A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

Who is this study for? Children 6 years to 17 years with asthma
What treatments are being studied? Levocetirizine Dihydrochloride
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• 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)

Locations
United States
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
Contact Information
Primary
Darlene Brenson-Hughes, CCRC
dbrensonhughes@cmh.edu
816-731-8376
Backup
Susan Flack, RN CCRC
sflack@cmh.edu
816-960-8904
Time Frame
Start Date: 2021-04-28
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 300
Treatments
Active_comparator: Levocetirizine (LTZ)
Participants will take Levocetirizine dihydrochloride/ Xyzal® (UCB, Inc.) immediate release oral solution 2.5mg/5ml (2.5mg in children 6-11 years of age; 5mg in children \>11 years per recommended doses) in addition to their current asthma regimen.
Placebo_comparator: Placebo
Participants will take a placebo solution previously developed by the Children's Mercy Investigational Pharmacy to match the color, flavor, and consistency of the active drug in addition to their current asthma regimen.
Related Therapeutic Areas
Sponsors
Leads: Bridgette Jones
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov