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Skin test may personalize asthma care for kids

NCT ID NCT04699604

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether a skin test that measures histamine response can help doctors decide if adding an antihistamine (Levocetirizine) to standard asthma treatment improves control in children aged 6-17 with allergic asthma. About 300 African American/Black and Caucasian/White children will be randomly assigned to receive either the antihistamine or a placebo for 6 weeks, then switch. The goal is to see if the skin test predicts who benefits most from antihistamine therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levocetirizine (Xyzal)
What this could lead to
If successful, this could provide a simple skin test to identify which children with allergic asthma would benefit from adding an antihistamine to their current treatment.
What could go wrong
This is a Phase 3 trial, but it is still testing a biomarker approach. The antihistamine may not improve asthma control for all children, and results may vary by race or phenotype.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

55 people

The number who actually took part.

Started

Apr 2021

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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) Exclusion Criteria: 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: Have you ever been diagnosed with chronic kidney disease?; Have you ever had to be on dialysis or take medications for chronic kidney disease?) 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

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