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Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma

Not Yet RecruitingNA

Sponsor: University Medical Center Groningen

Conditions: Asthma (Diagnosis), Inhaler Technique, Pediatric Asthma

Interventions: Aflo™ Smart Spacer

Countries: Netherlands

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.

Eligibility overview

Sex: ALL

Age: 6 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Groningen, Provincie Groningen, Netherlands