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 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT04179461
Eligibility Criteria:
Inclusion Criteria:
* History of provider-diagnosed asthma
* Meets one of the following definition for NAEPP guidelines uncontrolled moderate persistent asthma or severe persistent asthma in the past 12 months:
* NAEPP step 3-4 with one of the following criteria in the past 12 months:
* Two Asthma Control Test (ACT) scores \<20
* 1 Urgent Care or Emergency Department visit or hospitalization for asthma
* \>2 prednisone bursts
* NAEPP step 5-6
* Current health insurance coverage at enrollment. This will be verified at V1 at the registration desk. If the family loses insurance during the study, the patient will be referred to the pulmonary social worker and financial office for assistance
* Reside at a primary home on average 5 out of 7 days a week.
* Primary home is within a 40 mile radius of Cincinnati Children's Base location or PI's discretion.
Exclusion Criteria:
* Received biologic therapy 6 months prior to enrollment
* Received systemic steroids 6 weeks prior to enrollment
* Active chronic disease apart from asthma or allergic disease
* Co-morbid lung disease
* Dependence on immunosuppressive drugs for a condition other than asthma
* Participant is pregnant
* Has a severe bleeding disorder
* Has significant developmental disability
* Share a bedroom with a currently enrolled Breath Warriors study participant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT04179461
Study Brief:
Protocol Section:
NCT04179461