Evidence map›Paper›PMID 35123074›Full record

Trial reportAnnals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology2022

Treatment by biomarker-informed endotype vs guideline care in children with difficult-to-treat asthma.

Theresa W Guilbert, Jocelyn M Biagini, Rachelle R Ramsey, Kristina Keidel, Kristi Curtsinger, John W Kroner, Sandy R Durrani, Mariana Stevens, Valentina Pilipenko, Lisa J Martin and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04179461 (Personalized Treatment Algorithms for Difficult-to-treat Asthma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04179461 phase2completednot on this map

Personalized Treatment Algorithms for Difficult-to-treat Asthma: Bench to Community

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2018 to 2019Enrolled21ConditionsAsthma in ChildrenArmsCholecalciferol, antihistamine, Azithromycin, emollient cream, Fluticasone Propionate
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

13 authors.

Theresa W GuilbertDivision of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Jocelyn M BiaginiDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Rachelle R RamseyDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Kristina KeidelDivision of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Kristi CurtsingerDivision of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
John W KronerDivision of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Sandy R DurraniDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Mariana StevensDivision of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Valentina PilipenkoDivision of Human Genetics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Lisa J MartinDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Human Genetics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Carolyn M KercsmarDivision of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Kevin HommelDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Gurjit K Khurana HersheyDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: Gurjit.Hershey@cchmc.org.

Funding

LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI HEUBI, JAMES E., KISSELA, BRETT M · 2015 to 2024
$37.5M
Using technology-assisted stepped-care interventions to improve adherence in adolescents with asthmaK23HL139992 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI RAMSEY, RACHELLE R. · 2019 to 2023
$868k
NCATS NIH HHS UL1 TR001425NHLBI NIH HHS K23 HL139992
6 · The paper itself

Abstract

backgroundAsthma is heterogeneous, contributing to difficulty in disease management.

objectiveTo develop a biomarker-informed treatment model for difficult-to-treat (DTT) asthma and conduct a pilot feasibility study.

methodsSchool-aged children (n = 21) with DTT asthma were enrolled and completed 3 medical visits (V1-V3). V2 and V3 were completed approximately 3.5 months and 12 months after V1, respectively. At V1, guideline care and adherence interventions were initiated, and blood samples were collected for asthma biomarker assessment. A personalized treatment algorithm was developed based on biomarkers (treatment by endotype) and was implemented at V2. Asthma outcomes were compared from V1 to V2 (guideline-based care) to V2 to V3 (guideline + biomarker-informed care).

resultsOverall retention was 86%. There was an even distribution of participants with allergy, without allergy, and with mixed allergies. The participants received an average of 5.9 interventions (range, 3-9). The allergic phenotype was characterized by increased CDHR3 risk genotype and high transepidermal water loss. High serum interleukin-6 level was most notable in the mixed allergic subgroup. The nonallergic phenotype was characterized by vitamin D deficiency and poor steroid treatment responsiveness. The personalized treatment plans were associated with decreased emergency department visits (median, 1 vs 0; P = .04) and increased asthma control test scores (median, 22.5 vs 23.0; P = .01).

conclusionThe biomarker-based treatment algorithm triggered interventions on top of guideline care in all children with DTT asthma studied, supporting the need for this type of multipronged approach. Our findings identify the minimal biomarker set that is informative, reveal that this treatment-by-endotype intervention is feasible and may be superior to guideline care alone, and provide a strong foundation for a definitive trial.

trial registrationClinicalTrials.gov identifier: NCT04179461.

Indexed as

AsthmaHypersensitivityBiomarkersCadherin Related ProteinsCadherinsChildEmergency Service, HospitalHumansMembrane ProteinsPhenotypeBiomarkersCadherin Related ProteinsCadherinsCDHR3 protein, humanMembrane Proteins

Identifiers

PMID35123074
PMCPMC9125694

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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.