Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT04699604
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT04699604
Study Brief:
Protocol Section:
NCT04699604