Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma (INSPIRE-KIDS)

August 31, 2026 updated by: University Medical Center Groningen

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9713 GZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aflo™ Smart Spacer Platform
Participants receive the aflo™ device for home use during 3 months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inhaler technique errors
Time Frame: Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)
Errors detected by aflo™ sensor relating to pMDI-spacer technique steps.
Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Test (ACT)
Time Frame: Baseline vs. week 12
childrens ACT score change over time
Baseline vs. week 12
Change in FEV1/FVC ratio
Time Frame: Baseline vs. week 12
Change in FEV1/FVC ratio (%) from baseline to 3 months.
Baseline vs. week 12
Change in FEF25-75
Time Frame: Baseline vs. week 12
Change in FEF25-75 (L/s) from baseline to 3 months.
Baseline vs. week 12
Change in FEF75
Time Frame: Baseline vs. week 12
Change in FEF75 (L/s) from baseline to 3 months.
Baseline vs. week 12
Fractional exhaled nitric oxide (FeNO)
Time Frame: Baseline vs. week 12
Change in FeNO
Baseline vs. week 12
Proportion of prescribed inhalations taken
Time Frame: 3 months (from baseline to final study visit)
Adherence to inhaled medication measured as the percentage of prescribed inhalations taken over the 3-month study period.
3 months (from baseline to final study visit)
Asthma exacerbations
Time Frame: 3 months (from baseline to final study visit)
Number of asthma exacerbations during 3 months
3 months (from baseline to final study visit)
Short-acting β-agonist (SABA) use
Time Frame: 3 months (from baseline to final study visit)
Number of SABA puffs measured by device data
3 months (from baseline to final study visit)
System Usability Scale (SUS)
Time Frame: SUS score measured once at week 12 (final study visit)
SUS score about the Aflo™ device
SUS score measured once at week 12 (final study visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Job FM van Boven, Dr, Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands
  • Principal Investigator: Annelies M Zwitserloot, Dr, Department of Pediatric Pulmonology and Allergy, Beatrix Children's Hospital, University Medical Center Groningen,, Groningen, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

August 25, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PanamaID_23081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared. Only aggregate results may be shared upon publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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