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

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bridgette Jones; Children's Mercy Hospital Kansas City
• Treatments: Levocetirizine

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 (identify both 1st degree (parents) and 2nd degree relatives (grandparents) as African American) or Caucasian (self-report of 1st and 2nd degree relatives as Caucasian)

8. Subject demonstrates >12 % reversibility of FEV1 after 4 puffs of albuterol at screening or historically

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. Children being currently treated with immunomodulatory asthma treatments (e.g. Omalizumab)

4. Chronic abnormal conditions of the liver or kidney, immunologic/hematologic, or neoplastic disease as determined by the PI

5. Inability or unwillingness to have blood drawn as described in the protocol schedule of events and consent

6. Clinically significant abnormal safety laboratory values as determined by study physician

7. Previous history of adverse drug reaction to Levocetirizine (LTZ)

8. Unwillingness or inability to washout of medications that affect histamine response

9. Subject is considered by PI to be unsuitable for participation in the study for any reason

10. Active eczema at the site where histamine laser doppler probe will be placed (forearm) on the day of histamine laser doppler iontophoresis

11. Age 18 years or older at the time of enrollment.

12. Those whom are pregnant, prisoners, and/or wards of the state.