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

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Bridgette Jones
Study ID
NCT04699604
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Levocetirizine Dihydrochloride — DRUG
    At the end of the HILD assessment participants will be randomized to Levocetirizine Dihydrochloride or placebo. Children will be randomized by an investigational pharmacist to add-on either 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) or placebo to their current asthma regimen.
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Apr 28, 2021
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Therapeutic response to antihistamine [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Mercy HospitalKansas CityMissouri64108
Darlene Brenson-Hughes
[email protected]
816.731.7386
Bridgette Jones, MD
[email protected]
816-731-7072
Bridgette Jones, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Kansas City, MO

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Children's Mercy Hospital· Kansas City, MO

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