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Antihistamine

Levocetirizine for Allergic Asthma (HAS3 Trial)

Phase 3

Recruiting

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A diagnosis of asthma based on physician diagnosis

Males and females 6 through 17 years of age at time of enrollment

Must not have

Any other chronic disease states such as history of premature lung disease, bronchiectasis, cystic fibrosis, or any chronic lung disease other than asthma

Age 18 years or older at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether the medication Levocetirizine can help improve asthma control in children who have uncontrolled persistent allergic asthma, and who are either hyperresponsive or hyporesponsive to histamine. The trial will compare results between African American/Black and Caucasian/White children.

Who is the study for?

This trial is for African American/Black and Caucasian/White children aged 6-17 with uncontrolled persistent allergic asthma, who are already on asthma treatments. They must not have significant liver, kidney, or immune diseases, be pregnant, or unable to follow the study procedures.

What is being tested?

The HAS3 trial is testing Levocetirizine (an antihistamine) against a placebo in controlling asthma symptoms. Children will be randomly assigned to receive either the medication or placebo in a blinded manner where neither they nor the researchers know which one they're getting.

What are the potential side effects?

Levocetirizine may cause side effects such as drowsiness, dry mouth, fatigue and in some cases might lead to more serious reactions like difficulty breathing or increased heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with asthma by a doctor.

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I am between 6 and 17 years old.

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I am currently following a treatment plan for asthma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a chronic lung condition other than asthma.

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I am 18 years old or older.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic response to antihistamine

Secondary study objectives

Asthma exacerbation rates

Asthma related quality of life

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Levocetirizine (LTZ)Active Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

0 / 6Eligibility criteria met