Evaluation of Efficacy and Tolerance of JOE on 4 to 11 Years Old Asthmatic Patients of GINA 2,3,4 and 5 Grades (JoeCare)

Ludocare

Status

Active, not recruiting

Conditions

Asthma in Children

Treatments

Device: JOE

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04942639

Asthma JoeCare

2021-A00350-41 (Other Identifier)

Details and patient eligibility

About

The main objective of this study is to evaluate efficacy and safety of patient's learning in self-taking of prescribed asthma maintenance treatments and provided by JOE (a new DTX), on the number of severe exacerbations in children with an asthma graded 2, 3, 4 and 5 according to GINA classification.

Full description

A new device, named JOE, manufactured by Ludocare, is available since 2019 in France. This new device, compact and connected, was designed to be easy to use by children suffering from chronic disease. JOE is a robot designed to improve compliance with asthama maintenance treatments.To confirm efficacy and safety of a patient's learning in self-taking of asthma maintenance treatments provided by JOE, it has been decided to carry out a clinical study in 4 to 11 years old patients and suffering from asthma graded 2, 3, 4 or 5 according to GINA classification. These patients will be recruited by pneumo-pediatricians at hospital or in private practice. The study is a phase 3, multi-center, prospective, open, 2-parallel groups, randomized and controlled study. Each patient will be randomly allocated in one of two studied treatment groups: standard asthma maintenace treatment (group SCT) vs standard asthma maintenance treatment + JOE (a new DTx) (group SCT + JOE). Patients meeting eligible criteria will be included at Day 0 (Visit V0). For each patient the maximal duration of this study will be 12 months. At day 7 a phone call is planned to evaluate patient/parent's motivation and to detect potential technical and/or therapeutic problems. Three visits are planned then after at4 (M4), 8 (M8) and 12 (M12) months.

Enrollment

213 patients

Sex

All

Ages

4 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

4-11years old,
able to use JOE
persistent uncontrolled asthma, graded 2, 3 , 4 or 5 on GINA classification
maintenance treatment since at least 3 months
having given their informed written consent

Exclusion criteria

asthma naïve-treatment child
without regular follow-up with the investigator
participating to another interventional study, with another disease, other treatments or planned modification of prescribed treatments that could interfere with studied disease