An interventional study of Aflo™ Smart Spacer in Asthma (Diagnosis), Inhaler Technique and Pediatric Asthma, sponsored by University Medical Center Groningen. Not yet recruiting at 1 site in Netherlands. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 12 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Change in inhaler technique errors
Errors detected by aflo™ sensor relating to pMDI-spacer technique steps.
Time frame: Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)
Asthma Control Test (ACT)
childrens ACT score change over time
Time frame: Baseline vs. week 12
Change in FEV1/FVC ratio
Change in FEV1/FVC ratio (%) from baseline to 3 months.
Time frame: Baseline vs. week 12
Change in FEF25-75
Change in FEF25-75 (L/s) from baseline to 3 months.
Time frame: Baseline vs. week 12
Change in FEF75
Change in FEF75 (L/s) from baseline to 3 months.
Time frame: Baseline vs. week 12
Fractional exhaled nitric oxide (FeNO)
Change in FeNO
Time frame: 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.
Time frame: 3 months (from baseline to final study visit)
Asthma exacerbations
Number of asthma exacerbations during 3 months
Time frame: 3 months (from baseline to final study visit)
Short-acting β-agonist (SABA) use
Number of SABA puffs measured by device data
Time frame: 3 months (from baseline to final study visit)
System Usability Scale (SUS)
SUS score about the Aflo™ device
Time frame: SUS score measured once at week 12 (final study visit)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No individual participant data will be shared. Only aggregate results may be shared upon publication.
Start is estimated for Sep 2026; primary completion for Jan 2027, 4 months later.
Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 4 months is below that.
Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Center Groningen →