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A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
Sponsor: Bridgette Jones
Summary
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.
Official title: A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2021-04-28
Completion Date
2026-09-30
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Levocetirizine Dihydrochloride
At the end of the HILD assessment participants will be randomized to Levocetirizine Dihydrochloride or placebo. Children will be randomized by an investigational pharmacist to add-on either Levocetirizine dihydrochloride/ Xyzal® (UCB, Inc.) immediate release oral solution 2.5mg/5ml (2.5mg in children 6-11 years of age; 5mg in children \>11 years per recommended doses) or placebo to their current asthma regimen.
Placebo
Placebo
Locations (1)
Children's Mercy Hospital
Kansas City, Missouri, United States