Actively Recruiting
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
Led by Bridgette Jones · Updated on 2026-04-22
300
Participants Needed
1
Research Sites
317 weeks
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
This is a randomized, double-blind, placebo-controlled, crossover study comparing asthma control post treatment in African American/Black and Caucasian/White children in both hyper and hypo responsive HILD (Histamine Lontophoresis with Laser Doppler monitoring) phenotypes with uncontrolled persistent allergic asthma using Levocetirizine (LTZ) vs placebo.
CONDITIONS
Official 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 receiving asthma treatment based on guidelines
- Males and females aged 6 through 17 years at enrollment
- Willing to provide written permission or assent to participate
- Self-identify as African American/Black or Caucasian/White with specified family ancestry
You will not qualify if you...
- Positive pregnancy test or lactation for females at study time
- Other chronic lung diseases besides asthma (e.g., premature lung disease, bronchiectasis, cystic fibrosis)
- Chronic liver, kidney, immune, blood, or cancer diseases as determined by investigator
- Inability or refusal to have blood drawn or cooperate with study procedures
- Clinically significant abnormal lab safety values
- Previous adverse reaction to Levocetirizine
- Unwillingness or inability to stop medications affecting histamine response
- Active eczema at site of histamine laser doppler probe on study day
- Age 18 years or older at enrollment
- Pregnant, prisoners, or wards of the state
- Current or recent (past 30 days) use of tricyclic antidepressants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Susan Flack, RN CCRC
CONTACT
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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