# A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

> **NIH NIH R01** · CHILDREN'S MERCY HOSP (KANSAS CITY, MO) · 2020 · $549,395

## Abstract

Abstract
There is a critical need for validated objective biomarkers that predict therapeutic response for asthma
therapies in children. Children who require daily asthma treatment with a controller medication such as an
inhaled steroid are defined to have persistent asthma. Approximately 60% of children with asthma in the United
States have persistent disease. Variability in treatment response to standard guideline supported medications
(e.g. inhaled steroids, leukotriene modifiers, mono-clonal antibodies) exist among children with persistent
asthma. Clinical markers such as IgE level, exhaled nitric oxide level, eosinophil and neutrophil counts have not
been validated to predict treatment response to asthma medications in children. It is not possible to optimize
currently available treatments for asthma in achieving therapeutic efficacy and limiting exposure to adverse
effects from non-efficacious medications without robust non-invasive biomarkers that can drive therapeutic
decision making. The long-term goal is to advances and improve therapeutic intervention for pediatric patients
with asthma. The objective in this particular application is to establish the utility of Histamine Iontophoresis with
Laser Doppler monitoring (HILD) as biomarker for accurate prediction of therapeutic response to low cost and
low side-effect antihistamine treatment in children with allergic asthma. The central hypothesis is that “HILD is
predictive of treatment response to an antihistamine in children with asthma”. This hypothesis has been
formulated by the applicant's strong preliminary data and supporting literature. The rationale for the proposed
research is that HILD is able to identify distinct histamine pharmacodynamic response types that predict
treatment response to antihistamine medications in asthma. Guided by strong preliminary data, this hypothesis
will be tested by two specific aims: 1) to determine HILD prediction of therapeutic response to an antihistamine
among children with allergic asthma; 2) to develop a robust predictive model of therapeutic response to an
antihistamine among children with allergic asthma. The first aim will compare change in Asthma Control Test
(ACT®) scores by histamine response type in a six week, 2x2 cross-over, add-on trial of Levocetirizine (LTZ)
among children with uncontrolled allergic asthma. The second aim will determine the best predictive model
(incorporating HILD and clinical variables) for change in ACT® scores after LTZ treatment among children with
allergic asthma. The proposed research is significant because it has the potential to alter the current treatment
paradigms for children with asthma where response to treatment is predicted a priori; and is innovative in testing
and validating a first biomarker accurately predicting response to an asthma treatment in children. The
knowledge gained will make available the first validated biomarker to predict treatment response in children with
asthma and will improve th...

## Key facts

- **NIH application ID:** 9861549
- **Project number:** 1R01HD100545-01
- **Recipient organization:** CHILDREN'S MERCY HOSP (KANSAS CITY, MO)
- **Principal Investigator:** BRIDGETTE L. JONES
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $549,395
- **Award type:** 1
- **Project period:** 2020-06-05 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9861549

## Citation

> US National Institutes of Health, RePORTER application 9861549, A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (1R01HD100545-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9861549. Licensed CC0.

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