# PrecISE Network:  ADAPT (Advancing Severe Asthma Precision Therapy)

> **NIH NIH UG1** · UNIVERSITY OF ARIZONA · 2021 · $425,299

## Abstract

Severe asthma is a complex heterogeneous disease with significant health care utilization, poor quality of life
and increased mortality. Our understanding of the disease pathobiology has significantly advanced,
particularly through the NHLBI Severe Asthma Research Program (SARP). Through multivariate cluster
analyses using objective physiologic and biologic parameters, unbiased phenotypic analyses divides the
spectrum of asthma into subpopulations with specific disease characteristics that strongly suggest variability in
therapeutic responses to corticosteroid and additional controller therapies. This heterogeneity is particularly
apparent among asthmatic patients with more severe disease. This approach, based on understanding
disease pathobiology, has greater personalized therapeutic implications than an approach which just broadly
classifies severe asthma as asthma that is not adequately controlled using corticosteroids and additional
controllers. This proposal represents an extension of the understanding gained in SARP, where we will define
therapeutic responses across a spectrum of severe asthma to further define phenotypes/endotypes using
known biomarkers while developing and testing novel molecular and genomic biomarkers. While the
understanding of severe asthma phenotype/endotype pathobiology has advanced, the response to therapies
which target specific inflammatory pathways in asthma is not completely understood. Furthermore, we are not
able to definitively predict response to treatments based upon a priori clinical characteristics and expression of
known biomarkers. To advance precision medicine approaches in severe asthma, it is crucial to understand
the phenotypes and endotypes including cellular, protein and genomic biomarkers that predict asthma
pharmacologic responsiveness to specific asthma interventions. We hypothesize that adaptive sequential
clinical trials are an important fundamental approach to address asthma heterogeneity and to make
major advances in the treatment of severe asthma. To test this hypothesis, we will perform clinical and
molecular phenotyping in participants with severe and/or exacerbation prone asthma to include
responsiveness to corticosteroids to identify specific phenotypes/endotypes for participation in a network wide
PrecISE trial. (Aim 1). In Aim 2, we will collaborate with all other clinical sites to perform innovative, sequential
adaptive clinical trials including novel interventions based on predictive biomarkers. In Aim 3, we will refine
current biomarkers and develop new predictive and dynamic biomarkers of response before and after
treatment with targeted therapies to increase their predictive abilities and introduce new biomarkers to the
clinical arena. This proposal will allow patients with severe asthma access to novel therapies and improve our
ability to predict therapeutic responses using clinical and molecular biomarkers in this heterogeneous disease.

## Key facts

- **NIH application ID:** 10220117
- **Project number:** 5UG1HL139054-05
- **Recipient organization:** UNIVERSITY OF ARIZONA
- **Principal Investigator:** EUGENE ROLAND BLEECKER
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $425,299
- **Award type:** 5
- **Project period:** 2017-09-23 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10220117

## Citation

> US National Institutes of Health, RePORTER application 10220117, PrecISE Network:  ADAPT (Advancing Severe Asthma Precision Therapy) (5UG1HL139054-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10220117. Licensed CC0.

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