ArticleThe Journal of allergy and clinical immunology2021
PrecISE: Precision Medicine in Severe Asthma: An adaptive platform trial with biomarker ascertainment.
Open access · greenAbstract read
In one paragraph
Article in The Journal of allergy and clinical immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 6% of its field
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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Methodology and design of platform trials: a meta-epidemiological study.Journal of clinical epidemiology · 2023Pooled it
- Individualized interventions and precision health: Lessons learned from a systematic review and implications for analytics-driven geriatric research.Journal of the American Geriatrics Society · 2023Pooled it
- PrecISE-a biomarker-stratified adaptive trial of 5 interventions in severe asthma: Final protocol and the baseline cohort.The Journal of allergy and clinical immunology · 2026Trial
- Evolution, hotspots, and future directions of artificial intelligence in asthma research: a Web of Science-based bibliometric analysis [2016-2026].Journal of thoracic disease · 2026Article
- Review
- Emerging Systemic Treatments for Asthma and Allergic Diseases: New Tricks, Same Dog?The journal of allergy and clinical immunology. In practice · 2026Review
- Toward precision for bronchopulmonary dysplasia: Moving past current definitions.Journal of perinatology : official journal of the California Perinatal Association · 2026Review
- Targeting neutrophil extracellular traps: an emerging strategy for improving the management of refractory asthma.Frontiers in medicine · 2026Article
- Airway epithelial dysfunction in asthma pathogenesis: epigenetic mechanisms, inflammatory crosstalk, and therapeutic opportunities.Frontiers in allergy · 2026Review
- Harmonized low-dose computed tomographic protocols for quantitative lung imaging using dose modulation and advanced reconstructions.Medical physics · 2025Article
- Impact of clinical factors and season on inflammatory cytokines in biologic-treated and untreated asthma.Respiratory research · 2025Article
- [Acute respiratory distress syndrome-quo vadis : Innovative and individualized treatment approaches].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2025Review
- Pre-biologic disease trajectories are associated with morbidity burden and biologic treatment response in severe asthma.The European respiratory journal · 2025Article
- Integrating hot topics and implementation of treatable traits in asthma.The European respiratory journal · 2024Review
- Asthma Biologics: Lung Function, Steroid-Dependence, and Exacerbations.Immunology and allergy clinics of North America · 2024Review
- Asthma Inception: Epidemiologic Risk Factors and Natural History Across the Life Course.American journal of respiratory and critical care medicine · 2024Review
- Review
- Covariate-adaptive biased coin randomization for master protocols with multiple interventions and biomarker-stratified allocation.Statistics in biopharmaceutical research · 2024Article
- Research Accomplishments in Pulmonary, Critical Care, and Sleep: A Retrospective Review.American journal of respiratory and critical care medicine · 2023Article
- Approaches to Management of Asthma: Guidelines for Stepped Care and Self-Monitoring.Advances in experimental medicine and biology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
57 authors at 20 institutions in 2 countries.
Elliot IsraelDepartment of Medicine, Divisions of Pulmonary & Critical Care Medicine & Allergy & Immunology, Brigham & Women's Hospital, Harvard Medical School, Boston, Mass. Electronic address: eisrael@partners.org.
Loren C DenlingerDepartment of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.
Leonard B BacharierVanderbilt University School of Medicine, Nashville, Tenn.
Lisa M LaVangeDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.
Wendy C MooreWake Forest University School of Medicine, Winston-Salem, NC.
Michael C PetersUniversity of California, San Francisco School of Medicine, San Francisco, Calif.
Steve N GeorasDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Rochester Medical Center, Rochester, NY.
Rosalind J WrightIcahn School of Medicine at Mount Sinai, New York, NY.
David T MaugerPennsylvania State University School of Medicine, Hershey, Pa.
Patricia NoelDivision of Lung Diseases, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Md.
Praveen AkuthotaPulmonary Division, Department of Medicine, University of California-San Diego, La Jolla, Calif.
Julia BachDepartment of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.
Eugene R BleeckerAsthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.
Juan Carlos CardetAllergy and Immunology, University of South Florida, Tampa, Fla.
Tara F CarrAsthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.
Mario CastroUniversity of Kansas School of Medicine, Kansas City, Kan.
Angeles CinelliBrigham and Women's Hospital, Boston, Mass.
Suzy A A ComhairLerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
Ronina A CovarNational Jewish Health, Denver, Colo.
Laura Crotty AlexanderPulmonary Division, Department of Medicine, University of California-San Diego, La Jolla, Calif.
Emily A DiMangoColumbia University Medical Center, New York, NY.
Serpil C ErzurumLerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
John V FahyUniversity of California, San Francisco School of Medicine, San Francisco, Calif.
Merritt L FajtUniversity of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh, Pa.
Benjamin M GastonWells Center for Pediatric Research, Indiana University, Indianapolis, Ind.
Eric A HoffmanDepartment of Radiology, University of Iowa, Iowa City, Iowa.
Fernando HolguinUniversity of Colorado School of Medicine, Aurora, Colo.
Daniel J JacksonDepartment of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.
Sonia JainPulmonary Division, Department of Medicine, University of California-San Diego, La Jolla, Calif.
Nizar N JarjourDepartment of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.
Yuan JiDepartment of Health Studies, University of Chicago, Chicago, Ill.
Nicholas J KenyonDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, University of California Davis School of Medicine, Davis, Calif.
Michael R KosorokDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.
Monica KraftAsthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.
Jerry A KrishnanDivision of Pulmonary, Critical Care, Sleep, and Allergy, Department of Medicine, University of Illinois at Chicago, Chicago, Ill.
Rajesh KumarLurie Children's Hospital, Chicago, Ill.
Andrew H LiuUniversity of Colorado School of Medicine, Aurora, Colo; Children's Hospital Colorado, Aurora, Colo.
Mark C LiuPulmonary and Critical Care Medicine, Department of Medicine, the Johns Hopkins University, Baltimore, Md.
Ngoc P LyUniversity of California, San Francisco School of Medicine, San Francisco, Calif.
M Alison MarquisDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.
Fernando D MartinezAsthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.
James N MoyRush University Medical Center, Chicago, Ill.
Wanda K O'NealCenter for Environmental Medicine, Asthma, and Lung Biology, University of North Carolina, Chapel Hill, NC.
Victor E OrtegaWake Forest University School of Medicine, Winston-Salem, NC.
David B PedenMarsico Lung Institute, UNC CF Research Center, University of North Carolina, Chapel Hill, NC.
Wanda PhipatanakulBoston Children's Hospital and Harvard Medical School, Boston, Mass.
Kristie RossUH Rainbow Babies and Children's Hospitals, Cleveland, Ohio.
Lewis J SmithNorthwestern University, Chicago, Ill.
Stanley J SzeflerUniversity of Colorado School of Medicine, Aurora, Colo; Children's Hospital Colorado, Aurora, Colo.
W Gerald TeagueUniversity of Virginia School of Medicine, Charlottesville, Va.
Abigail F TulchinskyBrigham and Women's Hospital, Boston, Mass.
Pandurangan VijayanandLa Jolla Institute for Immunology, La Jolla, Calif.
Michael E WechslerNational Jewish Health, Denver, Colo; University of Colorado School of Medicine, Aurora, Colo.
Sally E WenzelUniversity of Pittsburgh Asthma Institute, University of Pittsburgh, Pittsburgh, Pa.
Steven R WhiteSection of Pulmonary and Critical Care Medicine, Department of Medicine, University of Chicago, Chicago, Ill.
Amir A ZekiDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, University of California Davis School of Medicine, Davis, Calif.
Anastasia IvanovaDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.
University of Arizona · USUniversity of North Carolina at Chapel Hill · USUniversity of Wisconsin–Madison · USBrigham and Women's Hospital · USUniversity of California San Diego · USUniversity of California, San Francisco · USChildren's Hospital Colorado · USCleveland Clinic Lerner College of Medicine · USNational Jewish Health · USUniversity of California, Davis · USUniversity of Chicago · USUniversity of Pittsburgh · USWake Forest University · USBoston Children's Hospital · USColumbia University Irving Medical Center · USIcahn School of Medicine at Mount Sinai · USIndiana University – Purdue University Indianapolis · USJohns Hopkins University · USLa Jolla Institute for Immunology · USLung Institute · US
Funding
VISUAL INDICES OF NEUROTOXICITYP30ES001247 · UNIVERSITY OF ROCHESTER · 1985 to 2025
$10.5MUniversity of Pittsburgh Clinical and Translational Science InstituteUL1TR001857 · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2025 to 2025
$10.1MUniversity of Wisconsin Institute for Clinical and Translational ResearchUL1TR002373 · UNIVERSITY OF WISCONSIN-MADISON · 2025 to 2025
$8.9MPulmonary Toxicology FacilityP30ES005605 · UNIVERSITY OF IOWA · 1990 to 2025
$8.8MClinical and Translational Science InstituteUL1TR001872 · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2025 to 2025
$8.5MThe Institute for Translational MedicineUL1TR002389 · UNIVERSITY OF CHICAGO · 2025 to 2025
$7.6MTARGETED MODULATION OF VASOPRESSIN IN BRAIN MAGNOCELLULAR NEURONS BY GENE THERAPYP30DK054759 · UNIVERSITY OF IOWA · 1998 to 2025
$7.4MSOUTHWEST ENVIRONMENTAL HEALTH SCIENCES CENTERP30ES006694 · UNIVERSITY OF ARIZONA · 1994 to 2025
$7.3MUNC-CH CENTER FOR ENVIRONMENTAL HEALTH &SUSCEPTIBILITYP30ES010126 · UNIV OF NORTH CAROLINA CHAPEL HILL · 2001 to 2025
$6.9MFrontiers Clinical and Translational Science Institute at the University of KansasUL1TR002366 · UNIVERSITY OF KANSAS MEDICAL CENTER · 2025 to 2025
$3.7MUC Davis Environmental Health Sciences Core CenterP30ES023513 · UNIVERSITY OF CALIFORNIA AT DAVIS · 2025 to 2025
$1.6MRevisiting ReCHARGE: ECHO Follow up on Middle Childhood and AdolescenceUH3OD023365 · UNIVERSITY OF CALIFORNIA AT DAVIS · 2025 to 2025
$0kNCATS NIH HHS U24 TR001608NCATS NIH HHS UL1 TR000427NCATS NIH HHS UL1 TR001422NCATS NIH HHS UL1 TR001442NCATS NIH HHS UL1 TR001857NCATS NIH HHS UL1 TR001872NCATS NIH HHS UL1 TR002366NCATS NIH HHS UL1 TR002373NCATS NIH HHS UL1 TR002389NCATS NIH HHS UL1 TR002489NCATS NIH HHS UL1 TR002541NHLBI NIH HHS K23 HL138303NHLBI NIH HHS R01 HL148715NHLBI NIH HHS R03 HL148486NHLBI NIH HHS U01 HL102225NHLBI NIH HHS U24 HL138998NHLBI NIH HHS UG1 HL139054NHLBI NIH HHS UG1 HL139098NHLBI NIH HHS UG1 HL139106NHLBI NIH HHS UG1 HL139117NHLBI NIH HHS UG1 HL139118NHLBI NIH HHS UG1 HL139119NHLBI NIH HHS UG1 HL139123NHLBI NIH HHS UG1 HL139124NHLBI NIH HHS UG1 HL139125NHLBI NIH HHS UG1 HL139126NIAID NIH HHS K23 AI125785NIDDK NIH HHS P30 DK054759NIEHS NIH HHS P30 ES001247NIEHS NIH HHS P30 ES005605NIEHS NIH HHS P30 ES006694NIEHS NIH HHS P30 ES010126NIEHS NIH HHS P30 ES023513NIH HHS UH3 OD023365
Abstract
Severe asthma accounts for almost half the cost associated with asthma. Severe asthma is driven by heterogeneous molecular mechanisms. Conventional clinical trial design often lacks the power and efficiency to target subgroups with specific pathobiological mechanisms. Furthermore, the validation and approval of new asthma therapies is a lengthy process. A large proportion of that time is taken by clinical trials to validate asthma interventions. The National Institutes of Health Precision Medicine in Severe and/or Exacerbation Prone Asthma (PrecISE) program was established with the goal of designing and executing a trial that uses adaptive design techniques to rapidly evaluate novel interventions in biomarker-defined subgroups of severe asthma, while seeking to refine these biomarker subgroups, and to identify early markers of response to therapy. The novel trial design is an adaptive platform trial conducted under a single master protocol that incorporates precision medicine components. Furthermore, it includes innovative applications of futility analysis, cross-over design with use of shared placebo groups, and early futility analysis to permit more rapid identification of effective interventions. The development and rationale behind the study design are described. The interventions chosen for the initial investigation and the criteria used to identify these interventions are enumerated. The biomarker-based adaptive design and analytic scheme are detailed as well as special considerations involved in the final trial design.
Indexed as
AsthmaBiomarkersPrecision MedicineRandomized Controlled Trials as TopicAdaptive Clinical Trials as TopicHumansResearch DesignBiomarkersadaptive designbiomarkersclinical trialmaster protocolplatform trialprecision medicineSevere asthmatherapy
Identifiers
What Socratic holds
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Read underepoch 390
Registered trials
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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 Socratic graph.