RecruitingPhase 3NCT04699604

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

Sponsor

Bridgette Jones

Enrollment

300 participants

Start Date

Apr 28, 2021

Study Type

INTERVENTIONAL

Conditions

Allergic Asthma

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.

Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a specific biological marker related to histamine can help doctors choose the best treatment plan for children with uncontrolled asthma. The goal is to personalize asthma care based on each child's biology. **You may be eligible if...** - You are between 6 and 17 years old - You have been diagnosed with asthma by a doctor - Your asthma is not well-controlled (based on a standardized questionnaire) - You have evidence of allergies (based on skin or blood tests) - You are currently on guideline-based asthma therapy **You may NOT be eligible if...** - You are under 6 or 18 and older - Your asthma is well-controlled - You have no evidence of allergic sensitization - You have other serious medical conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLevocetirizine 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.

DRUGPlacebo

Placebo