Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma

Using the Aflo™ Digital Smart Spacer Platform to Improve Inhaler Technique in Children With Uncontrolled Asthma: A Prospective Pilot Study - INSPIRE-KIDS (INhaler SPacer Improvement & Real-time Education - KIDS)

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.

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