학술논문

The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions
Document Type
article
Author
Georas, Steve NWright, Rosalind JIvanova, AnastasiaIsrael, ElliotLaVange, Lisa MAkuthota, PraveenCarr, Tara FDenlinger, Loren CFajt, Merritt LKumar, RajeshO’Neal, Wanda KPhipatanakul, WandaSzefler, Stanley JAronica, Mark ABacharier, Leonard BBurbank, Allison JCastro, MarioAlexander, Laura CrottyBamdad, JulieCardet, Juan CarlosComhair, Suzy AACovar, Ronina ADiMango, Emily AErwin, KimErzurum, Serpil CFahy, John VGaffin, Jonathan MGaston, BenjaminGerald, Lynn BHoffman, Eric AHolguin, FernandoJackson, Daniel JJames, JohnJarjour, Nizar NKenyon, Nicholas JKhatri, SumitaKirwan, John PKraft, MonicaKrishnan, Jerry ALiu, Andrew HLiu, Mark CMarquis, M AlisonMartinez, FernandoMey, JacobMoore, Wendy CMoy, James NOrtega, Victor EPeden, David BPennington, EmilyPeters, Michael CRoss, KristieSanchez, MariaSmith, Lewis JSorkness, Ronald LWechsler, Michael EWenzel, Sally EWhite, Steven RZein, JoeZeki, Amir ANoel, PatriciaBillheimer, DeanBleecker, Eugene RBranch, EmilyConway, MichelleDaines, CoriDeaton, IsaacEvans, AlexandriaField, PaigeFrancisco, DaveHastie, Annette THmieleski, BobKrings, Jeffrey OLiu, YanqinMerchen, Janell LMeyers, Deborah ANarendran, NirushanPeters, Stephen PPippins, AnnaRank, Matthew ASchunk, RonaldSkeps, RaymondWright, BenjaminBanzon, Tina MBartnikas, Lisa MBaxi, Sachin NBetapudi, VishwanathBrick, IsabelleBrockway, ConorCasale, Thomas BCastillo-Ruano, KathleenCinelli, Maria AngelesCrestani, ElenaCunningham, AmparitoDay-Lewis, MeganDiaz-Cabrera, NatalieDiMango, AngelaEsty, BrittanyFandozzi, EvaFernandez, JesseFitzpatrick, Elizabeth
Source
Journal of Allergy and Clinical Immunology. 149(2)
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Lung
Clinical Research
Clinical Trials and Supportive Activities
Asthma
Respiratory
Good Health and Well Being
Advisory Committees
Biomarkers
Clinical Protocols
Clinical Trials
Phase II as Topic
Humans
Precision Medicine
Research Design
Severity of Illness Index
Tomography
X-Ray Computed
Severe asthma
precision medicine
adaptive clinical trial design
asthma exacerbation
type 2 asthma
non-type 2 asthma
patient advisory committee
biomarker
PrecISE Study Team
non–type 2 asthma
Immunology
Allergy
Language
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.