Towards Digital Management of Paediatric Asthma

NCT06902766 | Recruiting

• 2 other identifiers: APHP211434ID-RCB Number:2022-A02649-34
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Asthma

Keywords

Pediatric asthma; Digital revolution; Digital inhaler

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Asthma control

  At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group

• Severe exacerbations requiring oral steroids

  During the eight-month follow up period in each group

• Severe exacerbations requiring emergency department visit and/or hospital admission.

  During the eight-month follow up period in each group

• Children's lung function

  At the inclusion visit (baseline) and 8 months (+/- 1 month) (end study) in each group

• Quality of life questionnaire

  At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group

Study Arms (2)

Digital medicine

EXPERIMENTAL

Active telemonitoring using real-time data from digital inhalers

Device: Active telemonitoring using real-time data from digital inhalers.

Standardized medicine

ACTIVE COMPARATOR

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

Interventions

Active telemonitoring using real-time data from digital inhalers. 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.

Digital medicine

Standard OTHER

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

Standardized medicine

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Necker Enfants Malades AP-HP

Paris, 75015, France

RECRUITING

Study Officials

• David DUMMOND, MD, PhD

  Hôpital Necker Enfants Malades AP-HP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David DUMMOND, MD, PhD

CONTACT

01 87 89 20 28; david.drummond@aphp.fr

sarah BOUCHARD, Project manager

CONTACT

01 42 19 28 79; sarah.bouchard@ahp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)