Wednesday, July 2, 2025 7/2/2025

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

Award Number: R01HD100545
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/05/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2025

Group Awards By:

View Award Description

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma - 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 therapeutic efficacy and outcomes in these children.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $283,465 )
2024	2024	CHILDRENS MERCY HOSPITAL	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	5	6/7/2024	NON-COMPETING CONTINUATION	$283,465
														Subtotal = $283,465

Issue Date FY: 2023 ( Subtotal = $632,347 )
2023	2023	CHILDREN'S MERCY HOSPITAL, THE	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	3	12/30/2022	SUPPLEMENT FOR EXPANSION	$71,316
2023	2023	CHILDRENS MERCY HOSPITAL	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	001	4	5/23/2023	NON-COMPETING CONTINUATION	$511,735
2023	2023	CHILDRENS MERCY HOSPITAL	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	003	4	7/17/2023	SUPPLEMENT FOR EXPANSION	$49,296
2023	2023	CHILDRENS MERCY HOSPITAL	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	002	3	7/17/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $632,347

Issue Date FY: 2022 ( Subtotal = $508,269 )
2022	2022	CHILDREN'S MERCY HOSPITAL, THE	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	3	5/19/2022	NON-COMPETING CONTINUATION	$508,269
														Subtotal = $508,269

Issue Date FY: 2021 ( Subtotal = $520,693 )
2021	2021	CHILDREN'S MERCY HOSPITAL, THE	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	001	2	5/18/2021	NON-COMPETING CONTINUATION	$520,693
2021	2020	CHILDREN'S MERCY HOSPITAL, THE	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	1	10/15/2020	NEW	$0
														Subtotal = $520,693

Issue Date FY: 2020 ( Subtotal = $549,395 )
2020	2020	CHILDREN'S MERCY HOSPITAL, THE	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	1	6/2/2020	NEW	$549,395
														Subtotal = $549,395

Grand Total All Awards = $2,494,169

Top

All Categories

About

Search

Reports

Data Submission

Award Information

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

Award Number: R01HD100545

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/05/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2025

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer