Real-time feedback from a smart inhaler does not improve outcomes for children with uncontrolled asthma compared to those who do not receive this feedback, according to a Dutch randomised controlled trial.
The Improving Adherence by Guiding Inhalation via Electronic Monitoring (IMAGINE) study, published in the journal JMIR Pediatrics and Parenting, assessed whether personalised, real-time guidance on inhalation technique and medication adherence could improve clinical outcomes in young people with uncontrolled moderate-to-severe asthma.
Between October 2019 and October 2023, the researchers enrolled 34 children aged six to 18 years with uncontrolled asthma as defined by a Childhood Asthma Control Test (C-ACT) score below 20 or significant bronchodilator reversibility.
Participants were randomly assigned 1:1 to an intervention group receiving feedback via the Respiro smart inhaler app or a control group where inhaler use was similarly monitored but without providing feedback.
The study comprised three phases: a four-week observational run-in, a six-week randomised phase with feedback for the intervention group only, and a further six-week observational phase with no feedback for either group.
Clinical outcomes included predicted forced expiratory volume (predFEV1) in one second, lung function reversibility, lung function variability, Asthma Control Test (ACT) and C-ACT scores. Therapy adherence and inhaler technique were secondary outcomes.
The researchers hypothesised that smart inhaler feedback group participants would more often demonstrate clinical improvement compared with participants assigned to the control group.
Smart inhaler feedback for uncontrolled asthma
Both the smart inhaler feedback group and the control group demonstrated clinical improvement by the end of the randomised phase, but no significant differences emerged between intervention and control participants across any primary outcomes.
PredFEV1 increased modestly in both groups, with no significant between-group differences. C-ACT and ACT scores rose significantly in both groups over time, indicating improved symptom control, again without superiority of the feedback intervention.
Lung function reversibility and lung function variability decreased over time in both groups, consistent with improved airway stability, but without significant between-group differences.
Overall, 78% in the intervention group and 87% of children in the control group met at least one predefined clinical improvement criterion at the end of phase 2. Inhalation technique improved across the study, particularly during the final observational phase, although the researchers noted no significant differences between groups. Therapy adherence declined over time in both groups.
The authors recognised several limitations and noted that many children had already met one or more clinical improvement criteria at baseline, restricting the potential for further improvement. Adherence to home spirometry was also suboptimal, which diminished the reliability of lung function variability as an outcome measure.
Some participants disabled the smart inhaler’s auditory reminders, although specific data on this were not available.
The trial was terminated early after a planned interim analysis, which significantly reduced its statistical power. Additionally, because the control group also received smart monitoring without feedback, potential differences between arms may have been minimised, the researchers said.
Future research and clinical implications
Despite these limitations, the researchers that smart inhalers may still offer value in supporting personalised paediatric asthma care by providing objective insights into inhaler use.
They proposed that future studies examine adaptive, just-in-time feedback strategies that respond to individual deterioration in asthma control, rather than delivering continuous reminders via a smart inhaler.
Further suggestions include refining assessment criteria and developing more intuitive, child-friendly feedback systems to strengthen engagement and support patient ownership in asthma management.
Reference
Sportel E et al. Guided Inhalation via Electronic Monitoring in Children With Uncontrolled Asthma (the IMAGINE Study): Randomized Controlled Trial. JMIR Pediatr Parent 2025;8:e78526.
