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Levocetirizine for Allergic Asthma (HAS3 Trial)
HAS3 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.
HAS3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHAS3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HAS3 Trial Design
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Who is running the clinical trial?
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- I am a child who identifies as African American/black or Caucasian/white, including my parents and grandparents.My asthma is not well-controlled, as shown by my recent ACT score.I have a chronic lung condition other than asthma.I have taken Tricyclic Antidepressants in the last 30 days.You have shown allergic reactions in a skin or blood test.I have been diagnosed with asthma by a doctor.I am between 6 and 17 years old.I do not have chronic liver, kidney, immune, blood, or cancer conditions as decided by the study leader.You have abnormal lab test results that are important for your health, as determined by the study doctor.I am currently following a treatment plan for asthma.You have eczema on the area of your forearm where the histamine laser doppler probe will be placed on the day of the test.I am 18 years old or older.I cannot stop taking my medication that affects histamine response.You had a bad reaction to Levocetirizine (LTZ) before.I am not pregnant or breastfeeding.
- Group 1: Levocetirizine (LTZ)
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people are meeting the requirements for this clinical trial?
"Yes, the trial is still recruiting patients. According to the information on clinicaltrials.gov, this study was first posted on 4/28/2021 and was last updated on 4/26/2022. They are looking for 300 patients from 1 site."
How do I sign up for this test?
"This trial is looking for 300 participants with asthma and allergies between the ages of 6 and 17. The most important criteria for candidates are as follows: A diagnosis of asthma from a physician, uncontrolled asthma based on Asthma Control Test (ACT) score in the last 3 months or at screening, evidence of allergic sensitization from allergy skin test or allergy blood test results, currently being treated with asthma guideline-based therapy, males and females 6 through 17 years old at time of enrollment, written permission/assent to participate, children who self-identify as African American/black or Caucasian/white."
Has the FDA given the okay to market Levocetirizine?
"Levocetirizine has been studied in multiple Phase 3 clinical trials, which provides evidence of both its efficacy and safety. Therefore, our team at Power rates the safety of Levocetirizine as a 3 on our scale."
Are there any other ongoing research projects that include Levocetirizine?
"At this time, there are 2 clinical trials underway for Levocetirizine (LTZ). 1 of those is currently in Phase 3. The majority of the research being conducted on Levocetirizine (LTZ) is based in Kansas City, Missouri; however, there is 1 other location running a trial for this medication."
Are participants in this trial of age 18 years or older?
"In order for a patient to be included in this trial, they must be aged between 6 and 17 years old. Out of the 327 similar studies, 119 are for patients under 18 and 204 are for patients over 65."
For what common ailment is Levocetirizine (LTZ) most often prescribed?
"Levocetirizine is most commonly used to treat seasonal allergies, but it can also alleviate conditions like catarrh, chronic idiopathic urticaria, and nasal congestion."
Are people still being signed up for this experiment?
"Yes, this information is accurate. The study was posted on April 28th, 2021 and updated on April 26th, 2022."
What other similar medical trials have preceded this one?
"Clinical research for Levocetirizine (LTZ) started in 2009. The first large-scale study was sponsored by HK inno.N Corporation and had 100 participants. After the success of the initial Phase 4 trial, there are now 2 active studies being conducted across 1 city and 1 nation."
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