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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT01514760
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 12 and ≤ 17 years.
* Mild to severe persistent asthma or poorly controlled asthma. If a child has used a preventive medication in the past, but reports no use of the medication in the prior 3 months, we will assess severity.
* Children not using a preventive medication at baseline: We will assess for mild persistent to severe persistent asthma. Any one of the following, during the prior 4 weeks (as defined by parent interview) will determine severity:
* An average of \>2 days per week with asthma symptoms
* \>2 days per week with rescue medication use
* ≥2 nights per month awakened with nighttime symptoms
* Minor limitation of activity
* ≥2 episodes of asthma during the past year that have required systemic corticosteroids.
* Children using a preventive medication at baseline: We will assess for poorly controlled asthma. Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting room) will determine control:
* An average of \>2 days per week with asthma symptoms
* \>2 days per week with rescue medication use
* ≥2 nights per month awakened with nighttime symptoms
* Some limitation of activity
* ≥2 episodes of asthma during the past year that have required systemic corticosteroids.
Exclusion Criteria:
* Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures.
* Significant co-morbid conditions (such as moderate to severe developmental delay, i.e. special education classroom or diagnosis) that could preclude participation in an education-based intervention.
* Inability to speak or understand English (child or parent).
* Children in foster care or other situations in which consent cannot be obtained from a guardian.
* Prior enrollment in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT01514760
Study Brief:
Protocol Section:
NCT01514760