RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

Quick Facts

Study Start:2021-04-28

Study Completion:2025-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04699604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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)	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: 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

Inclusion Criteria

Exclusion 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)

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:
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

Contacts and Locations

Study Contact

Darlene Brenson-Hughes, CCRC

CONTACT

816-731-8376

dbrensonhughes@cmh.edu

Susan Flack, RN CCRC

CONTACT

816-960-8904

sflack@cmh.edu

Study Locations (Sites)

Children's Mercy Hospital

Kansas City, Missouri, 64108

United States

Collaborators and Investigators

Sponsor: Bridgette Jones

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-28

Study Completion Date2025-05-01

Study Record Updates

Study Start Date2021-04-28

Study Completion Date2025-05-01

Terms related to this study

Additional Relevant MeSH Terms

Allergic Asthma