NCT04942639

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

Phase 3, Multi-centre, Prospective, Open, Randomized, in Two Parallel Groups Study to Evaluate Efficacy and Tolerance of Patient's Learning in Self-taking of Prescribed Asthma Maintenance Treatments and Provided by a Robot Named JOE.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Ludocare SAS · Industry
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Asthma in Children

Interventions

Type	Name	Description
DEVICE	JOE	Audiovisual support by the robot when taking maintenance treatments at home.

Timeline

• Start date: 2022-10-18
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-06-28
• Last updated: 2024-02-29

Locations

13 sites across 1 country: France