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:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT00860418
Eligibility Criteria:
Inclusion Criteria:
All 6 criteria must be met:
1. Physician-diagnosed asthma (based on caregiver report with validation from the child's physician)
2. \> 2 ED visits or \> 1 hospitalization for asthma within past 12 months
3. Mild persistent to severe persistent asthma based on NHLBI guidelines criteria (7-9) having any 1 of the following:
* An average of \> 2 days per week of asthma symptoms
* \> 2 days per week with rescue medication use (albuterol, xopenex) OR
* \> 2 days per month of nighttime symptoms
4. Age \> 3 and \< 10 years
5. Reside in Baltimore Metropolitan area
6. Not currently participating in another asthma study or sibling enrolled in PAAL study
Exclusion Criteria:
1. Inability to speak and understand English
2. No access to a working phone or alternate phone for follow-up surveys
3. Co-morbid respiratory condition including cystic fibrosis, chronic lung disease (BPD), lung cancer, tracheostomy that could interfere with the assessment of asthma-related outcome measures.
4. Children residing in foster care or where consent cannot be obtained from a legal guardian.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
10 Years
Study:
NCT00860418
Study Brief:
Protocol Section:
NCT00860418