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 aimed to improve asthma control through immediate feedback on therapy adherence and inhalation technique, with the use of a smart inhaler. METHODS: The IMAGINE (Improving Adherence by Guiding Inhalation via Electronic Monitoring) study was a randomized controlled trial consisting of 3 phases: an observational run-in phase in which adherence and technique were recorded, a randomized 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 was measured with clinical outcomes including predicted forced expiratory volume in 1 second, lung function reversibility, lung function variability, the Asthma Control Test, and the Childhood Asthma Control Test. RESULTS: Between October 2019 and October 2023, a total of 34 children were enrolled and randomized. Overall, improvements were observed at the end of phase 2 in clinical parameters (reversibility, lung function variability, Asthma Control Test, and Childhood Asthma Control Test), except for predicted forced expiratory volume in 1 second. However, no significant differences between the intervention and control groups over time were observed. At the end of phase 2, 87% (13/15) of control participants and 78% (10/13) of intervention participants met one or more predefined clinical criteria. Inhalation technique and therapy adherence did not differ over time between the groups (P=.70 and P=.14, respectively). CONCLUSIONS: While smart inhaler feedback did not lead to better outcomes compared with no feedback, clinical improvements were observed in both groups. Future studies should explore how adaptive smart inhaler interventions can be optimized to support personalized care and enhance patient ownership in asthma management. TRIAL REGISTRATION: International Clinical Trials Registry Platform NL-OMON50093; https://tinyurl.com/yws24rxy. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04694-4.