Clinical trial NCT04942639: Evaluation of Efficacy and Tolerance of JOE on 4 to 11 Years Old Asthmatic Patients of GINA 2,3,4 and 5 Grades
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma in Children
Keywords: Asthma, Children, Prevention, Severe Asthma Exacerbations
Lead sponsor: Ludocare SAS
Sponsor class: INDUSTRY
Collaborators: name: Clinact
First posted: 2021-06-28
Enrollment: 213
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel groups: Standard Asthma Maintenance Treatment (SAMT) vs SAMT + Joe robot (a new DTX)
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the mean number of severe asthma exacerbations per patient between the two treatment groups during the 12-month follow-up.
timeFrame: 12 months
Secondary outcomes:
measure: Effectiveness of the maintenance treatment measured with c-ACT
timeFrame: 12 months
measure: Tolerance to the maintenance treatment evaluated by the number and type of adverse events
timeFrame: 12 months
measure: Global costs estimation evaluated by price
timeFrame: 12 months
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Cabinet de pneumologie pédiatrique La Fourane
city: Amiens
country: France
facility: CHU Amiens
city: Boulogne-Billancourt
country: France
facility: APHP - Hôpital Ambroise Paré
city: Brest
country: France
facility: CHRU Morvan
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Créteil
country: France
facility: CHI Créteil
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
city: Marseille
country: France
facility: CH Saint Joseph
city: Montluçon
country: France
facility: Cabinet Medeo
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Paris
country: France
facility: APHP - Hôpital Armand Trousseau
city: Paris
country: France
facility: APHP - Hôpital Robert Debré
Study officials:
References: