A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3) (NCT04699604) | Clinical Trial Compass
RecruitingPhase 3
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
United States300 participantsStarted 2021-04-28
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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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:
✕. 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.