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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT02298205
Eligibility Criteria:
Inclusion Criteria:
1. Patients 6-17 years old with physician diagnosed asthma for at least 6 months
2. Self or parent reported AA Race, or mixed race with at least one grandparent with AA race
3. Receiving asthma care by the participating primary care pediatrician
4. Prescribed low dose ICS monotherapy (up to Beclomethasone 160mcg for 6-11 y/o, 240 mcg per day for over 12 year old or equivalent), or leukotriene receptor antagonist (LTRA), or low dose ICS plus LABA (for over 12 year old) for at least the past 12 weeks, regardless of adherence (see ASIST low dose ICS inclusion table for conversion of dose)
5. Asthma Evaluation Questionnaire Score (AEQ)17 0 or 1 on all 3 questions
6. Pre-BD FEV1 ≥80% of predicted
7. No history or current history of smoking
8. Ability to provide baseline information at phone screening and randomization visit
9. Ability and willingness to provide informed consent
Exclusion Criteria:
1. Pre-BD FEV1\<80% of predicted within 3 months
2. Asthma requiring daily combination therapy with medium to high dose ICS with LABA
3. History of Intubation, noninvasive ventilation or ICU admission for asthma exacerbation
4. Chronic oral corticosteroid therapy
5. Chronic disease that in the opinion of the investigator/primary care provider would prevent participation in the trial
6. No landline telephone or cell phone to communicate with study staff
7. Non-English speaker
8. Another participant of ASIST in the same household
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT02298205
Study Brief:
Protocol Section:
NCT02298205