Accepted for/Published in: JMIR Pediatrics and Parenting
Date Submitted: Jun 4, 2025
Date Accepted: Oct 14, 2025
The IMAGINE Study: A Randomized Controlled Trial on the Impact of Guided Inhalation via electronic monitoring on Adherence, Inhalation Technique, and Clinical Outcomes in Children With Uncontrolled Asthma.
ABSTRACT
Background:
Pediatric asthma is the most common chronic illness among children in the Netherlands. Scheduled hospital visits provide limited insight into therapy adherence and inhalation technique, which are critical for disease control. Smart inhalers that provide immediate feedback may offer a solution for monitoring and improving these parameters at home, leading to better asthma control.
Objective:
This study aims to improve asthma control through immediate feedback on therapy adherence and inhalation technique, with the use of a smart inhaler.
Methods:
The IMAGINE study is a randomized controlled trial, consisting of three phases: an observational run-in phase in which adherence and technique are recorded, a randomised phase with feedback for the intervention group and recording for the control group, followed by an observational phase with only recording for both groups. Asthma control is measured with clinical outcomes including predicted forced expiratory volume in one second (predFEV₁), lung function reversibility, lung function variability (LFV), and asthma control (ACT and childhood ACT scores).
Results:
Between October 2019 and October 2023, 34 children were enrolled and randomized. Overall, significant improvements were observed at the end of phase 2 for both groups in clinical parameters (LFV, ACT/(c-)ACT), except for predFEV1. However, no significant differences between the intervention and control group over time were displayed. At the end of phase 2, 87% of control patients and 78% of intervention patients met one or more predefined clinical criteria. Inhalation technique and therapy adherence were not different over time between both groups.
Conclusions:
Although the trial was terminated early due to futility, both the intervention and control groups showed significant improvement in key asthma parameters (ACT, LFV, and lung function reversibility) over time. No significant differences were observed between groups. To individualize more to patient needs, adaptive and just-in-time interventions may offer an interesting approach, empowering patients to take a more ownership of their condition. Clinical Trial: NL-OMON25807
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