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Smart spacer device aims to fix Kids' inhaler mistakes

NCT ID NCT07803042

Disease control Sponsor: University Medical Center Groningen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This pilot study tests a digital spacer device called aflo™ in children aged 6 to 18 with uncontrolled asthma. The device attaches to a standard inhaler and gives real-time feedback on technique, reminders, and tracks symptoms through a mobile app. Researchers want to see if using it daily for three months improves inhaler technique, asthma control, and lung function. The study focuses on whether the device is practical and helpful for children and their families.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aflo™ Smart Spacer, a digital device that attaches to an inhaler and provides step-by-step feedback via a mobile app
What this could lead to
If it works, this device could help children with asthma use their inhalers correctly, leading to better asthma control and fewer symptoms.
What could go wrong
This is a small pilot study with only 12 children, so results may not apply broadly. The device may not be easy for all children to use, and it does not replace standard asthma medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

asthma childhood onset asthma disease Medication Adherence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma (diagnosis) Inhaler technique Pediatric asthma

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • UMC Groningen

    Groningen, Provincie Groningen, 9713 GZ, Netherlands

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