RT Journal Article
SR Electronic
T1 Use of digital measurement of medication adherence and lung function to guide the management of uncontrolled asthma: The INCA Sun randomized clinical trial
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP RCT4446
DO 10.1183/13993003.congress-2022.RCT4446
VO 60
IS suppl 66
A1 Richard Costello
A1 Liam Heaney
A1 Des Murphy
A1 Elaine Machale
YR 2022
UL http://erj.ersjournals.com/content/60/suppl_66/RCT4446.abstract
AB 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 EnglandParticipants: 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, NCT02307669FootnotesCite this article as Eur Respir J 2022; 60: Suppl. 66, RCT4446.This article was presented at the 2022 ERS International Congress, in session “ALERT 1: COPD and hospital management”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).