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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
UMC Groningen
Groningen, Provincie Groningen, Netherlands
Change in inhaler technique errors
Errors detected by aflo™ sensor relating to pMDI-spacer technique steps.
Time frame: Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)
Asthma Control Test (ACT)
childrens ACT score change over time
Time frame: Baseline vs. week 12
Change in FEV1/FVC ratio
Change in FEV1/FVC ratio (%) from baseline to 3 months.
Time frame: Baseline vs. week 12
Change in FEF25-75
Change in FEF25-75 (L/s) from baseline to 3 months.
Time frame: Baseline vs. week 12
Change in FEF75
Change in FEF75 (L/s) from baseline to 3 months.
Time frame: Baseline vs. week 12
Fractional exhaled nitric oxide (FeNO)
Change in FeNO
Time frame: Baseline vs. week 12
Proportion of prescribed inhalations taken
Adherence to inhaled medication measured as the percentage of prescribed inhalations taken over the 3-month study period.
Time frame: 3 months (from baseline to final study visit)
Asthma exacerbations
Number of asthma exacerbations during 3 months
Time frame: 3 months (from baseline to final study visit)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Short-acting β-agonist (SABA) use
Number of SABA puffs measured by device data
Time frame: 3 months (from baseline to final study visit)
System Usability Scale (SUS)
SUS score about the Aflo™ device
Time frame: SUS score measured once at week 12 (final study visit)