Smart sensor cleared for use with AZ asthma, COPD inhalers

A high-tech device that can monitor medication use and compliance has been cleared by the FDA for use with AstraZeneca’s Airsupra and Breztri inhalers.

Developed by Australian medtech firm Adherium, the Hailie Smartinhaler takes the form of a Bluetooth-enabled sensor that clips over an inhaler and communicates data on the use of the device to the cloud.

That data can be used to check that a patient is using the correct technique to get a benefit from the inhaler, for example, and give patients and healthcare providers a view of how well they are adhering to treatment via an app and associated portal.

AZ’s Airsupra (albuterol and budesonide) – developed with Avillion – was approved by the FDA last year for as-needed treatment or prevention of asthma symptoms and to help prevent asthma attacks in people aged 18 years and older. It was the first anti-inflammatory-based rescue medicine to be cleared for this use in the US, showing superior results compared to albuterol alone in phase 3 trials.

Breztri (budesonide/glycopyrrolate/formoterol fumarate), meanwhile, has been approved since 2020 in the US as a maintenance treatment used to reduce exacerbations in people living with chronic obstructive pulmonary disease (COPD).

Sales of Breztri were $677 million last year, a rise of 73%, although AZ does not yet break out Airsupra revenues individually, as it is still in the rollout phase.

The Hailie Smartinhaler device has also been cleared for use with inhalers from other manufacturers, including GSK, Boehringer Ingelheim, and Teva, and Adherium also sells the device directly to patients with asthma and COPD under a 510(k) over-the-counter clearance.

In a statement, the company said the Breztri approval means the device is now approved for use with all triple-therapy inhalers in the US market.

Adherium’s chief executive, Dr Paul Mastoridis, said: “Our mission at Adherium has always been to revolutionise the way respiratory conditions are managed.

“By securing FDA clearance for our Smartinhaler with Airsupra and Breztri, we are bringing that vision to life, offering patients and healthcare providers a powerful tool in the fight against chronic respiratory diseases,” he added. “This is just the beginning of our journey to transform respiratory care.”

A recent report from Persistence Market Research concluded that the global market for smart inhaler devices that enable real-time tracking of medication usage, provide feedback to patients, and assist healthcare providers in remote monitoring is currently worth around $80.5 million and is predicted to grow more than 10% a year to reach $236 million in 2033.