Allergic AsthmaPhase 3HAS3NCT04699604
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
A Phase 3 study testing Levocetirizine Dihydrochloride in people with Allergic Asthma, run by Bridgette Jones at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Levocetirizine Dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 26 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma
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.
Read the detailed description
The investigator hypothesizes that children with a hyper-responsive HILD (Histamine Lontophoresis with Laser Doppler monitoring) response type are more likely to have improved asthma control after the addition of the antihistamine LTZ (Levocetirizine) to standard asthma regimen in comparison to children with hypo-responsive HILD type. This study will provide a model for a functional biomarker to inform decision making for therapeutics in children. This work is novel in testing and validating a biomarker accurately and predicting response to asthma treatment in children. This work is significant because it has the potential to alter the current treatment paradigms for children with asthma where response to treatment is predicted a priority. The proposed research will be immediately relevant by expanding knowledge in the field of asthma therapeutics by linking biologically and mechanistically based approaches to an effective and inexpensive treatment for asthma. The primary objective is to determine HILD prediction of therapeutic response in males and females 6-17 years old who identify as African American/Black and Caucasian/White to an antihistamine among children with allergic asthma, and the secondary objective is to develop a robust predictive model of therapeutic response to an antihistamine among children with allergic asthma. There will be 300 participants for approximately 17 weeks.
The primary outcome measure of therapeutic response to antihistamine will be determined by change in asthma control as guidelines recognize asthma control as a major goal of therapy. Asthma control will be determined based on the Asthma Control Test (ACT®) (children ≥ 12 years of age) or the Child-Asthma Control Test (C-ACT®) (children <12 years of age), validated measures to assess asthma control in children. Children with an ACT or C-ACT score <19 will be classified as having uncontrolled asthma. Assessments will occur at screening, visit 2, 3 and 4 (6 weeks after the participant is started on drug/placebo.) The secondary measures will include assessment of asthma impairment, risk, and quality of life. These assessments will occur at baseline/pre-dose, 6 weeks after starting drug/placebo, and 6 weeks after drug/placebo for both the LTZ and placebo arms.
The study team is utilizing HILD a surrogate marker of histamine response and will determine if HILD can predict which participants have improvement in asthma control after treatment with Levocetirizine.
- Conditions
- Allergic Asthma
- Being tested
- Levocetirizine Dihydrochloride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levocetirizine DihydrochlorideDrug
Also called Xyzal
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.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (2)
Asthma exacerbation rates
Asthma exacerbation rates will be assessed via questionnaires to assess the rate, duration, and time to first asthma exacerbation requiring systemic steroid. The investigator will also measure rates of acute office visits, emergency department/urgent care visits, and/or hospitalizations due to asthma.
Participants will also be asked to keep a daily asthma symptom diary as a secondary measure of asthma control. Asthma control days will be defined as full calendar days without asthma symptoms, rescue medication use, or unscheduled health care visits.
Participants will be asked to log asthma control and exacerbation data daily.
Measured: 6 weeks
Asthma related quality of life
Quality of life will be assessed at baseline/pre-dose and at 6 weeks after each intervention arm via the validated questionnaires, Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) and Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) to assess child and parental quality of life.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start28 Apr 2021
- Primary completion15 Apr 2026
- Study completion26 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridgette Jones
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Bridgette Jones, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699604
- Sponsor's protocol ID
- STUDY00001262
- Other IDs
- 5R01HD100545-05
- Acronym
- HAS3
- Status last verified
- Jun 2026
- First submitted
- 30 Dec 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma
- ClinicalTrials.gov ID
- NCT04699604
- Acronym / sponsor ID
- HAS3 / STUDY00001262
- Conditions
- Allergic Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Bridgette JonesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 26 Apr 2026 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigator hypothesizes that children with a hyper-responsive HILD (Histamine Lontophoresis with Laser Doppler monitoring) response type are more likely to have improved asthma control after the addition of the antihistamine LTZ (Levocetirizine) to standard asthma regimen in comparison to children with hypo-responsive HILD type. This study will provide a model for a functional biomarker to inform decision making for therapeutics in children. This work is novel in testing and validating a biomarker accurately and predicting response to asthma treatment in children. This work is significant because it has the potential to alter the current treatment paradigms for children with asthma where response to treatment is predicted a priority. The proposed research will be immediately relevant by expanding knowledge in the field of asthma therapeutics by linking biologically and mechanistically based approaches to an effective and inexpensive treatment for asthma. The primary objective is to determine HILD prediction of therapeutic response in males and females 6-17 years old who identify as African American/Black and Caucasian/White to an antihistamine among children with allergic asthma, and the secondary objective is to develop a robust predictive model of therapeutic response to an antihistamine among children with allergic asthma. There will be 300 participants for approximately 17 weeks.
The primary outcome measure of therapeutic response to antihistamine will be determined by change in asthma control as guidelines recognize asthma control as a major goal of therapy. Asthma control will be determined based on the Asthma Control Test (ACT®) (children ≥ 12 years of age) or the Child-Asthma Control Test (C-ACT®) (children <12 years of age), validated measures to assess asthma control in children. Children with an ACT or C-ACT score <19 will be classified as having uncontrolled asthma. Assessments will occur at screening, visit 2, 3 and 4 (6 weeks after the participant is started on drug/placebo.) The secondary measures will include assessment of asthma impairment, risk, and quality of life. These assessments will occur at baseline/pre-dose, 6 weeks after starting drug/placebo, and 6 weeks after drug/placebo for both the LTZ and placebo arms.
The study team is utilizing HILD a surrogate marker of histamine response and will determine if HILD can predict which participants have improvement in asthma control after treatment with Levocetirizine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, crossover study
| Arm | Type | Receives |
|---|---|---|
| Levocetirizine (LTZ) | Active comparator | Drug: Levocetirizine DihydrochlorideParticipants 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 | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levocetirizine DihydrochlorideAlso: XyzalAt 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. | Drug | Levocetirizine (LTZ) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Therapeutic response to antihistamine
Time frame: 6 weeks
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.
2 secondary outcomes
Asthma exacerbation rates
Time frame: 6 weeks
Asthma related quality of life
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levocetirizine Dihydrochloride in people with Allergic Asthma, run by Bridgette Jones at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic response to antihistamine (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.