# The Great Lakes PrecISE Partnership

> **NIH NIH UG1** · UNIVERSITY OF WISCONSIN-MADISON · 2021 · $384,084

## Abstract

Abstract:
The lack of data to inform treatment guidelines in patients with severe asthma remains a major unmet need.
Our vision is to develop a personalized medicine approach for the treatment of severe asthma, directed at its
pathogenesis and ultimately translatable to the community health care setting for implementation. Because
traditional clinical trial designs are inefficient for diseases with multiple phenotypes, our central hypothesis is
that the application of an adaptive trial design will identify subtypes of severe asthma that will be most
responsive to precise interventions. The scientific rationale for this proposal includes recent data showing that
elevated blood eosinophils, maximum FEV1 reversal, and plasma IL-6 concentrations are risk factors for
frequent exacerbations which are a major component of severe asthma. Each of these phenotypes has precise
interventions that are FDA approved for asthma or other diseases, namely anti-IL-5 antibodies, long acting
muscarinic antagonists, and anti-IL6 receptor antibodies. We propose the following Specific Aims to test this
hypothesis: 1) To determine the impact of phenotype-directed interventions on the frequency of asthma
exacerbations using a sequential Bayesian adaptive clinical trial design, stratified by blood eosinophils,
maximum FEV1 reversal, and plasma IL-6 concentrations; and 2) To validate the predictive value of monitoring
biomarkers assessed at baseline and after three months of treatment. These biomarkers include sputum
eosinophils, heart rate variability, C-reactive protein levels, air trapping and other imaging metrics assessed by
low dose chest CT scan, and measures of airway oxidant stress. Our team of multi-disciplinary investigators
and translational science clinicians in the Great Lakes PrecISE Partnership has access to a diverse population
of patients with severe asthma from Wisconsin and Northern Illinois which will enable us to be a very active
partner in this collaborative network. We expect to rapidly identify patient subsets that benefit from therapies
not currently considered as part of the asthma pharmacopoeia. The efficient assessment of these biomarkers
and precise treatments would not be possible without this departure from the typical therapeutic development
process.

## Key facts

- **NIH application ID:** 10219822
- **Project number:** 5UG1HL139118-05
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** Loren C Denlinger
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $384,084
- **Award type:** 5
- **Project period:** 2017-09-23 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10219822

## Citation

> US National Institutes of Health, RePORTER application 10219822, The Great Lakes PrecISE Partnership (5UG1HL139118-05). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10219822. Licensed CC0.

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