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HERNANDEZ, MICHELLE · 2012 to 2014
$612k
NIAID NIH HHS U19 AI077437NIAID NIH HHS U19AI077437NIEHS NIH HHS K23 ES021745NIEHS NIH HHS P30 ES010126
6 · The paper itself

Abstract

backgroundAsthma with neutrophil predominance is challenging to treat with corticosteroids. Novel treatment options for asthma include those that target innate immune activity. Recent literature has indicated a significant role for IL-1β in both acute and chronic neutrophilic asthma.

objectiveThis study used inhaled endotoxin (LPS) challenge as a model of innate immune activation to (1) assess the safety of the IL-1 receptor antagonist anakinra in conjunction with inhaled LPS and (2) to test the hypothesis that IL-1 blockade will suppress the acute neutrophil response to challenge with inhaled LPS.

methodsIn a phase I clinical study 17 healthy volunteers completed a double-blind, placebo-controlled crossover study in which they received 2 daily subcutaneous doses of 1 mg/kg anakinra (maximum dose, 100 mg) or saline (placebo). One hour after the second treatment dose, subjects underwent an inhaled LPS challenge. Induced sputum was assessed for neutrophils 4 hours after inhaled LPS. The effect of anakinra compared with placebo on airway neutrophil counts and airway proinflammatory cytokine levels after LPS challenge was compared by using a linear mixed-model approach.

resultsAnakinra pretreatment significantly diminished airway neutrophilia compared with placebo. LPS-induced IL-1β, IL-6, and IL-8 levels were significantly reduced during the anakinra treatment period compared with those seen after placebo. Subjects tolerated the anakinra treatment well without an increased frequency of infections attributable to anakinra treatment.

conclusionsAnakinra effectively reduced airway neutrophilic inflammation and resulted in no serious adverse events in a model of inhaled LPS challenge. Anakinra is a potential therapeutic candidate for treatment of asthma with neutrophil predominance in diseased populations.

Indexed as

Administration, InhalationAdultAnti-Inflammatory AgentsCross-Over StudiesCytokinesEndotoxinsFemaleHealthy VolunteersHumansInflammationInflammation MediatorsInterleukin 1 Receptor Antagonist ProteinLeukocyte CountLipopolysaccharidesMaleNeutrophil InfiltrationAnti-Inflammatory AgentsCytokinesEndotoxinsInflammation MediatorsInterleukin 1 Receptor Antagonist ProteinLipopolysaccharidesReceptors, Interleukin-1anakinraasthmaEndotoxinIL-1 receptor antagonistIL-1βinduced sputuminnate immunityLPSneutrophil

Identifiers

PMID25195169
PMCPMC4323893
OpenAlexW1972063595

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.