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Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma

ConditionsAsthma (Diagnosis)Inhaler TechniquePediatric Asthma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorUniversity Medical Center Groningen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Chronic lung disease other than asthma

Significant cardiac disease

Not able to understand Dutch sufficiently

No access to stable mobile internet

Trial design

Design model

Single group

Treatments tested in this trial

  • Aflo™ Smart Spacer

    Device

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Aflo™ Smart Spacer PlatformExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

Asthma Control Test (ACT)

childrens ACT score change over time

Time frame
Baseline vs. week 12
2

Change in FEV1/FVC ratio

Change in FEV1/FVC ratio (%) from baseline to 3 months.

Time frame
Baseline vs. week 12
3

Change in FEF25-75

Change in FEF25-75 (L/s) from baseline to 3 months.

Time frame
Baseline vs. week 12
4

Change in FEF75

Change in FEF75 (L/s) from baseline to 3 months.

Time frame
Baseline vs. week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: