Towards Digital Management of Paediatric Asthma

NCT ID: NCT06902766

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-10-31

Brief Summary

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.

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.

Conditions

Pediatric Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Digital medicine

Active telemonitoring using real-time data from digital inhalers

Group Type: EXPERIMENTAL

Active telemonitoring using real-time data from digital inhalers.

Intervention Type: DEVICE

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:

1. fails to take his or her controller treatment for 4 continuous days and/or

2. uses > 4 doses of reliever treatment over 24 hours

3. 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.

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.

Group Type: ACTIVE_COMPARATOR

Standard

Intervention Type: OTHER

Standardized care + passive recording of asthma treatment use (controller and reliever treatments) using digital inhalers

Interventions

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:

1. fails to take his or her controller treatment for 4 continuous days and/or

2. uses > 4 doses of reliever treatment over 24 hours

3. 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.

Intervention Type: DEVICE

Standard

Standardized care + passive recording of asthma treatment use (controller and reliever treatments) using digital inhalers

Intervention Type: OTHER

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.

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David DUMMOND, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Necker Enfants Malades AP-HP

Locations

Hôpital Necker Enfants Malades AP-HP

Paris, , France

Countries

France

Central Contacts

David DUMMOND, MD, PhD

Role: CONTACT

david.drummond@aphp.fr

01 87 89 20 28 ext. +33

sarah BOUCHARD, Project manager

Role: CONTACT

sarah.bouchard@ahp.fr

01 42 19 28 79 ext. +33

Facility Contacts

David DUMMOND, MD, PhD

Role: primary

david.drummond@aphp.fr

01 87 89 20 28 ext. +33

Sarah BOUCHARD, Project advisor

Role: backup

sarah.bouchard@aphp.fr

01 42 19 28 79 ext. +33

Other Identifiers

ID-RCB Number:2022-A02649-34

Identifier Type: OTHER

Identifier Source: secondary_id

APHP211434

Identifier Type: -

Identifier Source: org_study_id