Actively Recruiting
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma
Led by Bridgette Jones · Updated on 2026-04-22
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Bridgette Jones
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying allergic asthma in children aged 6 to 17 years who identify as African American/Black or Caucasian/White. This randomized, double-blind, placebo-controlled crossover trial evaluates whether the antihistamine Levocetirizine (LTZ) improves asthma control in children with different histamine response types measured by Histamine Lontophoresis with Laser Doppler monitoring (HILD). The study aims to develop a biomarker that predicts therapeutic response and improve treatment decisions in pediatric asthma. Participants will be randomly assigned to receive either Levocetirizine dihydrochloride oral solution (2.5mg for children 6-11 years and 5mg for children over 11) or a placebo, both added to their current asthma therapy. The study includes screening, treatment periods, and assessments at baseline, 6 weeks after starting treatment, and after crossover to the alternate treatment. Each arm lasts approximately 6 weeks, with a total participation time of around 17 weeks. Children will undergo asthma control assessments using the Asthma Control Test (ACT) or Child-Asthma Control Test (C-ACT) depending on age. Other measures include asthma impairment, risk, and quality of life evaluations. Blood draws and HILD testing will be performed to monitor histamine response. The primary outcome is the change in asthma control after 6 weeks of treatment. Safety and adherence will be monitored throughout the study.
CONDITIONS
Brief Title
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Physician diagnosis of asthma
- Uncontrolled asthma based on Asthma Control Test (ACT) score within the last 3 months or at screening
- Evidence of allergic sensitization by allergy skin or blood test
- Currently treated with asthma guideline-based therapy
- Males and females aged 6 through 17 years at enrollment
- Willing to provide written permission/assent
- Self-identify as African American/Black or Caucasian/White with reported family ancestry
You will not qualify if you...
- Positive pregnancy test or lactation for females at study time
- Other chronic lung diseases (premature lung disease, bronchiectasis, cystic fibrosis) except asthma
- Chronic liver, kidney, immunologic, hematologic, or neoplastic diseases
- Inability or unwillingness to have blood drawn or cooperate with study procedures
- Clinically significant abnormal safety lab values
- Previous adverse reaction to Levocetirizine
- Unwillingness or inability to stop medications affecting histamine response
- Active eczema at forearm site for histamine laser doppler test
- Age 18 years or older at enrollment
- Pregnancy, prisoner status, or ward of the state
- Current or recent (past 30 days) use of tricyclic antidepressants
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive either Levocetirizine or placebo in addition to their current asthma regimen to evaluate therapeutic response.
3 visits (baseline, 3 weeks, and 6 weeks during treatment)
Duration - 6 weeks
Participants receive the alternate study drug (Levocetirizine or placebo) in addition to their current asthma regimen following a crossover design.
3 visits (baseline, 3 weeks, and 6 weeks during treatment)
Trial Site Locations
Total: 1 location
1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
Research Team
D
Darlene Brenson-Hughes, CCRC
S
Susan Flack, RN CCRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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