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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03642418
Eligibility Criteria:
Inclusion Criteria:
1. Physician-diagnosed mild or moderate persistent asthma
2. On controller therapy \[inhaled corticosteroid (ICS), ICS + leukotriene receptor antagonist (LTRA), or ICS + long-acting beta agonist (LABA)\] for at least the previous six months
3. At least one severe exacerbation requiring systemic corticosteroids in the previous year
4. Baseline FEV1 \>/= 70% predicted for age, gender, and height according to published reference standards
5. Parental consent and the child's assent
Exclusion Criteria:
1. Chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis, primary ciliary dyskinesia)
2. Severe persistent asthma, as evidenced by any of the following:
* 3 hospitalizations
* 6 severe exacerbations in the previous year on chronic oral corticosteroid therapy daily symptoms
3. Inability to perform acceptable spirometry
4. History of collapsed lung
5. History of syncope with forced exhalation
6. Not owning an iOS™ device (e.g., iPhone®, iPod®, or iPad®)
7. Lacking access to wireless local area networking (Wi-Fi™)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
15 Years
Study:
NCT03642418
Study Brief:
Protocol Section:
NCT03642418