EFFECTIVENESS OF A MAINTENANCE AND RELIEVER DIGITAL SYSTEM TO IMPROVE ASTHMA CONTROL

Abstract

<h3>Introduction</h3> In the Maintenance and Reliever Digital System (MRDS), Digihaler integrated inhalers (fluticasone propionate/salmeterol and albuterol Digihalers) transmit data wirelessly to a mobile application, which synchronizes with a Digital Health Platform to store and transfer data to a web-based Dashboard. This allows patients and clinicians to track and review inhaler usage and inhalation quality as part of clinical decision making. The CONNECT2 study (NCT04677959) evaluated asthma control as measured by the Asthma Control Test (ACT) in participants using the MRDS versus participants using the standard of care (SoC) maintenance and reliever inhalers. <h3>Methods</h3> Eligible participants (≥13 years old with suboptimal asthma control [ACT score <19]) were randomized 4:3 to MRDS or SoC for 6 months. Primary outcome: the probability of greater odds for participants to achieve meaningful improvement in asthma control (ACT score ≥20, or increase ≥3 units from baseline at Month 6) with the MRDS versus SoC. Bayesian statistical analysis provided a posterior probability distribution for odds ratios with corresponding credible intervals (CrI). <h3>Results</h3> Participants using the MRDS (n=210) had an 88.7% probability of greater odds of achieving improvements in asthma control vs those using SoC (n=181) after 6 months (Figure). The mean odds ratio (95% CrI) for MRDS/SoC was 1.35 (0.846, 2.038), demonstrating that, on average, participants in the MRDS group had 35% higher odds of achieving meaningful improvement in asthma control than those in the SoC group (Figure). <h3>Conclusion</h3> After 6 months, participants using the MRDS had greater odds of clinically meaningful improvements in asthma control versus SoC.