Use of digital measurement of medication adherence and lung function to guide the management of uncontrolled asthma: The INCA Sun randomized clinical trial

Abstract

Importance: The clinical value of using digital tools to precisely assess medication adherence and lung function is not known.

Objective: Treatment decisions guided by digitally-acquired data on adherence, inhaler technique and peak flow were compared with current methods.

Design: A 32-week multicenter randomized clinical trial comprising 3 education visits over 8 weeks, and 3 treatment adjustment visits over 24 weeks.

Setting: Ten severe asthma clinics across Ireland, Northern Ireland, and England

Participants: Patients >18 years with severe uncontrolled asthma (ACT score ≤19, ≥ 1 severe exacerbations in the last year despite daily 500-1000mcg fluticasone proprionate/LABA >12 months).

Intervention: The active group had personalized biofeedback on inhaler adherence, technique, and PEF. Treatment decisions were informed by digital data. The control group had usual care.

Results: Of the 220 patients who consented to participate, 213 were randomized (control: 105; active: 108) and 200 completed the 32-week study. At week 32, 11(11%) active and 21(21%) control patients required add-on biologic therapy OR 0.42, 95%CI [0.189-0.95], p=0.038), 3 of 19(16%) active and 11 of 25(44%) control patients who started on FP 500mcg/day were increased (OR 0.26; 95%CI [0.07–0.99], p=0.049), 26 of 83(31%) active and 13 of 73(18%) control patients were reduced to FP 500mcg/day, OR 2.11, 95%CI [1.01–4.74], p=0.047). Despite a lower treatment burden were no differences in asthma control, lung function, T2 inflammation, nor exacerbations between the two groups.

Conclusions and relevance: Evidence-based care informed by digital data is a safe cost-effective way to manage uncontrolled asthma.

Trial registration: Clinicaltrials.gov, NCT02307669