A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients

Alison Moore, Andrew Preece, Raj Sharma, Liam G. Heaney, Richard W. Costello, Robert A. Wise, Andrea Ludwig-Sengpiel, Giselle Mosnaim, Jamie Rees, Ryan Tomlinson, Ruth Tal-Singer, David A. Stempel, Neil Barnes

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Abstract

Suboptimal adherence to maintenance therapy contributes to poor asthma control and exacerbations. This study evaluated the effect of different elements of a connected inhaler system (CIS), comprising clip-on inhaler sensors, a patient-facing app, and a healthcare professional (HCP) dashboard, on adherence to asthma maintenance therapy.This was an open-label, parallel-group, 6-month, randomised controlled trial in adults with uncontrolled asthma (Asthma Control Test (ACT) score <20) on fixed-dose inhaled corticosteroid/long-acting beta-agonist maintenance therapy (n=437). All received fluticasone furoate/vilanterol ELLIPTA dry powder maintenance and salbutamol/albuterol metered dose rescue inhalers with a sensor attached to each inhaler. Participants were randomised to one of five CIS study arms (1:1:1:1:1) reflecting the recipient of the data feedback from the sensors: 1) Maintenance use to participants and HCPs (N=87); 2) Maintenance use to participants (N=88); 3) Maintenance and rescue use to participants and HCPs (N=88); 4) Maintenance and rescue use to participants (N=88); 5) No feedback (control) (N=86).For the primary endpoint, observed mean adherence (sd) to maintenance therapy over months 4-6, was 82.2% (16.58) (n=83) in the "maintenance to participants and HCPs" arm and 70.8% (27.30) (n=85) in the control arm and the adjusted LS mean (se) was 80.9% (3.19) and 69.0% (3.19), respectively (study arm difference: 12.0% (95% CI: 5.2%, 18.8%; p<0.001)). Adherence was also significantly greater in the other CIS arms versus control. Mean percentage of rescue medication-free days (months 4-6) was significantly greater in participants receiving data on their rescue use compared with control. ACT scores improved in all study arms with no significant differences between groups.A CIS can improve adherence to maintenance medication and reduce rescue medication use in patients with uncontrolled asthma.

Original languageEnglish
Article number2003103
JournalEuropean Respiratory Journal
Volume57
Issue number6
DOIs
Publication statusPublished - 04 Jun 2021

Bibliographical note

Funding Information:
Conflict of interest: A. Moore reports study funding and non-financial (writing) support from GlaxoSmithKline, during the conduct of the study; and is an employee of and holds shares/options in GlaxoSmithKline. A. Preece reports study funding and non-financial (writing) support from GlaxoSmithKline, during the conduct of the study; and is an employee of and holds shares/options in GlaxoSmithKline. R. Sharma reports study funding and non-financial (writing) support from GlaxoSmithKline, during the conduct of the study; and is an employee of and holds shares/options in GlaxoSmithKline. L.G. Heaney is lead for the UK MRC Consortium for Stratified Medicine in Severe Asthma with Amgen, AstraZeneca, Medimmune, Janssen, Novartis, Roche/Genentech, GlaxoSmithKline plc., Boehringer Ingelheim, Aerocrine and Vitalograph as industry partners; has received support for advisory boards/lectures from Novartis, Hoffman la Roche/Genentech Inc, Evelo Biosciences, Sanofi, GlaxoSmithKline, AstraZeneca, Teva, Theravance and Circassia; has received travel funding support for international respiratory meeting attendance (institution remunerated) from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK and Napp Pharmaceutical; project grant funding from Medimmune, Novartis UK, Roche/Genentech, and GlaxoSmithKline plc.; and has participated in clinical trials for which their institution was remunerated from AstraZeneca, GlaxoSmithKline, Schering Plough, Synairgen, Novartis and Roche/ Genentech, outside the submitted work. R.W. Costello reports grants and personal fees from GSK and Aerogen; personal fees from Novartis and TEVA; and grants from Therevance, outside the submitted work; they have patents related to acoustic measures to assess inhaler technique and methods to quantify adherence. R.A. Wise reports personal fees for consultancy from GlaxoSmithKline (GSK), during the conduct of the study; grants and personal fees for data monitoring committee work from AstraZeneca, Medimmune and Pearl; grants and personal fees for data monitoring committee and steering committee work from Boehringer Ingelheim; personal fees for steering committee work from Contrafect, Spiration, Kiniksa and Bristol Myers Squibb; personal fees for data monitoring committee work from Pulmonx, Roche, Merck, AbbVie and Kamada; personal fees for consultancy and workshops from Sunovion; grants from Pearl Therapeutics and Sanofi-Aventis; personal fees for consultancy from Circassia, Pneuma, Verona, Mylan/ Theravance, Propeller Health and Novartis; grants and personal fees for data monitoring committee work, advisory board work, steering committee work and consultancy from GSK, outside the submitted work. A. Ludwig-Sengpiel has nothing to disclose. G. Mosnaim reports grants and other fees (consultant/advisory board) from GlaxoSmithKline plc.; grants and other fees (consultant and/or member of a scientific advisory board) from Propeller Health and AstraZeneca; other fees (consultant and/or member of a scientific advisory board) from Sanofi-Regeneron, Teva, Novartis and Boehringer Ingelheim; grants and other fees from AstraZeneca, outside the submitted work; they own stock in Electrocore. J. Rees reports study funding and non-financial (writing) support from GlaxoSmithKline, during the conduct of the study; and is an employee of and holds shares/options in GlaxoSmithKline. R. Tomlinson reports study funding and non-financial (writing) support from GlaxoSmithKline, during the conduct of the study; and is an employee of and holds shares/options in GlaxoSmithKline. R. Tal-Singer reports study funding and non-financial (writing) support from GlaxoSmithKline, during the conduct of the study; and is a former employee of and holds shares/options in GlaxoSmithKline. D.A. Stempel reports study funding and non-financial (writing) support from GlaxoSmithKline, during the conduct of the study; is a former employee of and holds shares/options in GlaxoSmithKline; and is an employee of and holds shares/options in Propeller Health. N. Barnes reports study funding and non-financial (writing) support from GlaxoSmithKline, during the conduct of the study; and is an employee of and holds shares/options in GlaxoSmithKline.

Funding Information:
Support statement: This study (207040) was funded by GlaxoSmithKline R&D (NCT03380429). Funding information for this article has been deposited with the Crossref Funder Registry.

Funding Information:
Acknowledgements: The authors would like to thank the healthcare professionals (HCPs) at the participating study sites and the patients who took part in the study. They would also like to thank Bobbi Balogh (Propeller Health, Madison, WI, USA) for her project management support in the supply and use of the connected inhaler system (CIS). Editorial support was provided by Kate Hollingworth (Continuous Improvement Ltd) and funded by GlaxoSmithKline R&D.

Publisher Copyright:
© ERS 2021. This version is distributed under the terms of the Creative Commons Attribution NonCommercial Licence 4.0.

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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