As asthma treatment continues to improve with a shift toward personalized medicine, low treatment adherence remains an ongoing challenge in achieving optimal disease control in this patient population. Digital therapeutics (DTx) devices for asthma management may help to meet this challenge as well as other challenges related to asthma management, recent research suggests.

One such DTx intervention, the electronic monitoring device (EMD), can capture adherence data that is often inaccurately reported by patients. In a 2022 study of patient adherence to inhaled corticosteroid (ICS) asthma therapy, a large gap was found between patient-reported daily adherence and objective adherence data captured by EMDs for 41 children and 40 adults with persistent asthma. The median adherence rate over a 2-week period was self-reported by patients as 100% vs approximately 40% according to EMD data.1

The development of digital therapeutics (DTx) such as EMDs for use in asthma treatment has increased in recent years, especially since the COVID-19 pandemic began.2 Based on emerging research, these interventions represent a promising tool to improve adherence and other aspects of disease management in patients with asthma.

A March 2023 study in The Lancet Respiratory Medicine examined the value of using digital tools to track patient adherence and lung function in uncontrolled asthma, comparing treatment decisions made with vs without digital inhaler data as guidance. In a 32-week multicenter, single-blind, randomized clinical trial of 200 patients with asthma using digital inhalers, 102 patients were assigned to the “active group” — in which their clinicians actively used digital data on inhaler adherence and twice-daily digital measurements of peak expiratory flow to guide treatment adjustments, while 98 patients were assigned to a control group in which clinicians were not similarly guided by digital data.3

Digital inhaler systems can monitor a patient’s device use and provide useful information to providers. Digital inhalers can also be combined with a variety of other DTx tools, including asthma management platforms and telemedicine-related services, to individualize asthma care.

After adjustment for age, sex, baseline fractional inhaled nitric oxide (FeNO), and study site, analyses revealed the following results:

  • Fewer patients in the active vs control group (14% vs 32%, respectively) showed a net increase in treatment after 32 weeks or required add-on biological therapy (11% vs 21%, respectively).
  • Fewer patients in the active group vs the control group experienced a dosage increase from fluticasone propionate 500 μg daily to 1000 μg daily (16% vs 44%, respectively).
  • More patients in the active group vs control group experienced a dosage reduction of fluticasone propionate from 1000 μg daily to 500 μg daily (31% vs 18%, respectively). 
  • Higher mean adherence was seen in the active group vs control group from week 20 to week 32 (64.9% vs 55.5%, respectively).
  • Although the active group experienced more adverse events than the control group (55% vs 45%, respectively), none of these events were causally associated with the study intervention.3

“Evidence-based care informed by digital data led to a modest improvement in medication adherence and a significantly lower treatment burden,” the authors concluded.3

A meta-analysis published in March 2023 also reported favorable results with the use of EMDs to monitor adherence in adult patients with asthma and those with chronic obstructive pulmonary disease.4

For more insight into the current and future role of DTx in asthma management, Pulmonology Advisor interviewed:

  • Richard Costello, MD, professor of respiratory medicine at the Royal College of Surgeons in Ireland University of Medicine and Health Science in Dublin, chair of education at the European Respiratory Society, and investigator in the 2023 trial reported in The Lancet Respiratory Medicine3;
  • Muhammad Adrish, MD, MBA, associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine at Houston, Texas, and chair of the Airways Disorders Network at the American College of Chest Physicians; and
  • Giselle S. Mosnaim, MD, MS, clinical associate professor of allergy and immunology at the Pritzker School of Medicine at the University of Chicago in Illinois and first author of a 2022 paper that aims to guide clinicians and health care systems in the adoption and use of digital inhalers and remote monitoring for patients with asthma.5

What types of DTx are currently available for asthma management, and how would they fit into a broader treatment plan? 

Dr Costello: The digital interventions that have been developed to date are interventions to support patient self-management, including devices that attach to inhalers and assess inhaler use and, in some cases, inhaler technique. There are also some devices that assess lung function, digital spirometers, digital peak flow, and oscillometry, all of which can be used in self-management as well.6 

Dr Adrish: Self-management is an effective tool to optimize asthma control, and DTx can be used in several areas of self-management. These tools have the potential to address gaps in patient care, help patients manage their disease, and improve health-related outcomes. Telemedicine, digital questionnaires, interactive and noninteractive educational platforms, automated reminders, and remote monitoring including wearable technologies have not only increased patient access to providers but have also provided additional tools to optimize asthma care.

Digital inhaler systems can monitor a patient’s device use and provide useful information to providers. Digital inhalers can also be combined with a variety of other DTx tools, including asthma management platforms and telemedicine-related services, to individualize asthma care.

Dr Mosnaim: DTx generally are divided into 2 categories: electronic medication monitors and digital inhaler systems. Electronic medication monitors consist of a sensor that records the date and time of inhaled medication actuation. These can be built into the inhaler device or attached onto the inhaler. The sensors then transmit this data to a paired app on the patient’s phone.

The patient can track their adherence to daily ICS-containing medications as well as their use of as-needed rescue medications. When patients notice they are needing to use their rescue medication more often, this may signal an impending asthma exacerbation and alert them to refer to their asthma action plan or contact their health care professional for further recommendations.

The digital inhaler systems include all of the electronic medication monitor components plus a secure health care professional dashboard. The clinician can monitor a patient’s usage of controller and reliever medications on the dashboard in real time, and they can call the patient or ask them to come in for an urgent visit if they observe a lack of controller usage or overreliance on rescue medication.

What outcomes are these devices designed to improve, and how effective are they in improving these outcomes?

Dr Costello: These [devices] are individually useful in supporting self-management, and in our recent clinical trial, we showed that these devices can be used as clinician support tools.3 Using these devices in combination with evidence-based care, we showed that clinicians were far less likely to add medication in patients with uncontrolled asthma. The data allowed them to distinguish between difficult-to-control asthma and severe asthma, and these insights led to safer prescribing. This was an important finding, as it was the first to show the clinical value of these devices for all partners in health care — patients, providers, and payers.

Dr Adrish: Telemedicine tools improve patient access to providers.7 Digital questionnaires and educational platforms are designed to improve disease understanding, awareness of signs and symptoms of asthma control, and self-management.8 Smart inhaler systems help providers obtain real-time data on medication-taking behavior of patient, and they can incorporate that data into their feedback.5 Studies have also shown that wearable technologies and remote monitoring tools can identify patients at risk of exacerbation and hospitalization.9

Dr Mosnaim: These devices are effective at improving adherence to asthma controller medications and thus decrease the use of rescue medications, whose overuse can signal an impending asthma flare. The devices have also demonstrated improvements in asthma control.

Based on your knowledge and experience, what are clinician and patient attitudes towards asthma DTx? 

Dr Costello: There is an emerging body of work to suggest that these devices are well-regarded by patients. Dr Amy Chan6 in New Zealand has done a lot of work in this area.

Dr Adrish: Pandemic lockdowns have fueled the rise of telemedicine and DTx technologies. There is a growing list of medical conditions in which DTx are being used with the aim of personalizing care by providing patients and providers real-time data on the disease state, and to improve access, efficiency, cost, and quality of care. While many of these technologies have support from clinical studies, there are several challenges to wider adoption, including provider acceptance, cost of interventions, insurance coverage, management of large data, privacy concerns, and technology literacy.10 Addressing these challenges could improve patient access to DTx.

Dr Mosnaim: Health care professionals and patients are excited about using DTx. However, a barrier for patients is the ability to afford these devices or have them covered by their insurance. A challenge for clinicians is deciding how to integrate their use into patient care workflows. Based on the progress we are making in our practice, I am optimistic that both of these challenges will be resolved.

What kinds of DTx are currently in development for asthma, and what do you see as the future of DTx for asthma and possibly other pulmonary conditions?

Dr Costello: I can see the potential for devices to assess respiratory failure, detect and monitor exacerbations, and diagnose and distinguish the cause of breathlessness.

Dr Adrish: In this era of increased access to the digital environment, the role of DTx in managing pulmonary conditions including asthma will continue to evolve. Like any other technology-driven industry, DTx may also face similar challenges in infrastructure, development, dissemination, and technology adoption.

Ease of use, customizability, and accessibility will likely remain central to the long-term adoption of any technology. As we look to the future of DTx in asthma, adoption of these therapeutics continues to move in the right direction.

Last year, CMS [US Centers for Medicare and Medicaid Services] implemented a code for prescription digital therapy, which will likely improve coverage by Medicaid and commercial plans.11 Earlier this year, the Access to Prescription Digital Therapeutics Act of 2023 was introduced by a bipartisan group of legislators with goal to expand Medicare coverage for digital treatments.12 While there is still a long way to go, I believe we are getting close to a wider adoption of DTx every passing day.

With increasing momentum in DTx, there is a need for robust regulatory oversight to ensure that the marketed tools have the data to support their clinical use. There is also a need for more real-world data to ensure that the benefits of DTx tools can also be replicated outside the controlled environment of a clinical study.

Dr Mosnaim: Some currently available digital inhaler systems can now track both medication usage and inhalation quality. Inhalation quality is very important because studies show that many patients do not use their inhalers correctly, and this is associated with worse asthma outcomes. Receiving feedback on inhalation quality on their asthma app can help patients to improve their technique. This can also help clinicians to focus on inhaler teaching on asthma follow-up visits. It is important for patients and health care professionals to review medication adherence and inhaler technique before increasing the dose of medications, thus reducing medication side effects and costs.

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