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 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT06902766
Eligibility Criteria:
Inclusion Criteria:
* Aged 4 to 12, whose asthma has been diagnosed by a physician
* Followed up for their asthma by a pediatrician or pediatric pulmonologist
* With asthma severity corresponding to GINA grades 2, 3 or 4 (Global Asthma Initiative Guidelines)
* Whose controller and reliever treatments are administered using pressurized metered-dose inhalers (p-MDIs)
* With social security
* Whose parents or legal guardian(s):
* Have given their written and informed consent for their child's participation and their participation,
* Have a smartphone in the household that can download the application and is compatible with it,
* Are capable, in the opinion of the investigator, of understanding the use of the mobile application and module FRENCH CARE specifically dedicated to the research and the digital inhalers provided.
Non-inclusion Criteria:
* Patients with another pathology that could interfere with the evaluation of the endpoints (e.g, bronchopulmonary dysplasia, cystic fibrosis, etc.)
* Patients whose parents or legal representative(s) are, in the opinion of the investigator, unable to understand the purpose of the study and/or express their consent.
* Patients benefiting from State Medical Aid
Exclusion Criteria:
\- Patient who did not use the system within 15 days of the inclusion visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT06902766
Study Brief:
Protocol Section:
NCT06902766