Choosing the best research design for each question: It's time to stop squabbling over the “best” methods

Abstract

Background: Poor adherence is a key factor in poor asthma control. A connected inhaler system (CIS) comprising sensors on inhalers, a patient-facing app, and a Healthcare Professional (HCP) dashboard could improve asthma management by improving adherence. Methods: Study 207040 (NCT033800429) is one of the first to investigate the different elements of a CIS in improving adherence. The study had a 24-week, open-label, randomised, multi-centre, parallel group design with 5 treatment arms, in uncontrolled asthmatic patients [Asthma Control Test (ACT) <20] on fixed dose ICS/LABA maintenance therapy. All participants (n=437) received fluticasone furoate/vilanterol Ellipta DPI maintenance therapy, and salbutamol MDI rescue therapy with Propeller Health® sensors attached. Participants were randomised to one of 5 treatment arms: data on (1) maintenance use to participant and HCP; (2) maintenance use to participant; (3) maintenance and rescue use to participant and HCP; (4) maintenance and rescue use to participant; or (5) no data to participant or HCP (control arm). Results: The primary endpoint was the effect of 6 months’ use of a CIS on adherence to maintenance therapy assessed over months 4-6, with the absolute adjusted mean adherence difference in arm 1 (data on maintenance to participant and HCP; 82.0%) being 13.2% (95% CI [6.3%, 20.0%]; p<0.001) greater than arm 5 (control; 68.8%). For arms 2, 3 and 4 the adjusted mean differences were 9.0%, 9.8% and 8.9% respectively versus arm 5 (all statistically significant at the 5% level). Conclusion: The study demonstrates that a CIS can improve adherence to maintenance medication for patients with uncontrolled asthma. Funding: GlaxoSmithKline plc. (207040)