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Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma

NCT07803042 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

  • Asthma (Diagnosis)
  • Inhaler Technique
  • Pediatric Asthma

Interventions

DEVICE

Aflo™ 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 & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Job FM van Boven, Dr · Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands

  • Annelies M Zwitserloot, Dr · Department of Pediatric Pulmonology and Allergy, Beatrix Children's Hospital, University Medical Center Groningen,, Groningen, The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-01-31
Completion
2027-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803042 on ClinicalTrials.gov