Smart Inhalers May Enable Better Management of Respiratory Disorders

by Rachel Muenz | Jun 15, 2022 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Special Focus-dtet

Inhalers and sensors that offer digital monitoring are beginning to gain FDA approval, and could solve usage issues of traditional products.

A selection of medication inhalers in a row — Though established inhalers for managing these conditions have a number of issues, a relatively new option on the market—smart inhalers—could help solve some of these challenges.

Asthma and chronic obstructive pulmonary disease (COPD) cost big bucks in the US, both in terms of direct and indirect costs to society as well as their toll on life and health. According to the Asthma and Allergy Foundation of America (AAFA)¹, there are about 25 million people living in the US with asthma; according to the CDC, nearly 15.7 million people have COPD, which was the fourth leading cause of death in the US in 2018². Though established inhalers for managing these conditions have a number of issues, a relatively new option on the market—smart inhalers—could help solve some of these challenges.

What Are Smart Inhalers?

Smart inhalers include a variety of digital monitoring features that track many different metrics, including dosage, usage, and even the patient’s technique. They include devices that come as an entire unit, or those that attach to a standard inhaler to turn it into a smart device.

The Advantages of Smart Inhalers

While research is lacking on smart inhalers, what does exist shows many advantages of this technology. These devices are able to do some or all of the following:

Record when the inhaler was used
Remind users when to take their next dose
Analyze their usage technique by measuring inspiratory flow rate—basically, how quickly a patient’s lungs fill to a certain capacity when breathing in³
Provide feedback on timing and technique of inhaler use
Transfer the above data to the patient’s health care provider so that professionals can ensure patients are taking their medication and using proper technique

The Diagnostic Challenge

In terms of monetary costs, the AAFA estimates the total cost of asthma on society to be $56 billion and the CDC estimated the bill for COPD in 2020 to be around $49 billion^4,5. With so many living with these conditions and the associated costs so high, proper diagnosis and management of asthma and COPD is critical. Metered dose inhalers (MDIs), dry powder inhalers (DPIs), and soft mist inhalers (SMIs) are the more established options available for managing breathing difficulties associated with these conditions.

A Breakdown of the Options

MDIs

The most commonly used treatment option, these devices include a small, pressurized canister of medication set into a plastic holder with a mouthpiece. They are less costly than the other options and provide a consistent dose of medicine when sprayed, as long as they are used correctly. The coordination required for their use may be difficult for some patients.

With MDIs being the most commonly used tool for managing the symptoms of asthma and COPD, it’s important to note the key drawback of this particular inhaler—high potential for misuse, which leads to additional costs.

According to a 2005 Respiratory Care study, 28 to 68 percent of patients do not use MDIs or powder inhalers properly enough to benefit from the medication they contain, and 39 to 67 percent of health care professionals don’t explain how to use MDIs well enough⁶. A 2017 article from the same journal showed that with proper education, patients eventually mastered proper inhaler use technique, but it took longer with MDIs than with DPIs⁷.

A 2020 review article published in the Expert Review of Respiratory Medicine states that, of the $50 billion spent on inhalers for respiratory conditions, the cost of improper inhaler use is an estimated $7 to $15 billion each year⁸.

DPIs

These inhalers involve a round canister that holds the medicine in a dry powder form. This option requires users to pull a lever or push a button and some require users to insert a capsule before use. Patients also need to breathe hard and fast to get the medicine into their lungs, which may pose challenges to those with physical or cognitive impairments. While research has shown this option is more effective and less prone to misuse than MDIs, they are more expensive than MDIs.⁹

SMIs

With soft mist inhalers, since the medicine is contained in a fine mist, more of it gets into the patient’s lungs, however, it’s more difficult to load the medication into the device and research has linked some options to a higher risk of death in COPD patients¹⁰.

How Smart Inhalers Could Solve Challenges of Traditional Devices

As pointed out in a Frontiers in Medical Technology review, smart inhalers encourage patients to adhere to their medication schedules as they know their activities are being recorded and the data collected allow health care providers to compare how well patients use their inhalers and follow their medication schedules¹¹. Adhering to these schedules is important as failing to take their medications or failing to take them properly leads to “poor clinical outcomes, reduced quality of life, and high health care and societal costs,” for asthma and COPD patients, according to a 2021 Journal of Thoracic Disease review¹². Those societal costs include impaired ability to work and excess hospitalizations.

The authors state that smart inhalers could be an important tool in solving such adherence issues and reducing the costs of asthma and COPD: “Recently developed smart inhalers could be the key to objectively diagnose and manage non-adherence effectively in patients with asthma and chronic obstructive pulmonary disease.” However, they point out that smart inhalers’ budget impact and cost-effectiveness need to be looked at more closely before they are adopted more widely, concluding that for patients with severe asthma or COPD, smart inhalers could be more cost-effective than traditional options.

Current Smart Inhalers on the Market

While the monitoring ability offered by smart inhalers has been around for roughly 30 years, it has only recently become available in its current compact and easy-to-use form. Smart inhalers have also only very recently begun gaining approval by the FDA—the first smart inhaler granted FDA was Teva's ProAir Digihaler, which gained FDA approval at the end of 2018. The Digihaler line includes several other products that have also recently been FDA approved. The first platform that turns regular inhalers into smart devices to receive FDA approval was Propeller Health’s Propeller platform, which pairs with GlaxoSmithKline’s dry powder inhaler, Ellipta, gaining approval in 2016. Other FDA-approved sensors that turn regular inhalers into smart versions include Cognita Labs’ CapMedic, which gained approval in 2020, BreatheSuite Inc.’s Metered-Dose Inhaler (MDI) V1 device and Adherium Limited’s Hailie® Sensor, both of which gained approval in September 2021.

There are many other options available that haven’t yet been FDA approved, such as Sensirion’s smart inhaler and Aptar Pharma’s HeroTracker^® Sense, another device that turns regular MDIs into smart inhalers. This CE marked device was officially launched in 2022 and is currently pending FDA approval.

Market Outlook for Smart Inhalers

In addition to the benefits they provide to patients, smart inhalers seem like they will enjoy decent market growth. Analysis released by Persistence Market Research at the end of 2021 predicts the industry will hit a net worth of $1 billion US by the end of 2031, at a compound annual growth rate of 23.5 percent. That growth will be driven by the increasing frequency of respiratory disorders and the subsequent rise in demand for therapies and treatment of these conditions¹³.

As more smart inhaler products come on the market and gain FDA approval, and more health care professionals recommend them, more patients will experience the benefits, which should, in turn, drive further growth. Much of that growth will likely be in North America, which currently accounts for the largest share of the global market, according to the report.