1. The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions
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Steve N. Georas, Rosalind J. Wright, Anastasia Ivanova, Elliot Israel, Lisa M. LaVange, Praveen Akuthota, Tara F. Carr, Loren C. Denlinger, Merritt L. Fajt, Rajesh Kumar, Wanda K. O’Neal, Wanda Phipatanakul, Stanley J. Szefler, Mark A. Aronica, Leonard B. Bacharier, Allison J. Burbank, Mario Castro, Laura Crotty Alexander, Julie Bamdad, Juan Carlos Cardet, Suzy A.A. Comhair, Ronina A. Covar, Emily A. DiMango, Kim Erwin, Serpil C. Erzurum, John V. Fahy, Jonathan M. Gaffin, Benjamin Gaston, Lynn B. Gerald, Eric A. Hoffman, Fernando Holguin, Daniel J. Jackson, John James, Nizar N. Jarjour, Nicholas J. Kenyon, Sumita Khatri, John P. Kirwan, Monica Kraft, Jerry A. Krishnan, Andrew H. Liu, Mark C. Liu, M. Alison Marquis, Fernando Martinez, Jacob Mey, Wendy C. Moore, James N. Moy, Victor E. Ortega, David B. Peden, Emily Pennington, Michael C. Peters, Kristie Ross, Maria Sanchez, Lewis J. Smith, Ronald L. Sorkness, Michael E. Wechsler, Sally E. Wenzel, Steven R. White, Joe Zein, Amir A. Zeki, Patricia Noel, Dean Billheimer, Eugene R. Bleecker, Emily Branch, Michelle Conway, Cori Daines, Isaac Deaton, Alexandria Evans, Paige Field, Dave Francisco, Annette T. Hastie, Bob Hmieleski, Jeffrey O. Krings, Yanqin Liu, Janell L. Merchen, Deborah A. Meyers, Nirushan Narendran, Stephen P. Peters, Anna Pippins, Matthew A. Rank, Ronald Schunk, Raymond Skeps, Benjamin Wright, Tina M. Banzon, Lisa M. Bartnikas, Sachin N. Baxi, Vishwanath Betapudi, Isabelle Brick, Conor Brockway, Thomas B. Casale, Kathleen Castillo-Ruano, Maria Angeles Cinelli, Elena Crestani, Amparito Cunningham, Megan Day-Lewis, Natalie Diaz-Cabrera, Angela DiMango, Brittany Esty, Eva Fandozzi, Jesse Fernandez, Elizabeth Fitzpatrick, Victoria E. Forth, Katarina Gentile, David Gubernick, Seyni Gueye-Ndiaye, Sigfus Gunnlaagsson, Marissa Hauptmann, Stephanie N. Hudey, Donya S. Imanirad, Tiffani Kaage, Nicholas Kolinsky, Brenna LaBere, Peggy Sue Lai, Meghan Le, Dennis K. Ledford, Richard Lockey, Margee Louisias, Andrew J. Macginnitie, Michelle C. Maciag, Allison O’Neill, Amber N. Pepper, Perdita Permaul, Mya Pugh, Dianna Queheillalt, Tarnjot Saroya, William Sheehan, Catherine Smith, Carmela Socolovsky, Else Treffeisen, Lorenzo Trippa, Abigail Tulchinsky, Christina Yee, Tina Carter, Jun Fu, Vanessa Garcia, Jenny Hixon, Carly Jackson, Yuan Ji, Ravi Kalhan, Opinderjit Kaur, Grace Li, Melanie M. Makhija, Spring Maleckar, Edward T. Naureckas, Anju T. Peters, Valerie Press, Mehreen Qureshi, Paul A. Reyfman, Sharon R. Rosenberg, Dominika Ryba, Jianrong Sheng, Ben Xu, Rafeul Alam, Darci Anderson, Sonya Belimezova, Jennifer Bitzan, Geoffrey Chupp, Brian J. Clark, Lauren Cohn, Margaret Hope Cruse, Jean Estrom, Leah Freid, Jose Gomez Villalobos, Nicole Grant, Vamsi P. Guntur, Carole Holm, Christena Kolakowski, Laurie A. Manka, Naomi Miyazawa, Juno Pak, Diana M. Pruitt, Sunita Sharma, Allen D. Stevens, Kisori Thomas, Brooke Tippin, Karissa Valente, Cynthia L. Wainscoat, Michael P. White, Daniel Winnica, Shuyu Ye, Pamela L. Zeitlin, Julia Bach, Joshua Brownell, Lauren Castro, Julie DeLisa, Sean B. Fain, Paul S. Fichtinger, Heather Floerke, James E. Gern, Vinay Goswamy, Jenelle Grogan, Wendy Hasse, Rick L. Kelley, Danika Klaus, Stephanie LaBedz, Paige Lowell, Andrew Maddox, Sameer K. Mathur, Amanda McIntyre, Lourdes M. Norwick, Sharmilee M. Nyenhuis, Matthew J. O’Brien, Tina Palas, Andrea A. Pappalardo, Mark Potter, Sima K. Ramratnam, Daniel L. Rosenberg, Eric M. Schauberger, Mark L. Schiebler, Angela Schraml, Mohamed Taki, Matthew C. Tattersall, Jissell Torres, Lori Wollet, Simon Abi-Saleh, Lisa Bendy, Larry Borish, James F. Chmiel, Aska Dix, Lisa France, Rebecca Gammell, Adam Gluvna, Brittany Hirth, Bo Hu, Elise Hyser, Kirsten M. Kloepfer, Michelle Koo, Nadia L. Krupp, Monica Labadia, Joy Lawrence, Laurie Logan, Angela Marko, Brittany Matuska, Deborah Murphy, Rachel Owensby, Erica A. Roesch, Don B. Sanders, Jackie Sharp, W. Gerald Teague, Laura Veri, Kristin Wavell Shifflett, Matt Camiolo, Sarah Collins, Jessa Demas, Courtney Elvin, Marc C. Gauthier, Melissa Ilnicki, Jenn Ingram, Lisa Lane, Seyed Mehdi Nouraie, John B. Trudeau, Michael Zhang, Jeffrey Barry, Howard Brickner, Janelle Celso, Matejka Cernelc-Kohan, Damaris Diaz, Ashley Du, Sonia Jain, Neiman Liu, Yusife Nazir, Julie Ryu, Pandurangan Vijayanand, Rogelio Almario, Ariana Baum, Kellen Brown, Marilynn H. Chan, Barbara Gale, Angela Haczku, Richart W. Harper, Raymond Heromin, Celeste Kivler, Brooks T. Kuhn, Ngoc P. Ly, Paula McCourt, Xavier Orain, Audrey Plough, Karla Ramirez, Ellese Roberts, Michael Schivo, Amisha Singapuri, Tina Tham, Daniel Tompkins, Patricia Michelle Twitmyer, Jade Vi, Jarron Atha, Jennifer Bedard, Jonathan S. Boomer, Andrew Chung, Vanessa Curtis, Chase S. Hall, Emily Hart, Fatima Jackson, Pamela Kemp, Sharli Maxwell, Maggie Messplay, Crystal Ramirez, Brynne Thompson, Ashley Britt, Hope Bryan, Nathan M. Gotman, Yue Jiang, Michael R. Kosorok, David T. Mauger, Kelsey Meekins, Jeanette K. Mollenhauer, Sarah Moody, Cheyanne Ritz, Stefanie Schwartz, Chalmer Thomlinson, and Nicole Wilson
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Severe asthma ,Exacerbation ,Allergy ,Disease ,non-type 2 asthma ,Severity of Illness Index ,asthma exacerbation ,Clinical Protocols ,Immunology and Allergy ,Precision Medicine ,Tomography ,Lung ,education.field_of_study ,X-Ray Computed ,Asthma Control Questionnaire ,Research Design ,Respiratory ,biomarker ,medicine.medical_specialty ,precision medicine ,Population ,Advisory Committees ,Clinical Trials and Supportive Activities ,Immunology ,patient advisory committee ,Natural history of disease ,Article ,Clinical Trials, Phase II as Topic ,Clinical Research ,medicine ,Humans ,type 2 asthma ,Clinical Trials ,Intensive care medicine ,education ,PrecISE Study Team ,Disease burden ,Asthma ,adaptive clinical trial design ,non–type 2 asthma ,business.industry ,Phase II as Topic ,medicine.disease ,Precision medicine ,respiratory tract diseases ,Good Health and Well Being ,business ,Tomography, X-Ray Computed ,Biomarkers - 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. Acurrent 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.
- Published
- 2022