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

NCT04699604 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY000012625R01HD100545-05
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (1)

• Therapeutic response to antihistamine

  Determined by change in asthma as determined by the Asthma Control Test (ACT®) or Child-Asthma Control Test (C-ACT®) based on the child's age. Asthma control will be assessed at baseline prior to randomization and then at 6 weeks during both arms (placebo and Levocetrizine) of the study.

  6 weeks

Secondary Outcomes (2)

• Asthma exacerbation rates

  6 weeks

• Asthma related quality of life

  6 weeks

Study Arms (2)

Levocetirizine (LTZ)

ACTIVE COMPARATOR

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.

Drug: Levocetirizine Dihydrochloride

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

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.

Also known as: Xyzal

Levocetirizine (LTZ)

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• For females, positive pregnancy test (by urinary hCG) or lactation at the time of the study
• Any other chronic disease states such as history of premature lung disease, bronchiectasis, cystic fibrosis, or any chronic lung disease other than asthma.
• 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?)
• 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.
• Clinically significant abnormal safety laboratory values as determined by study physician
• Previous history of adverse drug reaction to Levocetirizine (LTZ)
• Unwillingness or inability to washout of medications that affect histamine response
• Active eczema at the site where histamine laser doppler probe will be place(forearm) on the day of histamine laser doppler iontophoresis
• Age 18 years or older at the time of enrollment.
• Those whom are pregnant, prisoners, and/or wards of the state.
• Currently on or has been on Tricyclic Antidepresants in past 30 days

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Bridgette Jones: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Interventions

levocetirizine

Central Study Contacts

Darlene Brenson-Hughes, CCRC

CONTACT

816-731-8376; dbrensonhughes@cmh.edu

Susan Flack, RN CCRC

CONTACT

816-960-8904; sflack@cmh.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identity of the study article will be known only by the investigational pharmacist charged with dispensing the product and the research coordinator responsible for administering the study articles and obtaining timed blood specimens associated with pharmacokinetic and pharmacodynamic study objectives. Blinding of the principal investigator and co-investigators will be safeguarded by blinding the identity of the study articles (LTZ 0.5 mg/ml oral solution or placebo solution similar in color, flavoring and consistency) and preventing access to specific source documents that will be used for recording of collected blood samples until the time of data analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director and Associate Professor of Pediatrics

Model Details: Randomized, double-blind, placebo-controlled, crossover study

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 7, 2021
• Study Start: April 28, 2021
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)