Pediatric AsthmaFrenchCareNCT06902766
Towards Digital Management of Paediatric Asthma
A study testing Active telemonitoring using real-time data from digital inhalers. and Standard in people with Pediatric Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pediatric Asthma
- What is being tested?
- Active telemonitoring using real-time data from digital inhalers. and Standard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2025to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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):
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- 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
Who cannot join
- Patient who did not use the system within 15 days of the inclusion visit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker Enfants Malades AP-HP
Paris, 75015
David DUMMOND, MD, PhD, 01 87 89 20 28 ext. +33, david.drummond@aphp.fr
Sarah BOUCHARD, Project advisor, 01 42 19 28 79 ext. +33, sarah.bouchard@aphp.fr
About this study
Official title: Towards Digital Management of Pediatric Asthma:a Pilot Study
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.
Read the 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.
- Conditions
- Pediatric Asthma
- Being tested
- Active telemonitoring using real-time data from digital inhalers., Standard
- Keywords
- Pediatric asthma, Digital revolution, Digital inhaler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active telemonitoring using real-time data from digital inhalers.Device
Telemonitoring system relying on the use of 2 digital inhalers FindAir ONE for pMDI,one for the controller the other for the reliever treatment.
Active telemonitoring using real-time data from digital inhalers Investigators will be alerted by email if a child:
- fails to take his or her controller treatment for 4 continuous days and/or
- uses > 4 doses of reliever treatment over 24 hours
- uses < 12 doses of reliever treatment over 3 months (indication to decrease the controller treatment).
For alert (2), a teleconsultation will be scheduled within 2 working days to assess and adapt treatment as needed. Emergency treatment may be adjusted for approximately one week. Alerts within the following 7 days will be considered part of the same clinical episode.
For alerts (1) and (3), a teleconsultation will be scheduled within 7 working days to assess and adapt management as needed.Spirometry and pulse oximetry if needed.
StandardOther
Standardized care + passive recording of asthma treatment use (controller and reliever treatments) using digital inhalers
| Study group | Role | What they receive |
|---|---|---|
| Digital medicine | Experimental | Active telemonitoring using real-time data from digital inhalers Receives: Device: Active telemonitoring using real-time data from digital inhalers. |
| Standardized medicine | Active comparator | 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. Receives: Other: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asthma severity measured by the Composite Asthma Severity Index (CASI)
The CASI is a validated composite score that evaluates asthma severity by incorporating measures of asthma symptoms, exacerbations, lung function, and treatment level. The change in CASI score will be compared between groups, calculated as the difference between the final score (at 8 months) and the baseline score. Lower scores indicate less severe asthma.
The CASI ranges from 0 to 17, with higher scores meaning a higher severity (worse outcome).
Measured: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group
Secondary outcomes (12)
Asthma control
Evolution in the overall Childhood Asthma Control Test (c-ACT) score. The c-ACT (Childhood Asthma Control Test) will be used to evaluate the evolution of asthma control.
The c-ACT ranges from 0 min to 27 max, with higher scores meaning better asthma control (better outcome).
Measured: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group
Severe exacerbations requiring oral steroids
Severe exacerbations (defined as an exacerbation requiring oral corticosteroid therapy): number of severe exacerbations per patient and percentage of patients with at least one severe exacerbation
Measured: During the eight-month follow up period in each group
Severe exacerbations requiring emergency department visit and/or hospital admission.
Severe exacerbations requiring emergency department visits and/or hospitali admission: number per patient and percentage of patients with at least one
Measured: During the eight-month follow up period in each group
Children's lung function
Evolution of lung function assessed by the predicted percentage of the forced expiratory volume in one second (FEV1) in children aged 7 to 12 years
Measured: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end study) in each group
Quality of life questionnaire
Children (aged 7 -12 years) were assessed by the mini Pediatric Asthma Quality of Life Questionnaire (mPAQLQ). Their parents were assessed by the Pediatric Asthma Caregivers' Quality of Life.
Measured: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group
Adherence
The adherence of patients to their maintenance treatment, automatically recorded via digital inhalers, defined as the number of doses taken divided by the number of doses prescribed x 100: average percentage of adherence
Measured: During the eight-month follow up period in each group
Reliever treatment
Use of reliever treatment (salbutamol) is automatically recorded via digital inhalers: average number of uses per each patient
Measured: During the eight-month follow up period in each group
Number of teleconsultations/consultations
Average number of consultations/teleconsultations per patient, scheduled and unscheduled, and their average cumulative duration per patient
Measured: During the eight-month follow up period in each group
Children participation
The child's speaking time compared to the total speaking time (child + parent + doctor), expressed as a percentage was determined from video recordings.
The number of the child's speech turns compared to the total number of speech turns (child + parent + doctor), expressed as a percentage.
The number of complete thoughts, or "utterances", of the child compared to the total number of complete thoughts, expressed as a percentage.
The child's non-verbal communication, analyzed by a module of the Roter Interactive Assessment System
Measured: During the eight-month follow up period in each group
Absenteeism
Number of days of asthma-related absenteeism (from school for children and work for parents), per patient
Measured: During the eight-month follow up period in each group
Satisfaction of parents
Assessed by the proportion of parents in the experimental group responding on a custom questionnaire that they wish to continue the digital management experience and the reason for their choice
Measured: After 8 months (+/- 1 month) (end of study)
Satisfaction of doctors
Assessed by the proportion of doctors in the experimental group responding on a custom questionnaire that they wish to continue the digital management experience and the reason for their choice
Measured: After 8 months (+/- 1 month) (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start25 Nov 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- David DUMMOND, MD, PhD, Principal investigator, Hôpital Necker Enfants Malades AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902766
- Sponsor's protocol ID
- APHP211434
- Other IDs
- ID-RCB Number:2022-A02649-34
- Acronym
- FrenchCare
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No