PHOENIX — Before considering oral steroids or biologic therapies, many people with difficult-to-control asthma can reduce symptoms by addressing medication adherence and inhaler technique — and digital monitoring devices can play a key role.
Dr William Anderson
Often physicians “will approach a patient about a biologic if they’re not responding to standard therapy. But we need to sometimes go back to those basic building blocks, like, are you taking the standard therapy?” said William C. Anderson, MD, co-director of the multidisciplinary asthma clinic at Children’s Hospital Colorado, in an interview with Medscape Medical News.
At the American Academy of Allergy, Asthma and Immunology annual meeting held February 25-28, he and others presented data highlighting the diagnostic and therapeutic potential of digital monitoring devices for difficult-to-control asthma, the theme of this year’s meeting.
The Global Initiative for Asthma (GINA) defines asthma as “difficult to control” if it remains uncontrolled despite medium- or high-dose inhaled corticosteroids with a second controller or with maintenance oral steroids, or if the asthma requires high-dose treatment to curb symptoms and exacerbations. Seventeen percent of adult asthma patients have difficult-to-control asthma, according to the 2021 GINA report.
However, correcting for inhaling technique and adherence cuts the 17% down to just 3.7%, Giselle Mosnaim, MD, an allergist at NorthShore University HealthSystem outside Chicago and AAAAI immediate past president, told attendees at a February 25 session on digital technologies for asthma management.
Dr Giselle Mosnaim
The CRITIKAL study, which reviewed data from more than 5000 asthma patients, “showed that if you have critical errors in inhaler technique, this leads to worse asthma outcomes and increased asthma exacerbations,” Mosnaim said. Sadly, it also shows that from 1975 to 2014, despite new devices and new technologies, “we still have poor inhaler technique.”
As for ways to measure adherence, physician judgments tend to be inaccurate, patient self- reporting has proved unreliable, and prescription refill data doesn’t indicate whether patients actually used the medications. “The ideal measure of adherence should be objective, accurate and unobtrusive to minimize impact on patient behavior and allow reliable data collection in real-world settings,” Mosnaim said. “So electronic medication monitors are the gold standard.”
A closing afternoon session featured three presentations on research tracking adherence and outcomes in difficult-to-treat asthma patients — two pediatric cohorts and one across all ages. All studies used the Propeller Health sensor, an FDA-cleared device that attaches to the patient’s inhaler and automatically collects information on where, when, and how often they use their medication. The sensor then sends that information to a data cloud accessible to the patient and their healthcare professional.
Anderson’s team scoured a nationwide Propeller Health database for 8000 patients using the digital monitors with controller therapies for asthma or chronic obstructive pulmonary disease (COPD). The study explored whether adherence differed for once-daily vs twice-daily medications, and if adherence differed based on patient age (4-60+ years).
For both asthma and COPD patients, those on once-daily regimens had higher medication adherence compared to those who were prescribed twice-daily therapies. Plus, a greater proportion of once-daily patients met the prespecified 80% adherence threshold.
Looking across ages, medication use in the youngest group (aged 4-11 years) looked comparable to thirty-somethings, “probably because parents are the ones giving the drug,” Anderson said. Mirroring patterns from other studies, adherence levels dipped in adolescents and young adults, relative to other age subsets.
Since this population-level analysis didn’t include individualized data on exacerbations or asthma control, “we can’t relate this to outcomes,” Anderson noted. But he said the data correlating medication use with adherence suggest that once-daily formulations may be the better option.
Dr Matt McCulloch
In one of the two pediatric studies, Matt McCulloch, MD, an allergy and immunology fellow working with Anderson, and colleagues reviewed charts of 40 children who received care at the Colorado Children’s multidisciplinary asthma clinic between 2018 and 2021. Half of these patients used Propeller Health sensors with their daily inhaled controller; the other patients were matched for age, ethnicity, sex, medication level, and disease control and severity — but had no electronic monitoring device.
On the whole, children who used digital monitoring for 12 months did not fare much better than matched controls on lung function (judged by forced expiratory volume, or FEV1%) or asthma control (measured by Asthma Control Test [ACT] scores).
However, within the digital monitoring group, patients who stayed on the Propeller system for 12 months did have better asthma control, fewer exacerbations, and improved asthma severity scores (measured by the Composite Asthma Severity Index) — compared with when they first began digital monitoring. These children had all received care at the clinic for a while before their families opted for the electronic sensor, so “the effect wouldn’t have just been from starting in the clinic,” McCulloch told Medscape.
The gains came despite waning medication adherence. Similar to other digital monitoring studies, use of daily controller therapies in this retrospective analysis began at 50%-80% but dropped considerably during the first 4-5 months before settling into the 20%-30% range by 1 year.
Dr Rachelle Ramsey
Rachelle Ramsey, PhD, a pediatric research psychologist at Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, presented data from 20 children with difficult-to-treat asthma who received 8 weeks of a digital adherence intervention during a 12-month treatment period. They analyzed three subsets — each with interventions based on how well the patients were managing daily controller therapy at baseline.
One patient with high (>80%) baseline adherence just received digital monitoring. The seven patients who began the study with intermediate (50%–80%) adherence received digital monitoring plus prescriptive text messaging. And the 12 children with poorest (<50%) baseline adherence received digital monitoring and a telehealth session in which a behavioral health specialist helped them set goals and create strategies to overcome barriers — for example, keeping the inhaler near their toothbrush in order to pair medication use with a daily habit.
“Overall, we found that matching Propeller with a behavioral intervention really improved adherence,” Ramsey told Medscape. While patients were receiving the intervention, adherence averaged across all groups increased from 39% to 76%. However, once the intervention period ended, the group’s adherence regressed toward baseline (36%).
Although adherence did not associate with clinical gains in this small study, the use of digital monitoring to improve medication adherence has translated to better outcomes in other recent efforts.
In a quality improvement project in the United Kingdom, nurses asked difficult-to-control asthma patients if they understood how to use their corticosteroid/long-acting beta2-agonist (LABA) inhalers and if they were adhering to treatment guidelines.
Those who answered yes to these questions were invited to a 28-day study that involved swapping their steroid/LABA inhalers for a different controller/bronchodilator (fluticasone/salmeterol) with INCA, a device that not only tracks adherence but also uses acoustics to gauge inhaler technique. INCA stands for Inhaler Compliance Assessment.
Among the 23 patients who participated, many had better clinical outcomes after 28 days of INCA monitoring. As Mosnaim told attendees, “What was amazing is so many of the patients that had been these difficult-to-control asthmatics who would have gone on to oral steroids or perhaps a biologic—lo and behold, you put them on a digital inhaler, and what do you see?” In two-thirds of the patients, “you see FeNo [a test that measures airway inflammation by detecting nitric oxide in exhalations] goes down. You see spirometry improve. You see the asthma control questionnaire improve. You see blood eosinophils go down.”
And in a 2020 randomized trial, Mosnaim and colleagues recruited 100 adults with uncontrolled asthma who had prescriptions for a daily inhaled corticosteroid and a short-acting beta agonist (SABA) inhaler. Participants received Propeller sensors for their steroid and SABA inhalers. After a 2-week run-in period to calculate baseline corticosteroid adherence and SABA use for all participants, half the participants were randomly assigned to the control group, which had the app and sensor in silent mode, merely to collect data on medication use — whereas the treatment group received reminders, alerts, and monthly phone calls from providers who gave feedback on adherence and technique.
After 3 months of digital monitoring, patients didn’t use their rescue medication quite as often — as judged by a rise in the percentage of SABA-free days compared with when they began the study. But the change in SABA-free days relative to baseline was more pronounced in the treatment group (19%) than in the control group (6%).
As seen in the other digital monitoring studies, adherence to daily corticosteroids fell with time, but the drop was milder in treated participants (2%) vs the control group (17%). So in this study, digital monitoring plus mobile app reminders and clinician feedback “prevented against fall in adherence to inhaled steroids over time,” Mosnaim said.
Dr Thanai Pongdee
These results are “very encouraging” and offer “proof of concept that this type of remote monitoring could work,” said Thanai Pongdee, MD, an allergist-immunologist with the Mayo Clinic in Rochester, Minnesota, in an interview with Medscape. One limitation was that the study was too short to measure exacerbation rates, he noted. A yearlong analysis would be “really fascinating because you’d catch all the seasons of the year — all the pollen seasons, all these things that could exacerbate you,” he said. “Some people’s asthma can be quite seasonal.”
More important, the clinical utility of digital sensors will depend on how physicians choose to use them. If the doctor puts out a “blanket recommendation for using it but doesn’t ask you about it or doesn’t use the data to inform your care, then I think people just lose engagement and lose excitement over it,” Ramsey said. But if the healthcare team “asks you about the data or looks at the data with you or shows you how valuable this can be to your care, then I think that changes things.”
Building these analyses and interactions into the clinic workflow isn’t trivial. “If you have this wealth of data coming in, how are you going to look at it? Are you going to have an individual person assigned to this role? How are you going to respond to alerts?” Anderson asked.
In addition, because some digital monitors issue alerts when a patient’s asthma is not well controlled, some providers worry about liability if “something bad were to happen if you had that data but didn’t act upon it,” he said. Yet he notes that remote data monitoring is already used routinely in other areas of medicine, such as managing diabetes and heart conditions, “and it’s not like people are getting dinged for that stuff.”
Another issue is cost. Insurance only covers digital monitors in select cases, but it’s a bit of a catch-22. Insurers “don’t want to cover it until they get the data, but you can’t get the data until insurance covers it,” said Anderson, who added that “this year we finally got CPT reimbursement codes for monitoring devices.”
On the whole, studies of digital medication monitors suggest that better outcomes require “a good partnership between the healthcare provider and the patient,” Pongdee said. “It wasn’t like you could just put these things on and expect them to help. You still need that personal relationship to get the optimal results. We can have all this technology, but you still can’t take the people out of it.”
Mosnaim reports current research grant support from GlaxoSmithKline, Novartis, Sanofi-Regeneron and Teva; and past research grant support from AstraZeneca, Alk-Abello and Genentech. She is immediate past president of the American Academy of Allergy, Asthma and Immunology, and directs the board of directors for the American Board of Allergy and Immunology. Anderson has served as a consultant for Regeneron, GlaxoSmithKline, and AstraZeneca, and has received research support from CO Medicaid.
McCulloch and Ramsey have disclosed no relevant financial relationships. Pongdee serves as an at-large director on the American Academy of Allergy, Asthma and Immunology board of directors. He receives grant funding from GlaxoSmithKline, and Mayo Clinic is a trial site for GlaxoSmithKline and AstraZeneca.
American Academy of Allergy, Asthma and Immunology (2022) Annual Meeting. Presented February 25-28, 2022.
Esther Landhuis is a freelance science journalist in the San Francisco Bay Area. She can be found on Twitter @elandhuis.