Towards Digital Management of Paediatric Asthma
ConditionPediatric Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Active telemonitoring using real-time data from digital inhalers.
DeviceTelemonitoring 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: 1. fails to take his or her controller treatment for 4 continuous days and/or 2. uses \> 4 doses of reliever treatment over 24 hours 3. uses \< 12 doses of reliever treatment over 3 months (indication to decrease the controller treatment) In these cases, investigators will be asked to schedule a teleconsultation within 2 working days with the family and to adapt treatments as needed. They may ask the family to use the portable spirometer and oximeter if necessary. No systematic consultation will be planned.
Standard
Other interventionStandardized care + passive recording of asthma treatment use (controller and reliever treatments) using digital inhalers
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Digital medicineExperimental treatment 1 intervention
Group B: Standardized medicineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each groupSecondary outcomes
1
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).
Time frame
At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group2
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
Time frame
During the eight-month follow up period in each group3
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
Time frame
During the eight-month follow up period in each group4
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
Time frame
At the inclusion visit (baseline) and 8 months (+/- 1 month) (end study) in each groupSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov