A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma
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.
Description
The investigator hypothesizes that children with a hyper-responsive HILD (Histamine Lontophoresis with Laser Doppler monitoring) response type are more likely to have improved asthma control after the addition of the antihistamine LTZ (Levocetirizine) to standard asthma regimen in comparison to children with hypo-responsive HILD type. This study will provide a model for a functional biomarker to inform decision making for therapeutics in children. This work is novel in testing and validating a biomarker accurately and predicting response to asthma treatment in children. This work is significan…
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. A diagnosis of asthma based on physician diagnosis 2. A diagnosis of uncontrolled asthma based on Asthma Control Test (ACT) score within the last 3 months or at screening 3. Evidence of allergic sensitization based on allergy skin test or allergy blood test results 4. Individuals who are currently being treated with asthma guideline-based therapy 5. Males and females 6 through 17 years of age at time of enrollment 6. Willing to provide written permission/assent to participate 7. Children who self-identify as African American/black (identify both 1st degree (parents) and…
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
Location
- Children's Mercy HospitalKansas City, Missouri