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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01175434
Eligibility Criteria:
Inclusion Criteria (all 4 criteria must be met):
1. Physician-diagnosed asthma (based on parent report).
2. Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following:
1. An average of \>2 days per week with asthma symptoms
2. \>2 days per week with rescue medication use
3. \>2 days per month with nighttime symptoms
4. ≥2 episodes of asthma during the past year that have required systemic corticosteroids
3. Age ≥3 and ≤10 years.
4. Attending school in participating Rochester City School District preschools or elementary schools.
Exclusion Criteria:
1. Inability to speak and understand English. (\*Parents unable to read will be eligible, and all instruments will be given verbally.)
2. No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number).
3. Family planning to leave the school district within fewer than 6 months.
4. The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
5. Children in foster care or other situations in which consent cannot be obtained from a guardian.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
10 Years
Study:
NCT01175434
Study Brief:
Protocol Section:
NCT01175434