Controlling and preventing asthma progression and severity in kids with omalizumab extension (park-EXT)

Active Cooperative Agreement Awarded Last action

Award ID
U01AI179563
Recipient
Awarding agency
Obligated
$9,000,000

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date 48% complete
Place of performance
Boston, MA 02115, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Asthma is the #1 chronic disease in childhood: prevention is an unmet need and pressing priority. We are conducting the first randomized, double-blind, placebo controlled trial in 200 high risk children 2-3 years of age to determine whether 2 years of treatment with omalizumab (anti-IGE) will prevent asthma and/or diminish asthma severity 2 years after treatment is stopped. Our hypothesis revolves around the role that IGE plays in the development of persistent asthma by catalyzing allergic type 2 driven recurrent wheezing and augmenting virally-induced exacerbations in susceptible young children. Recent studies have demonstrated the feasibility and power of using new and novel systems-scale network analysis of transcriptional pathways and epigenetic signatures to assess airway responses in readily obtained nasal samples. We hypothesize that patients who respond to anti-IGE may have upregulated expression of genes related to antiviral responses, epithelial cell structure and barrier integrity. This project will allow US to complete the trial and use state of the art epigenomic and transcriptomic techniques with integrative approaches to explore this hypothesis and examine the role of specific alterations in treg cells and antigen-specific t cells in transducing clinical responses seen in the trial. Our first aim is to complete the trial to assess whether interfering with environmental allergen IGE-mediated immunological responses can prevent or moderate a progression to asthma in susceptible children. Our second aim is to examine the relationship between anti-viral and epithelial integrity pathways and the response to anti-IGE through DNA methylation and transcriptomic signatures and associated effects on type 2 inflammation, wheezing episodes, asthma, and asthma severity. We will extend our findings to include single- cell transcriptional profiling in a subset to more fully inform the cellular sources of bulk transcriptome responses and provide important molecular details about individual cell heterogeneity and rare cell populations that relate to clinical responsiveness and clinical outcomes. We will integrate multi-omic and clinical data and perform analyses to define the combined transcriptomic and epigenetic changes underlying response to anti-IGE treatment and the persistence or resolution of benefit (including asthma outcome) following cessation of therapy. These signatures will provide comprehensive mechanistic insights on clinical treatment effects of responders VS. Non-responders, and specific DNA methylation and gene expression molecular pathways that impact study outcomes and elucidate the disease modifying effects of anti-IGE. Differences in these profiles could provide potential biomarkers predictive of clinical and immunologic response to anti-IGE. This study is potentially paradigm shifting - regardless of the outcomes of the trial, we will gain considerable knowledge on the pathophysiology of the disease and the impact of interfering with IGE mediated processes at a critical time period where the immunologic and clinical phenotype is evolving but not yet fully established.

Transactions

Action Obligated Date
Amendment $2,250,000
Amendment $0
Amendment $0
Amendment $2,250,000
Amendment $2,250,000
Original award $2,250,000

Subawards

Subrecipient Amount Awarded
Pennsylvania State University The Penn State College of Medicine’s Department of Public Health Sciences will provide data management and analysis services for the multicenter study entitled,… $531,361
University Of Wisconsin System We will do nasal viral studies on nasal samples collected at surveillance and as needed during viral wheeze which is estimated at 600 nasal samples throughout… $38,564
The University Of Chicago Dr. Ober and her staff will extract DNA from blood cells for genotyping (n=300) and from nasal swabs (n=100). They will generate genotype data (n=300) and DNA… $321,601
The Regents Of The University Of Colorado We will serve as a subcontractor and Clinical Center (CC) for the Controlling and Preventing Asthma progression and Severity in Kids with Omalizumab… $40,557
The University Of Iowa Bioaerosol Exposures in the PARK Study includes the following tasks: 1. Participate in teleconferences and Email exchanges as needed to ensure proper sample… $13,684
Brigham & Womens Hospital Inc. Dr. Israel will participate in executive committee calls and work with analysis and publication of papers from this project. He will also work with the team… $49,920
University Of Washington Dr. Altman has his primary appointment at University of Washington (UW) and secondary appointment at Benaroya Research Institute (BRI). As a Co-Investigator… $22,532
Benaroya Research Institute At Virginia Mason Dr. Altman has his primary appointment at University of Washington (UW) and secondary appointment at Benaroya Research Institute at Virginia Mason (BRI). As… $53,030
University Of Pittsburgh - Of The Commonwealth System Of Higher Education Professor Chris McKennan will lead efforts to develop statistical models and methods to develop statistical models and methods to analyze the DNA methylation… $16,972
The Pennsylvania State University "The Penn State College of Medicine’s Department of Public Health Sciences will provide data management and analysis services for the multicenter study… $416,109
The Washington University Site SOW: We will serve as a subcontractor and Clinical Center (CC) for the Controlling and Preventing Asthma progression and Severity in Kids with Omalizumab… $80,208
Show all 11

Quick answers

Who received award U01AI179563?

U01AI179563 was awarded to The Children's Hospital Corporation by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on July 8, 2024.

How much is award U01AI179563 worth?

$9,000,000 has been obligated on U01AI179563.

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