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

Launched by BRIDGETTE JONES · Jan 5, 2021

Keywords

ClinConnect Summary

The HAS3 clinical trial is studying how a specific treatment called Levocetirizine (LTZ) can help improve asthma control in children with allergic asthma. This trial focuses on African American/Black and Caucasian/White children aged 6 to 17 who have been diagnosed with uncontrolled asthma. To qualify for the study, children must show evidence of allergies, currently be receiving asthma treatment, and be willing to participate.

Participants in the trial will be randomly assigned to receive either the active treatment (Levocetirizine) or a placebo (a harmless pill with no active ingredients) for a set period. After this, they will switch to the other treatment. Throughout the study, children will undergo tests to evaluate how well their asthma is controlled. It's important to know that children who are pregnant, have certain chronic health conditions, or have experienced severe reactions to Levocetirizine will not be eligible. This study aims to find out if using a histamine biomarker can help guide better asthma treatment for kids.

Gender

ALL

Eligibility criteria

• 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 2nd degree relatives (grandparents) as African American) or Caucasian/white (self-report of 1st and 2nd degree relatives as Caucasian)
• Exclusion Criteria:
• • 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
• • 8. Active eczema at the site where histamine laser doppler probe will be place(forearm) on the day of histamine laser doppler iontophoresis
• • 9. Age 18 years or older at the time of enrollment.
• • 10. Those whom are pregnant, prisoners, and/or wards of the state.
• • 11. Currently on or has been on Tricyclic Antidepresants in past 30 days