A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

Led by Bridgette Jones · Updated on 2026-07-01

Participants Needed

Research Sites

1 weeks

Total Duration

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

Brief Title

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

Who Can Participate

Age: 6Years - 17Years

All Genders

Eligibility Criteria

Inclusion Criteria:

A diagnosis of asthma based on physician diagnosis
A diagnosis of uncontrolled asthma based on Asthma Control Test (ACT) score within the last 3 months or at screening
Evidence of allergic sensitization based on allergy skin test or allergy blood test results
Individuals who are currently being treated with asthma guideline-based therapy
Males and females 6 through 17 years of age at time of enrollment
Willing to provide written permission/assent to participate
Children who self-identify as African American/black (identify both 1st degree (parents) and 2nd degree relatives (grandparents) as African American) or Caucasian/white (self-report of 1st and 2nd degree relatives as Caucasian)

Exclusion Criteria:

For females, positive pregnancy test (by urinary hCG) or lactation at the time of the study
Any other chronic disease states such as history of premature lung disease, bronchiectasis, cystic fibrosis, or any chronic lung disease other than asthma.
Chronic abnormal conditions of the liver or kidney, immunologic/hematologic, or neoplastic disease as determined by the PI (the following questions will be asked at initial screening to identify children with potential abnormal kidney function:

Have you ever been diagnosed with chronic kidney disease?; Have you ever had to be on dialysis or take medications for chronic kidney disease?)
Inability or unwillingness to have blood drawn as described in the protocol schedule of events and consent, or inability or unwillingness to cooperate with study procedures.
Clinically significant abnormal safety laboratory values as determined by study physician
Previous history of adverse drug reaction to Levocetirizine (LTZ)
Unwillingness or inability to washout of medications that affect histamine response
Active eczema at the site where histamine laser doppler probe will be place(forearm) on the day of histamine laser doppler iontophoresis
Age 18 years or older at the time of enrollment.
Those whom are pregnant, prisoners, and/or wards of the state.
Currently on or has been on Tricyclic Antidepresants in past 30 days

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A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria