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

BACKGROUND: Digital health tools have been shown to help address challenges in asthma control, including inhaler technique, treatment adherence and short-acting beta 2 -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.OBJECTIVE: CONNECT2 evaluated asthma control in participants using the DS versus standard-of-care (SoC) maintenance and reliever inhalers.METHODS: Participants (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 24weeks.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). RESULTS:There 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'. CONCLUSION:The positive results in asthma control in this study after 24 weeks demonstrate the effectiveness of the DS in asthma management.