The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network : An overview of Network organization, procedures, and interventions
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved..
Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. A current challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma.
| Errataetall: |
ErratumIn: J Allergy Clin Immunol. 2022 Aug;150(2):491. - PMID 35934682 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:149 |
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| Enthalten in: |
The Journal of allergy and clinical immunology - 149(2022), 2 vom: 01. Feb., Seite 488-516.e9 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Georas, Steve N [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 03.03.2022 Date Revised 19.04.2024 published: Print-Electronic ErratumIn: J Allergy Clin Immunol. 2022 Aug;150(2):491. - PMID 35934682 Citation Status MEDLINE |
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| doi: |
10.1016/j.jaci.2021.10.035 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM333852125 |
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| 245 | 1 | 4 | |a The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network |b An overview of Network organization, procedures, and interventions |
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| 500 | |a Date Completed 03.03.2022 | ||
| 500 | |a Date Revised 19.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ErratumIn: J Allergy Clin Immunol. 2022 Aug;150(2):491. - PMID 35934682 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. A current challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Review | |
| 650 | 4 | |a Severe asthma | |
| 650 | 4 | |a adaptive clinical trial design | |
| 650 | 4 | |a asthma exacerbation | |
| 650 | 4 | |a biomarker | |
| 650 | 4 | |a non–type 2 asthma | |
| 650 | 4 | |a patient advisory committee | |
| 650 | 4 | |a precision medicine | |
| 650 | 4 | |a type 2 asthma | |
| 650 | 7 | |a Biomarkers |2 NLM | |
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| 700 | 1 | |a Erzurum, Serpil C |e verfasserin |4 aut | |
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| 700 | 1 | |a James, John |e verfasserin |4 aut | |
| 700 | 1 | |a Jarjour, Nizar N |e verfasserin |4 aut | |
| 700 | 1 | |a Kenyon, Nicholas J |e verfasserin |4 aut | |
| 700 | 1 | |a Khatri, Sumita |e verfasserin |4 aut | |
| 700 | 1 | |a Kirwan, John P |e verfasserin |4 aut | |
| 700 | 1 | |a Kraft, Monica |e verfasserin |4 aut | |
| 700 | 1 | |a Krishnan, Jerry A |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Andrew H |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Mark C |e verfasserin |4 aut | |
| 700 | 1 | |a Marquis, M Alison |e verfasserin |4 aut | |
| 700 | 1 | |a Martinez, Fernando |e verfasserin |4 aut | |
| 700 | 1 | |a Mey, Jacob |e verfasserin |4 aut | |
| 700 | 1 | |a Moore, Wendy C |e verfasserin |4 aut | |
| 700 | 1 | |a Moy, James N |e verfasserin |4 aut | |
| 700 | 1 | |a Ortega, Victor E |e verfasserin |4 aut | |
| 700 | 1 | |a Peden, David B |e verfasserin |4 aut | |
| 700 | 1 | |a Pennington, Emily |e verfasserin |4 aut | |
| 700 | 1 | |a Peters, Michael C |e verfasserin |4 aut | |
| 700 | 1 | |a Ross, Kristie |e verfasserin |4 aut | |
| 700 | 1 | |a Sanchez, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Smith, Lewis J |e verfasserin |4 aut | |
| 700 | 1 | |a Sorkness, Ronald L |e verfasserin |4 aut | |
| 700 | 1 | |a Wechsler, Michael E |e verfasserin |4 aut | |
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| 700 | 1 | |a Pippins, Anna |e investigator |4 oth | |
| 700 | 1 | |a Rank, Matthew A |e investigator |4 oth | |
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| 700 | 1 | |a Baxi, Sachin N |e investigator |4 oth | |
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| 700 | 1 | |a Brick, Isabelle |e investigator |4 oth | |
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| 700 | 1 | |a Cinelli, Maria Angeles |e investigator |4 oth | |
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