Abstract
Introduction
Suboptimal adherence to inhaled asthma therapy is associated with poor clinical outcomes. Digital companion paired inhaler devices record medication use and provide reminders, thereby improving treatment adherence and asthma outcomes. This analysis assessed the impact of indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF) Breezhaler® digital companion on medication adherence and symptom control in adults with asthma from Germany.
Methods
This retrospective analysis included adults (≥ 18 years) with asthma and prescribed Breezhaler digital companion. Assessments included: mean medication adherence (number of puffs taken/prescribed × 100) and change in Asthma Control Test (ACT) scores [well controlled (≥ 20), not well controlled (15–20) and poorly controlled (≤ 15)] at 1 month after the first ACT (second ACT). The percent of patients with ≥ 80% medication adherence (days 16–30 and 76–90) and the change in ACT (baseline and ≥ 30 days) were analysed.
Results
Of the 163 patients with 90 days data, ≥ 80% medication adherence was achieved in 82.8% and 72.4% of patients at months 1 and 3, respectively. Change in asthma control was examined in ~ 60% (n = 97) of patients who completed ≥ 2 ACTs through the application. At baseline, 33.0% of patients were well controlled and 53.6% were well controlled at second ACT. Furthermore, 43.3% patients reported very poor control at baseline which decreased to 22.7% at second ACT.
Conclusion
The use of IND/GLY/MF (Breezhaler) with a digital companion (sensor + application) may be associated with improved symptom control and high level of controller medication adherence in patients with asthma.
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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).
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.
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Acknowledgements
We thank the investigators and patients at the investigative sites for their support during the conduct of the study.
Funding
The study and the journal's Rapid Service Fee was funded by Novartis Pharmaceuticals Corporation, East Hanover, USA; ResMed Science Center, San Diego, USA and Propeller Health, Madison, WI, USA.
Medical Writing and Editorial Assistance
Under the direction of authors, Anupama Boddupalli, Jogindersingh Paneysar and Asma S (Novartis Healthcare Pvt. Ltd. India) provided editorial support, in accordance with Good Publication Practice (GPP2022) guidelines (https://www.ismpp.org/gpp-2022).
Author Contributions
The study was designed and conducted by Paul Mastoridis, Karen Mezzi, David Stempel, Leanne Kaye and Vy Vuong. Data were acquired and analysed by Vy Vuong. All authors contributed equally to the interpretation of data. Holger Woehrle is the principal investigator for this study. All authors contributed to intellectual content of the manuscript and approved for publication.
Disclosures
Holger Woehrle reports grants/research support from Novartis and ResMed, honoraria or consultation fees from Astra Zeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, ResMed and Sanofi and is the head of the working group on digitisation of the German Board of Pulmonologists, and co-chair of the sleep medicine group of the German Respiratory Society. David Stempel is a former employee of Propeller Health. Vy Vuong and Leanne Kaye are employees of ResMed, the parent company of Propeller Health. Karen Mezzi and Paul Mastoridis are employees of Novartis.
Compliance with Ethics Guidelines
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 taken, 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.
Data Availability
Novartis is committed to sharing access to patient-level data and supporting documents from eligible studies with qualified external researchers. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymised to respect the privacy of patients who have participated in the trial, in line with applicable laws and regulations.
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Woehrle, H., Mastoridis, P., Stempel, D. et al. Medication Adherence and Asthma Control with Once-Daily Indacaterol/Glycopyrronium/Mometasone Furoate Breezhaler Digital Companion: 90-Day Analysis from Germany. Pulm Ther 9, 429–434 (2023). https://doi.org/10.1007/s41030-023-00225-z
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DOI: https://doi.org/10.1007/s41030-023-00225-z