Towards Digital Management of Paediatric Asthma (FrenchCare)

Towards Digital Management of Pediatric Asthma:a Pilot Study

This pilot study aims to explore whether a digital approach to managing childhood asthma using connected inhalers and video consultations triggered by alerts from these devices - could work as well as standard in-person care. The connected inhalers track when children use their daily prevention medication and their rescue medication for asthma symptoms. If a child misses several days of prevention medication or uses their rescue inhaler frequently, their doctor receives an alert and can schedule a video consultation to adjust their treatment. Fifty children aged 4-12 years with asthma will participate for 8 months, with half using this digital system and half receiving usual care. The study will measure whether this new approach is practical and acceptable to families and doctors, and will look at its effects on asthma control, quality of life, and healthcare use. The results will help design a larger study to fully test if this digital approach could improve asthma care for children.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Asthma
• Intervention / Treatment: Device: Active telemonitoring using real-time data from digital inhalers.; Other: Standard

Detailed Description

Asthma is the most common chronic illness in children. In France, two-thirds of children have uncontrolled asthma, meaning they experience symptoms and occasional asthma attacks.

The digital revolution has enabled the development of connected devices, particularly smart inhalers, which collect objective information for assessing asthma from patients' homes. The Covid-19 pandemic has further accelerated the adoption of telemedicine. These new approaches represent a significant shift in paediatric asthma management, offering opportunities for more effective treatment methods.

As a precursor to a larger investigation, this pilot study hypothesises that digital asthma management using proactive remote care through telemedicine consultations triggered by connected device alerts may improve childhood asthma control compared to current management approaches.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David DUMMOND, MD, PhD; Phone Number: +33 01 87 89 20 28; Email: david.drummond@aphp.fr
• Study Contact Backup: Name: sarah BOUCHARD, Project manager; Phone Number: +33 01 42 19 28 79; Email: sarah.bouchard@ahp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hôpital Necker Enfants Malades AP-HP
    • Contact: David DUMMOND, MD, PhD; Phone Number: +33 01 87 89 20 28; Email: david.drummond@aphp.fr
    • Contact: Sarah BOUCHARD, Project advisor; Phone Number: +33 01 42 19 28 79; Email: sarah.bouchard@aphp.fr
    • Principal Investigator: David DUMMOND, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital medicine; Active telemonitoring using real-time data from digital inhalers	Device: Active telemonitoring using real-time data from digital inhalers.; Telemonitoring system relying on the use of 2 digital inhalers FindAir ONE for pMDI, one for the controller the other for the reliever treatment. Active telemonitoring using real-time data from digital inhalers. Investigators will be alerted by email if a child: fails to take his or her controller treatment for 4 continuous days and/or; uses > 4 doses of reliever treatment over 24 hours; uses < 12 doses of reliever treatment over 3 months (indication to decrease the controller treatment) In these cases, investigators will be asked to schedule a teleconsultation within 2 working days with the family and to adapt treatments as needed. They may ask the family to use the portable spirometer and oximeter if necessary. No systematic consultation will be planned.
Active Comparator: Standardized medicine; The patients are monitored as usual according to the standard care protocol. Patients will receive 2 digital inhalers, but only to record their treatment use.	Other: Standard; Standardized care + passive recording of asthma treatment use (controller and reliever treatments) using digital inhalers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in asthma severity measured by the Composite Asthma Severity Index (CASI)	The CASI is a validated composite score that evaluates asthma severity by incorporating measures of asthma symptoms, exacerbations, lung function, and treatment level. The change in CASI score will be compared between groups, calculated as the difference between the final score (at 8 months) and the baseline score. Lower scores indicate less severe asthma. The CASI ranges from 0 to 17, with higher scores meaning a higher severity (worse outcome).	At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	The adherence of patients to their maintenance treatment, automatically recorded via digital inhalers, defined as the number of doses taken divided by the number of doses prescribed x 100: average percentage of adherence	During the eight-month follow up period in each group
Reliever treatment	Use of reliever treatment (salbutamol) is automatically recorded via digital inhalers: average number of uses per each patient	During the eight-month follow up period in each group
Number of teleconsultations/consultations	Average number of consultations/teleconsultations per patient, scheduled and unscheduled, and their average cumulative duration per patient	During the eight-month follow up period in each group
Children's lung function	Evolution of lung function assessed by the predicted percentage of the forced expiratory volume in one second (FEV1) in children aged 7 to 12 years	At the inclusion visit (baseline) and 8 months (+/- 1 month) (end study) in each group
Severe exacerbations requiring oral steroids	Severe exacerbations (defined as an exacerbation requiring oral corticosteroid therapy): number of severe exacerbations per patient and percentage of patients with at least one severe exacerbation	During the eight-month follow up period in each group
Severe exacerbations requiring emergency department visit and/or hospital admission.	Severe exacerbations requiring emergency department visits and/or hospitali admission: number per patient and percentage of patients with at least one	During the eight-month follow up period in each group
Quality of life questionnaire	Children (aged 7 -12 years) were assessed by the mini Pediatric Asthma Quality of Life Questionnaire (mPAQLQ). Their parents were assessed by the Pediatric Asthma Caregivers' Quality of Life.	At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group
Children participation	The child's speaking time compared to the total speaking time (child + parent + doctor), expressed as a percentage was determined from video recordings. The number of the child's speech turns compared to the total number of speech turns (child + parent + doctor), expressed as a percentage. The number of complete thoughts, or "utterances", of the child compared to the total number of complete thoughts, expressed as a percentage. The child's non-verbal communication, analyzed by a module of the Roter Interactive Assessment System	During the eight-month follow up period in each group
Absenteeism	Number of days of asthma-related absenteeism (from school for children and work for parents), per patient	During the eight-month follow up period in each group
Satisfaction of parents	Assessed by the proportion of parents in the experimental group responding on a custom questionnaire that they wish to continue the digital management experience and the reason for their choice	After 8 months (+/- 1 month) (end of study)
Satisfaction of doctors	Assessed by the proportion of doctors in the experimental group responding on a custom questionnaire that they wish to continue the digital management experience and the reason for their choice	After 8 months (+/- 1 month) (end of study)
Asthma control	Evolution in the overall Childhood Asthma Control Test (c-ACT) score. The c-ACT (Childhood Asthma Control Test) will be used to evaluate the evolution of asthma control. The c-ACT ranges from 0 min to 27 max, with higher scores meaning better asthma control (better outcome).	At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: David DUMMOND, MD, PhD, Hôpital Necker Enfants Malades AP-HP

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric asthma; Digital revolution; Digital inhaler
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: APHP211434; ID-RCB Number:2022-A02649-34 (Other Identifier: ID-RCB Number:2022-A02649-34)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No