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Towards Digital Management of Pediatric Asthma:a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Necker Enfants Malades AP-HP
RECRUITING
Paris
Contact Information
Primary
David DUMMOND, MD, PhD
david.drummond@aphp.fr
01 87 89 20 28
Backup
sarah BOUCHARD, Project manager
sarah.bouchard@ahp.fr
01 42 19 28 79
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2027-01
Participants
Target number of participants: 50
Treatments
Experimental: Digital medicine
Active telemonitoring using real-time data from digital inhalers
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.
Related Therapeutic Areas
Sponsors
Collaborators: URC-CIC Paris Descartes Necker Cochin
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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