Asthma (Diagnosis)INSPIRE-KIDSNCT07803042
Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma
A study testing Aflo™ Smart Spacer in people with Asthma (Diagnosis) and Inhaler Technique, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma (Diagnosis), Inhaler Technique, Pediatric Asthma
- What is being tested?
- Aflo™ Smart Spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Chronic lung disease other than asthma
- Significant cardiac disease
- Not able to understand Dutch sufficiently
- No access to stable mobile internet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
UMC Groningen
Groningen, Provincie Groningen, 9713 GZ
Sophie I.M. Veenstra, Msc, 0031646938143, s.i.m.veenstra@umcg.nl
Job F.M. van Boven, Dr, 003150 361 7893, j.f.m.van.boven@umcg.nl
About this study
Official 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)
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.
Read the 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.
- Conditions
- Asthma (Diagnosis), Inhaler Technique, Pediatric Asthma
- Being tested
- Aflo™ Smart Spacer
- Keywords
- pediatric asthma, inhaler technique, medication adherence, pMDI, spacer, smart inhaler, smart spacer, digital health, aflo™
- Medical subject headings
- Asthma, Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflo™ Smart SpacerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aflo™ Smart Spacer Platform | Experimental | Participants receive the aflo™ device for home use during 3 months. Receives: Device: Aflo™ Smart Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inhaler technique errors
Errors detected by aflo™ sensor relating to pMDI-spacer technique steps.
Measured: Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)
Secondary outcomes (9)
Asthma Control Test (ACT)
childrens ACT score change over time
Measured: Baseline vs. week 12
Change in FEV1/FVC ratio
Change in FEV1/FVC ratio (%) from baseline to 3 months.
Measured: Baseline vs. week 12
Change in FEF25-75
Change in FEF25-75 (L/s) from baseline to 3 months.
Measured: Baseline vs. week 12
Change in FEF75
Change in FEF75 (L/s) from baseline to 3 months.
Measured: Baseline vs. week 12
Fractional exhaled nitric oxide (FeNO)
Change in FeNO
Measured: Baseline vs. week 12
Proportion of prescribed inhalations taken
Adherence to inhaled medication measured as the percentage of prescribed inhalations taken over the 3-month study period.
Measured: 3 months (from baseline to final study visit)
Asthma exacerbations
Number of asthma exacerbations during 3 months
Measured: 3 months (from baseline to final study visit)
Short-acting β-agonist (SABA) use
Number of SABA puffs measured by device data
Measured: 3 months (from baseline to final study visit)
System Usability Scale (SUS)
SUS score about the Aflo™ device
Measured: SUS score measured once at week 12 (final study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Job FM van Boven, Dr, Principal investigator, Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The NetherlandsAnnelies M Zwitserloot, Dr, Principal investigator, Department of Pediatric Pulmonology and Allergy, Beatrix Children's Hospital, University Medical Center Groningen,, Groningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803042
- Sponsor's protocol ID
- PanamaID_23081
- Acronym
- INSPIRE-KIDS
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Only aggregate results may be shared upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07803042
- Acronym / sponsor ID
- INSPIRE-KIDS / PanamaID_23081
- Conditions
- Asthma (Diagnosis), Inhaler Technique, Pediatric Asthma
- Keywords
- pediatric asthma, inhaler technique, medication adherence, pMDI, spacer, smart inhaler, smart spacer, digital health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflo™ Smart Spacer Platform | Experimental | Device: Aflo™ Smart SpacerParticipants receive the aflo™ device for home use during 3 months. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- Chronic lung disease other than asthma
- Significant cardiac disease
- Not able to understand Dutch sufficiently
- No access to stable mobile internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflo™ Smart SpacerA 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. | Device | Aflo™ Smart Spacer Platform |
Primary outcome
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.
9 secondary outcomes
Asthma Control Test (ACT)
Time frame: Baseline vs. week 12
Change in FEV1/FVC ratio
Time frame: Baseline vs. week 12
Change in FEF25-75
Time frame: Baseline vs. week 12
Change in FEF75
Time frame: Baseline vs. week 12
Fractional exhaled nitric oxide (FeNO)
Time frame: Baseline vs. week 12
Proportion of prescribed inhalations taken
Time frame: 3 months (from baseline to final study visit)
Asthma exacerbations
Time frame: 3 months (from baseline to final study visit)
Short-acting β-agonist (SABA) use
Time frame: 3 months (from baseline to final study visit)
System Usability Scale (SUS)
Time frame: SUS score measured once at week 12 (final study visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Only aggregate results may be shared upon publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Job FM van Boven, Dr principal investigator
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands
Annelies M Zwitserloot, Dr principal investigator
Department of Pediatric Pulmonology and Allergy, Beatrix Children's Hospital, University Medical Center Groningen,, Groningen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aflo™ Smart Spacer in people with Asthma (Diagnosis) and Inhaler Technique, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Job F.M. van Boven, Dr (003150 361 7893, j.f.m.van.boven@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inhaler technique errors (time frame: Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.