RecruitingAllergic Asthma
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
Eligible age
6–17 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Bridgette Jones
You may qualify if…
- ✓ 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 2nd degree relatives (grandparents) as African American) or Caucasian/white (self-report of 1st and 2nd degree relatives as Caucasian)
You may not qualify if…
- ✕ 1. For females, positive pregnancy test (by urinary hCG) or lactation at the time of the study
- ✕ 2. Any other chronic disease states such as history of premature lung disease, bronchiectasis, cystic fibrosis, or any chronic lung disease other than asthma.
- ✕ 3. 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?)
- ✕ 4. 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.
- ✕ 5. Clinically significant abnormal safety laboratory values as determined by study physician
- ✕ 6. Previous history of adverse drug reaction to Levocetirizine (LTZ)
- ✕ 7. Unwillingness or inability to washout of medications that affect histamine response
Where it's recruiting
Missouri
Kansas City
Source: ClinicalTrials.gov · NCT04699604 · last updated 2026-04-22