FormalPara Key Summary Points

Asthma is a significant global health problem with a prevalence of approximately 6% in Germany. Despite advances in inhalation therapy, more than half of the patients report their asthma to be poorly controlled. This may be due to poor adherence to inhaled therapy or improper inhalation technique.

Digital self-management inhaler devices that record medication use and provide reminders may improve treatment adherence and asthma treatment outcomes.

This novel analysis assesses the effect of indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF) Breezhaler digital companion (sensor + smartphone application) on medication adherence and symptom control in adults with asthma from Germany.

Through a comprehensive retrospective assessment of data over a period of 90 days, we demonstrated ≥ 80% medication adherence in over 70% of patients, along with substantial improvements in the Asthma Control Test (ACT) scores, indicating an improvement in symptom control.

These data provide positive evidence on the potential use of digital companion paired inhaler devices in improving asthma control.

Introduction

Asthma affects approximately 6% of adults in Germany [1]. Despite advances in inhalation therapies, more than half of the patients report poorly controlled asthma [2]. Uncontrolled asthma may, in part, be attributed to suboptimal adherence to controller medications [3] and/or inadequate inhalation techniques [4].

The documentation of controller medication adherence commonly relies on patient self-reporting, which may overstate the use due to reporting bias or pharmacy claims data which documents the medication dispensed, but not its usage [4]. Valid adherence data is needed to assess the effectiveness of treatment plans. This analysis retrospectively assessed data from a quality improvement program which included a digital self-management intervention to improve medication adherence and asthma symptom control among adults with asthma living in Germany.

Methods

This is a retrospective analysis of data collected from a digital companion as part of a quality improvement program for adults with asthma. While invitation to participate in this program was based on the physician’s discretion, eligible patients needed to be at least 18 years of age, reside in Germany and be prescribed the indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF) Breezhaler® with the digital companion (Propeller Health, Wisconsin, USA), which included medication sensors to record the date and time of inhaler usage.

Data collected from the sensor was then wirelessly transmitted via Bluetooth to a paired smartphone application that provided patients with feedback on their medication use and sent medication reminders if a controller dose was not taken within 15 min of the stated medication schedule. Although requested, but not required, the app also prompted patients to complete the Asthma Control Test (ACT), a questionnaire to assess symptom control, at baseline and at monthly intervals.

Controller medication adherence was measured during month 1 (days 16–30) and month 3 (days 76–90) using data from the sensor. Daily medication adherence was determined by the number of doses taken divided by the number of doses prescribed × 100. The proportion of patients achieving ≥ 80% adherence was then examined by age group. The threshold of ≥ 80% was selected as the target endpoint based on previous literature [5, 6]. The percent of patients with ≥ 80% medication adherence between days 16–30 and 76–90, and the change in ACT from baseline and first available ACT at ≥ 30 days, was then examined using McNemar’s test. In addition, the comparison by age (< 40 versus ≥ 40 years) of the percent of patients who achieved target adherence at month 3 was examined as an exploratory analysis using Fisher’s exact test.

This manuscript describes a retrospective analysis of data previously collected as part of a quality improvement program which included post marketed data from devices previously prescribed by physicians. The program was conducted in accordance with the Declaration of Helsinki and the patients provided consent for the retrospective analysis of data collected as part of a quality improvement program. An IRB approval was not sought, as the criteria for IRB submission and approval necessitate that the analysis involves direct interaction with a human subject or access to identifiable private information, neither of which occurred during our program. All data was de-identified prior to analyses. All participants agreed to Propeller’s terms of use which describes the use of de-identified data for research purposes.

Results

A total of 163 patients with 90 days of data were included in the analysis. Patients had a mean [standard deviation (SD)] age of 49 (± 15) years; 27% were ≥ 60 years of age. The mean (SD) baseline ACT was 16.7 (± 4.9). The target adherence of ≥ 80% medication was achieved by 82.8% of patients during month 1 and 72.4% of patients at 3 months (Fig. 1i). More patients ≥ 40 years of age achieved target adherence at month 3 compared with those who were < 40 years (78% versus 56%, P = 0.0017, respectively).

Fig. 1
figure 1

(i) Change in the percent of patients with ≥ 80% adherence from days 16–30 to days 76–90 by all ages and by age subgroups, and (ii) change in the percent of patients with ACT ≥ 20 from baseline to second test by all ages and age subgroups

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Change in asthma control was examined in patients who had completed at least two ACTs through the application. Ninety-seven patients (~ 60%) who completed the assessment on the application were included for the analysis of change in asthma control. At baseline, 33% of patients were well controlled which increased to 53.6% at second ACT (Δ = 20.6%, P = 0.171, Fig. 1ii). Furthermore, 43.3% of patients had very poor control at baseline; this decreased to 22.7% at second ACT (Δ =  − 20.6%; P = 0.003).

Discussion

The Global Initiative for Asthma (GINA) describes the primary goal of asthma management as attaining ‘good control of symptoms and maintaining normal activity levels [7]’. The present analysis demonstrated that over 70% of patients achieved and maintained high levels of medication adherence (≥ 80%) with the combination of IND/GLY/MF Breezhaler and its digital companion. Parallel improvements in monthly ACT scores were observed. These findings suggest that maintaining high medication adherence may support improved asthma control.

The 80% threshold was selected on the basis of the literature [5, 6] and statistics, which show that adherence data are not normally distributed. Mean adherence is a common reporting metric employed to analyse patterns of medication use, but may reflect low- or non-users (< 20% medication adherence). Patients with low baseline adherence may be more recalcitrant to the intervention [8]. Digital technology identifies this challenging population as requiring a more intensive and personalised intervention.

This analysis may be limited due to its observational nature and lack of a control arm. Data on patient gender, socioeconomic status, race, disease severity, and previous history of medications, including inhaled corticosteroids use, were not available. Further, we did not have information on the use of short-acting beta agonists, oral corticosteroids, or healthcare utilisation (e.g., emergency room or hospital visits) before or during the assessment period. These types of information may have helped give further context to the results observed and should be explored in future studies. This analysis also reports on adherence in a single country, thus limiting the generalisability to other countries where asthma management may differ. Finally, this analysis used a self-reported measure to determine asthma control – additional studies are needed to confirm results with more objective measures, e.g. short-acting beta-agonist use, or spirometry and peak flow measurements, which may provide a more objective classification of disease status. Despite these limitations, this quality improvement program is indicative of the success of improved asthma control, as measured by the Asthma Control Test, with IND/GLY/MF Breezhaler and its digital companion.

Conclusion

Achieving a high level of controller medication adherence is an important aspect of asthma self-management that supports improved asthma control. Although high levels of adherence are the desired outcome, identifying patients with poor adherence should alert health care providers about patients needing further assessments and intervention. Considering this program’s limitations, further long-term studies are needed to confirm the findings and to evaluate the factors that influence medication adherence in patients with asthma.