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

Completed · Phase 3 · Has a placebo group

Conditions studied: Allergic Asthma

In brief

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.

Key facts

Study ID

NCT04699604

Run by

Bridgette Jones

People needed

55

Starts

2021-04-28

Expected to finish

2026-04-26

Last updated by the study team

2026-07-01

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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