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NCT06902766 | NOT YET RECRUITING | Pediatric Asthma

Towards Digital Management of Paediatric Asthma
Sponsor:

Public assistance - Paris hospitals

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.

Condition or disease

Pediatric Asthma

Intervention/treatment

Telemonitoring system relying on the use of 2 digital inhalers FindAir ONE for pMDI, one for the controller the other for the reliever treatment

Phase

NA

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
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Towards Digital Management of Pediatric Asthma:a Pilot Study
Actual Study Start Date : 2025-10
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 4 Years to 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Aged 4 to 12, whose asthma has been diagnosed by a physician
  • * Followed up for their asthma by a paediatrician or paediatric 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 of it's 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
Towards Digital Management of Paediatric Asthma

Location Details

NCT06902766

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Necker Hospital Malades

Paris, France, 75015