Digital management of children's asthma with connected inhalers and video visits

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this 8-month pilot, 50 children aged 4–12 with physician-diagnosed asthma will be followed. Half will use connected pMDI inhaler devices that track controller and rescue use and send alerts to clinicians, and half will receive standard in-person care. Alerts for missed controller doses or frequent rescue use can prompt scheduled video consultations to adjust treatment. The study will measure feasibility and acceptability to families and clinicians and explore effects on asthma control, quality of life, and healthcare use to inform a larger trial.

Why it matters

Who can join: the full rules

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.

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

Where it's running

• Hôpital Necker Enfants Malades AP-HP
  Paris, France Recruiting

Study contacts

• Principal investigator: David DUMMOND, MD, PhD — Hôpital Necker Enfants Malades AP-HP
• Study coordinator: David DUMMOND, MD, PhD
• Email: david.drummond@aphp.fr
• Phone: 01 87 89 20 28

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.