1. The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions.
- Author
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Georas SN, Wright RJ, Ivanova A, Israel E, LaVange LM, Akuthota P, Carr TF, Denlinger LC, Fajt ML, Kumar R, O'Neal WK, Phipatanakul W, Szefler SJ, Aronica MA, Bacharier LB, Burbank AJ, Castro M, Crotty Alexander L, Bamdad J, Cardet JC, Comhair SAA, Covar RA, DiMango EA, Erwin K, Erzurum SC, Fahy JV, Gaffin JM, Gaston B, Gerald LB, Hoffman EA, Holguin F, Jackson DJ, James J, Jarjour NN, Kenyon NJ, Khatri S, Kirwan JP, Kraft M, Krishnan JA, Liu AH, Liu MC, Marquis MA, Martinez F, Mey J, Moore WC, Moy JN, Ortega VE, Peden DB, Pennington E, Peters MC, Ross K, Sanchez M, Smith LJ, Sorkness RL, Wechsler ME, Wenzel SE, White SR, Zein J, Zeki AA, and Noel P
- Subjects
- Advisory Committees, Asthma diagnosis, Biomarkers, Clinical Protocols, Clinical Trials, Phase II as Topic, Humans, Research Design, Severity of Illness Index, Tomography, X-Ray Computed, Asthma drug therapy, Precision Medicine
- Abstract
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., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
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