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

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.

Improving adherence in chronic airways disease: are we doing it wrongly?

“…These results are in contrast to a recent study by M oore et al [ 73 ] investigating the effect a clip-on inhaler sensor, a patient-facing app and HCP dashboard. They found that despite a statistically significant increase in ICS adherence of 12% in the Ellipta-monitored arm, there was no significant difference between groups after 6 months using the ACT score [ 74 ].…”

“…In summary, these studies suggest that adherence may improve with individualised selfmanagement education programmes, by feeding back on inhaler deviations and by providing free prescriptions to those who would otherwise pay, but there is limited evidence to support interventions reminding patients (or their parents) to collect or administer medication, for redesigned services that patients do not engage with or that usurp Improving adherence in chronic airways disease patient/parent responsibility in medicines use. The waning adherence seen over even short periods of time suggests that interventions require regular refreshing to maintain impact [52,55,56,73].…”

“…Somewhat surprisingly, common themes in adherence are that its improvement does not consistently result in a corresponding improvement in biomarkers, morbidity, mortality, quality of life, patient satisfaction, healthcare use, or costs [73,[75][76][77][78], that symptoms do not beget adherence [79] and the effectiveness of seemingly similar treatments may be affected differently by concomitant treatment adherence [80,81]. A 2017 Cochrane review aimed to assess the efficacy and safety of interventions intended to improve adherence to ICS therapy in asthma [75].…”

Measuring adherence to therapy in airways disease

“…It has previously been shown that a patient's capability in managing their disease can be improved by involving them in the process of monitoring their symptoms [ 61 ]. A recent study, conducted in patients with uncontrolled asthma [ 62 ], showed that a patient group who were provided a CIS which provided feedback on maintenance inhaler use to both patients and healthcare professionals (HCPs) had significantly higher adherence rates versus a control group where no electronic sensors were provided. This study also compared the control group with the use of a CIS in three other groups that provided data on: 1) maintenance inhaler feedback to participants only; 2) maintenance and reliever inhaler feedback to patients and HCPs; and 3) the maintenance and reliever inhaler feedback to patients only.…”

Maximizing Adherence and Gaining New Information For Your Chronic Obstructive Pulmonary Disease (MAGNIFY COPD): Study Protocol for the Pragmatic, Cluster Randomized Trial Evaluating the Impact of Dual Bronchodilator with Add-On Sensor and Electronic Monitoring on Clinical Outcomes

“… 19 , 20 Recently, a connected inhaler system (comprising clip-on inhaler sensors, a patient-facing app, and a healthcare professional dashboard) was shown to improve adherence to maintenance therapy in patients with respiratory disease; however, such system did not show an improvement in clinical outcomes, possibly due to high adherence in the control arm. 21 This suggests the need for studies where the control arm is maintained as usual care.…”