Status:
RECRUITING
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
Lead Sponsor:
Bridgette Jones
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Allergic Asthma
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04699604
Start Date
April 28 2021
End Date
May 1 2026
Last Update
April 8 2025
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108