Effectiveness of a Maintenance and Reliever Digihaler System in Asthma: 24-Week Randomized Study (CONNECT2)

Abstract

BACKGROUNDDigital health tools have been shown to help address challenges in asthma control, including inhaler technique, treatment adherence and short-acting beta2-agonist overuse. The maintenance and reliever Digihaler System (DS) comprises two Digihaler inhalers (fluticasone propionate/salmeterol and albuterol) with an associated patient App and web-based Dashboard. Clinicians can review patients’ inhaler use and Digihaler inhalation parameter data to support clinical decision-making. OBJECTIVECONNECT2 evaluated asthma control in participants using the DS versus standard-of-care (SoC) maintenance and reliever inhalers. METHODSParticipants (≥13 years) with uncontrolled asthma (Asthma Control Test [ACT] score <19) were randomized 4:3 (open-label) to the DS (n = 210) or SoC (n = 181) for 24 weeks. The primary endpoint was the proportion of patients achieving well-controlled asthma (i.e., an ACT score ≥20 or increase from baseline of ≥3 units at Week 24). RESULTSThere was an 88.7% probability that participants using the DS would have greater odds of achieving improvement in asthma control compared with SoC after 24 weeks. Mean odds ratio (95% credible interval) for DS versus SoC was 1.35 (0.846–2.038), indicating a 35% higher odds of improved asthma control with the DS. The DS group had more clinician-participant interactions versus SoC, mainly addressing poor inhaler technique. DS participants’ maintenance treatment adherence was good (Month 1: 79.2%; Month 6: 68.6%); reliever use decreased by 38.2% versus baseline. App and Dashboard usability were rated ‘good’. CONCLUSIONThe positive results in asthma control in this study after 24 weeks demonstrate the effectiveness of the DS in asthma management.