Asthma (Diagnosis), Inhaler Technique, Pediatric Asthma
Conditions
Keywords
pediatric asthma, inhaler technique, medication adherence, pMDI, spacer, smart inhaler, smart spacer, digital health, aflo™
Brief summary
This pilot study evaluates the feasibility, usability, and potential effect of the aflo™ Smart Spacer platform in children aged 6-18 with uncontrolled asthma using pMDIs and spacers. The study investigates changes in inhaler technique, asthma control, and lung function following 3 months of daily use of the CE-marked aflo™ device.
Detailed description
Asthma management in children is often limited by inadequate inhaler technique and adherence. The aflo™ Smart Spacer is a CE-marked device that measures both adherence and inhaler technique, providing real-time feedback, medication reminders, and symptom tracking. This single-arm, single-center, 12-week pilot study aims to assess the platform's potential effect on inhaler technique errors, its feasibility in pediatric clinical practice, and usability. Participants will use the device for 3 months in daily life, with assessments at baseline and week 12, and phone calls at weeks 4 and 8. Findings will inform the design and sample size of a future controlled clinical trial.
Interventions
DEVICEAflo™ Smart Spacer
A CE-marked digital spacer device that measures inhaler technique (step-by-step), adherence, daily symptoms, and provides real-time feedback and reminders via a linked mobile application.
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 6-18 years * Physician-diagnosed asthma * Using ICS ± LABA ± LAMA ± SABA via pMDI and spacer suitable for aflo™ * Uncontrolled asthma (ACT \<19 and/or recent exacerbation and/or suspected nonadherence/poor technique) * Access to an Apple or Android smartphone (OS ≥ 4.3) * Willing and able to give assent/consent (parents/guardians for minors)
Exclusion criteria
* Chronic lung disease other than asthma * Significant cardiac disease * Not able to understand Dutch sufficiently * No access to stable mobile internet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inhaler technique errors | Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days) | Errors detected by aflo™ sensor relating to pMDI-spacer technique steps. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test (ACT) | Baseline vs. week 12 | childrens ACT score change over time |
| Change in FEV1/FVC ratio | Baseline vs. week 12 | Change in FEV1/FVC ratio (%) from baseline to 3 months. |
| Change in FEF25-75 | Baseline vs. week 12 | Change in FEF25-75 (L/s) from baseline to 3 months. |
| Change in FEF75 | Baseline vs. week 12 | Change in FEF75 (L/s) from baseline to 3 months. |
| Fractional exhaled nitric oxide (FeNO) | Baseline vs. week 12 | Change in FeNO |
| Proportion of prescribed inhalations taken | 3 months (from baseline to final study visit) | Adherence to inhaled medication measured as the percentage of prescribed inhalations taken over the 3-month study period. |
| Asthma exacerbations | 3 months (from baseline to final study visit) | Number of asthma exacerbations during 3 months |
| Short-acting β-agonist (SABA) use | 3 months (from baseline to final study visit) | Number of SABA puffs measured by device data |
| System Usability Scale (SUS) | SUS score measured once at week 12 (final study visit) | SUS score about the Aflo™ device |
Countries
Netherlands
Contacts
CONTACTJob F.M. van Boven, Dr
CONTACTSophie I.M. Veenstra, MSc
PRINCIPAL_INVESTIGATORJob FM van Boven, Dr
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands
PRINCIPAL_INVESTIGATORAnnelies M Zwitserloot, Dr
Department of Pediatric Pulmonology and Allergy, Beatrix Children's Hospital, University Medical Center Groningen,, Groningen, The Netherlands
Outcome results
None listed