# San Diego Team Asthma Management using Phenotypes (STAMP)

> **NIH NIH UG1** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2021 · $396,501

## Abstract

Project Summary/Abstract
 There has been increasing recognition over the last several years of the heterogeneity in the pathobiologic
underpinnings of asthma and the critical importance of phenotyping and endotyping in dictating response to
therapy. For example, it was only after selecting patients with sputum (and later blood) eosinophilia and using
exacerbation rate as the primary outcome, was the utility of mepolizumab in asthma uncovered in a clinical trial
setting. With multiple immune-modulating biologic agents already available and with more to come in the very
near future, our understanding how to best deploy these agents in a precise manner to patients with severe
and/or exacerbation-prone asthma (those who would be most likely to be prescribed biologic agents) must be
refined. The PrecISE Network will use sequential, adaptive clinical trial designs, which represents a novel
approach in asthma clinical research, to answer these questions, while also presenting an opportunity for
significant progress in phenotyping and endotyping as applied to clinical management of patients with severe
asthma. In this application, we propose the following Specific Aims: 1) Establishment of the San Diego Team
Asthma Management Program (STAMP) as a Clinical Center in the NHLBI PrecISE Network: We have put
together a team that leverages the substantial resources of UCSD and the San Diego region to create a
PreCISE Clinical Center that will optimally recruit subjects and perform PrecISE Network protocols as they are
developed and implemented. 2) Proposal of a PrecISE Netowrk Clinical Trial Using a sequential, adaptive,
phase IIb/proof of concept design: In accordance with the goals of the PrecISE Network, our proposed trial
design will be center on the use of precision interventions based on stratification of severe asthma subjects by
phenotype/endotype. Using already established biomarkers, including blood/sputum eosinophilia, serum
periostin, serum IgE, and exhaled NO, we propose to stratify subjects into Th2-high (“Th2H”), non-Th2-high
(“NTh2H”), and MIXED endotypes to dictate experimental interventions. Th2H and MIXED subjects would be
randomized to placebo, Allakos (Anti-Siglec-8 monoclonal antibody), or dupilumab (anti-IL4/IL13 receptor).
Concurrently, NTh2H subjects would be randomized into placebo, etanercept (TNF inhibitor), or dupilumab.
During the trial, some of these interventions may be shown to have a lack of sufficient activity and these will be
withdrawn after interim analysis and replaced by new agents or by new biomarker-defined groups. Successful
treatments at the interim analysis stage will proceed to the next stage. 3) Identification of novel biomarkers to
stratify responders to targeted treatments: Our group has the scientific expertise to perform and analyze novel
biomarker studies associated with PrecISE protocols. We propose to leverage these micro-scaled genomic
and immunology tools to identify novel biomarkers for treatment respons...

## Key facts

- **NIH application ID:** 10220116
- **Project number:** 5UG1HL139117-05
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Praveen Akuthota
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $396,501
- **Award type:** 5
- **Project period:** 2017-09-23 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10220116

## Citation

> US National Institutes of Health, RePORTER application 10220116, San Diego Team Asthma Management using Phenotypes (STAMP) (5UG1HL139117-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10220116. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*