Using a biomarker to guide asthma treatment in children
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma
This study is testing if an antihistamine called Levocetirizine can help children aged 6-17 with uncontrolled allergic asthma feel better, while also looking at how different racial groups respond to the treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT04699604 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of Levocetirizine, an antihistamine, in improving asthma control among children aged 6-17 with uncontrolled allergic asthma. It will compare responses between African American/Black and Caucasian/White children based on their histamine response type, categorized as hyper or hypo-responsive. The study employs a randomized, double-blind, placebo-controlled, crossover design, involving 300 participants over approximately 17 weeks. The goal is to develop a predictive model for therapeutic response to antihistamines in pediatric asthma management.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-17 with a diagnosis of uncontrolled allergic asthma who identify as African American/Black or Caucasian/White.
Not a fit: Patients with other chronic lung diseases or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective asthma treatments for children based on their specific histamine response.
How similar studies have performed: While this approach is novel in its specific application to pediatric asthma, similar studies have shown promise in using biomarkers to guide treatment in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Missouri
- Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Darlene Brenson-Hughes, CCRC
- Email: dbrensonhughes@cmh.edu
- Phone: 816-731-8376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.