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.
Footnotes
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Conflict of interest: Dr. Moore reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Preece reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Sharma reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Mosnaim reports grants and other from GlaxoSmithKline plc., grants and other from Propeller Health, other from Electrocore, other from Sanofi-Regeneron, Teva, Novartis, Boehringer Ingelheim, grants and other from AstraZeneca, outside the submitted work.
Conflict of interest: RWC has patents related to the acoustic measures to assess inhaler technique and methods to quantify adherence.
Conflict of interest: Dr. Wise reports personal fees from GlaxoSmithKline (GSK), during the conduct of the study; grants and personal fees from AstraZeneca / Medimmune / Pearl, grants and personal fees from Boehringer Ingelheim, personal fees from Contrafect, personal fees from Pulmonx, personal fees from Roche, personal fees from Spiration, personal fees from Sunovion, grants from Pearl Therapeutics, personal fees from Merck, personal fees from Circassia, grants and personal fees from GSK, personal fees from Pneuma, personal fees from Verona, personal fees from Mylan/Theravance, personal fees from Propeller Health, grants from Sanofi-Aventis, personal fees from AbbVie, personal fees from GSK, personal fees from Novartis, personal fees from Kamada, personal fees from Kiniksa, personal fees from Bristol Myers, outside the submitted work.
Conflict of interest: Dr. Ludwig-Sengpiel has nothing to disclose.
Conflict of interest: Dr. Heaney reports non-financial support from GlaxoSmithKline, from null, during the conduct of the study; grants from Amgen, AstraZeneca, Medimmune, Janssen, Novartis, Roche / Genentech, GlaxoSmithKline plc., Boehringer Ingelheim, Aerocrine and Vitalograph, other from Novartis, Hoffman la Roche/Genentech Inc, Evelo Biosciences, Sanofi, Glaxo Smith Kline, Astra Zeneca, Teva, Theravance, Circassia, other from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK and Napp Pharmaceutical, other from Medimmune, Novartis UK, Roche / Genentech, and GlaxoSmithKline plc., from Astra Zeneca, GlaxoSmithKline, Schering Plough, Synairgen, Novartis, and Roche / Genentech) , outside the submitted work.
Conflict of interest: Mr. Rees reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Tomlinson reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Stempel reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, from Propeller Health, from Propeller Health, outside the submitted work.
Conflict of interest: Dr. Barnes reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Tal Singer reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
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- Received August 11, 2020.
- Accepted November 19, 2020.
- Copyright ©ERS 2020
