Towards Digital Management of Paediatric Asthma

Study acronym: FrenchCare
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jan 2027 → Jul 2027
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Record History

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  1. Primary and study completion pushed from Jan 2027 to Jul 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 8 of 12 entries
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 5 more changesShow less
    • Primary completion date: Oct 2025 to Jan 2027
    • Study completion date: Oct 2026 to Jan 2027
    • Start date changed from estimate of Oct 2025 to Nov 25, 2025
    • Site details revised
    • Collaborators expanded, about 5 words
  3. Secondary endpoints: details revised at 1 of 12 entriesv4
  4. Interventions: Telemonitoring system relying on the use of 2 digital inhalers FindAir ONE for pMDI, one for the controller the other for the reliever… to Active telemonitoring using real-time data from digital inhalers. (Device), Standard (Other)
    • Secondary endpoints: 11 to 12
    • Study site revised
    • Eligibility criteria shortened, about 2 words
    v3
  5. Secondary endpoints: details revised at 3 of 11 entries
    • Site contact updated
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06902766
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions
(from sponsor)		 Pediatric Asthma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov