Asthma control may improve with electronic inhaler use
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Key takeaways:
- The Digihaler records data on inhaler usage and inhalation quality, which is then shared with the patient through an app and with the health care provider through a dashboard.
- 61% of patients who used the Digihaler achieved well-controlled asthma or experienced improvements in asthma control, compared with 55% of patients who used the standard of care.
- Digihaler users also experienced reductions in short-acting beta 2 agonist (SABA) use, increases in the weekly number of SABA-free days and more discussions with their health care provider about inhaler technique.
Patients who used the Reliever Digihaler System had better odds for improved asthma control compared with patients using the standard of care, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice.
These patients also less frequently used short-acting beta 2 agonists (SABA) and experienced more SABA-free days, Flavia Cecilia Lega Hoyte, MD, allergist and immunologist at National Jewish Health, and colleagues wrote.
The Reliever Digihaler System (RDS) includes the ProAir Digihaler (Teva Pharmaceuticals), a patient-facing smart device application and a secure, web-based health care professional-facing dashboard.
Approved by the FDA, the Digihaler is an electronic multidose breath-actuated dry powder albuterol inhaler that records quantity and timing of usage, peak inspiratory flow, inhalation volume, inhalation duration and time to peak inspiratory flow.
A sensor inside the Digihaler transmits this data via Bluetooth to the application, which reports on the quality of the inhalation, stores data and produces user reports that health care providers can review via the dashboard.
The CONNECT1 study included 333 patients aged 13 years and older (mean age, 43.7 years; 69% female) with asthma randomly assigned to RDS (n = 167) standard of care (SoC; n = 166), which included albuterol reliever inhalers.
The timeline included a screening visit, during which all patients took the Asthma Control Test (ACT) and patients in the RDS group received two Digihaler devices and were taught how to use the inhaler and the app; 12 weeks of treatment; and a follow-up call 2 weeks after treatment completion.
By week 12, 61% of the RDS group and 55% of the SoC group achieved well-controlled asthma, defined as an ACT score of 20 or higher, or an improvement in asthma control, defined as an increase in ACT score of 3 or more.
According to the researchers, these results translate to an 85.3% probability that RDS users would have greater odds of achieving improved asthma control after 3 months compared with SoC users. Also, the RDS vs. SoC users had 33% higher odds for achieving meaningful improvement.
Although RDS and SoC users had similar numbers of interactions with health care personnel such as office visits and phone calls (239 vs. 222), the RDS group had 52 interactions due to poor inhaler technique, whereas the SoC group had one.
Further, 85 of the RDS group’s interactions were due to information gleaned from the dashboard, including 32 (37.6%) due to increased SABA use.
During these interactions, the RDS users had more discussions about inhaler use with their health care providers than the SoC group, including inhaler technique (87 vs. 34), adherence (71 vs. 42) and both technique and adherence (46 vs. 32).
From week 1 to week 12, the RDS group had more SABA-free days (3.4 vs. 4.6) and a decrease in average daily SABA inhalations (9.1 vs. 6.3).
Plus, the RDS group rated the usability and acceptability of the application and the sites related to the dashboard as “good.”
Both groups had similar numbers of patients who experienced one or more adverse events during the study period (RDS, 28; SoC, 26), with no events related to the device or leading to discontinuation.
Finally, the Digihalers consistently categorized 87% or more of all inhalations each week as “good” or “fair” throughout the study period with no evidence of deterioration in technique.
Based on these results, the researchers concluded that the RDS group experienced improved asthma control. While this study examined reliever inhaler usage, the researchers wrote, the CONNECT2 study will explore RDS use for maintenance inhalers.
Perspective
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Although these results are not surprising, the emphasis on the importance of digital health cannot be underestimated. In my opinion, this study demonstrates that the use of this technology improves inhaler technique.
However, I cannot conclude with confidence that RDS improves asthma control, as reported by the authors. Although the probability of significant clinical response with RDS was found to be 0.85 (or 85%), there is also a significant placebo effect, and the mean odds ratio for RDS/SoC was 1.33 (95% CI, 0.813-2.05). The confidence interval crossing 1 suggests that the findings are not statistically significant.
As clinicians, we tie asthma control to controller medication — inhaled corticosteroids in particular — which makes it tricky to understand the association between control and rescue inhaler use. It makes sense, as reported in the case, that by improving inhaler technique, one can increase the dose of medications delivered to the patient. Hence, patients might notice improved asthma control and less rescue inhaler use.
The fact that this study is an open-label study raises concern about the effect of patient-health care provider interaction and the effect of such interaction on asthma management optimization. Said differently, bias can be introduced by the fact that asthma management was left to the judgement of the investigator in this open-label study.
At the end of the day, whether digital health improves outcomes in asthma by improving inhaler technique or increases the identification of sub-optimally treated individuals is not important. Either way, it seems like a win-win situation. However, due to the limitations of this study, I would like to see these results replicated in a future study with a better methodology.
Also, I concur with the authors that one of the biggest challenges with asthma is education about inhaler technique and adherence to therapy, a fact that is frequently confounded by access to medication prohibited by the inhaler’s price tag.
I definitely see the advantage of digital health and the feedback it provides, which will lead to improved inhaler technique and increased interactions with the health care provider. This is especially important for patients with severe uncontrolled asthma who might benefit from additional education, referral to an asthma center and medication adjustment.
To improve the quality of the care that they provide, physicians can follow trends in rescue inhaler use to identify patients at risk for uncontrolled asthma, including asthma exacerbations and health care utilization. Here, an early intervention such as asthma education and escalation of therapy according to Global Initiative for Asthma guidelines might make a noticeable difference in asthma outcomes and control. However, this technology may add increased strain to a health care system stretched too thin, especially now with the nursing shortage.
Finally, data safety is always a concern whenever personal information is exchanged. Hence, a thorough investigation of the safety measures including updates, upgrades and maintenance implemented to maintain patient confidentiality becomes crucial before any attempt to implement such technology in clinical medicine is even entertained.
This study should be replicated with a larger sample size and better methodology, such as randomization and blinding the investigator, to avoid having biased results influenced by many confounding factors not adjusted for in the study.
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