Digital management of children's asthma with connected inhalers and video visits
Towards Digital Management of Pediatric Asthma:a Pilot Study
This pilot will test whether connected inhalers that trigger doctor video consultations can help manage asthma in children aged 4–12 compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06902766 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 4–12 with physician-diagnosed asthma at GINA steps 2–4 who use pMDIs, are followed by a pediatrician or pediatric pulmonologist, have social security, and have a household smartphone with parental consent and ability to use the app.
Not a fit: Children with other significant pulmonary diseases, those who use non-pMDI inhaler devices, lack a compatible smartphone or parental ability to use the app, or whose asthma severity falls outside GINA steps 2–4 are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could allow earlier remote treatment adjustments that reduce symptoms and healthcare visits while making care more convenient for families.
How similar studies have performed: Similar smart-inhaler and telemonitoring programs have shown promising but preliminary improvements in adherence and outcomes in adult and some pediatric cohorts, so the approach is not entirely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.