A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
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 us
| Condition(s) | Allergic Asthma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 | 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 u |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Lead sponsor | Bridgette Jones |
| Locations | Kansas City, Missouri, United States |
| Start date | 2021-04-28 |
| NCT ID | NCT04699604 |
| Official listing | https://clinicaltrials.gov/study/NCT04699604 |