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NCT Number: NCT07803042

Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma

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.

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Key information

Conditions

Asthma (Diagnosis) Asthma Behavior Bronchial Diseases Disease Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inhaler Technique Lung Diseases Lung Diseases, Obstructive Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Pediatric Asthma Respiratory Hypersensitivity Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Asthma Control Test (ACT)

    Time frame: Baseline vs. week 12

    childrens ACT score change over time

  2. Change in FEV1/FVC ratio

    Time frame: Baseline vs. week 12

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

  3. Change in FEF25-75

    Time frame: Baseline vs. week 12

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

  4. Change in FEF75

    Time frame: Baseline vs. week 12

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

  5. Fractional exhaled nitric oxide (FeNO)

    Time frame: Baseline vs. week 12

    Change in FeNO

  6. 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.

  7. Asthma exacerbations

    Time frame: 3 months (from baseline to final study visit)

    Number of asthma exacerbations during 3 months

  8. Short-acting β-agonist (SABA) use

    Time frame: 3 months (from baseline to final study visit)

    Number of SABA puffs measured by device data

  9. System Usability Scale (SUS)

    Time frame: SUS score measured once at week 12 (final study visit)

    SUS score about the Aflo™ device

Study contacts

Contact information is provided by the study sponsor or research team.

Job F.M. van Boven, Dr

CONTACT

[email protected]

003150 361 7893

Sophie I.M. Veenstra, MSc

CONTACT

[email protected]

0031646938143

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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)

Acronym: INSPIRE-KIDS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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