Digital Inhaler With Built-In Sensors Wins FDA Approval

For patients with chronic obstructive pulmonary disease (COPD) or asthma, tracking use of inhalers that deliver vital medications can be a challenge. A recently approved device may help ensure that treatment is administered correctly.
In late December 2018, the Food and Drug Administration (FDA) approved a new digital inhaler from Teva Pharmaceuticals designed to help ensure individuals take their medications correctly. The inhaler features sensors that connect to a smartphone app, then record data that can be shared with clinicians who can assess a patient’s inhaler use.
appreciate 70 to 90 percent of patients make mistakes with their inhalers and don’t get enough medication into their lungs, while other patients may overuse the devices, according to the A study published in July 2016 in the journal Respiratory medicine.
While This type of sensor is not newThe ProAir Digihaler is the first digital inhaler with built-in sensors that detect when the inhaler is used and spirometry.
“Unlike currently installed devices, which are add-ons applied to the top of the inhaler, the technology in the ProAir Digihaler is built directly into the inhaler itself,” says Tushar Shah, MD, global head of specialist clinical development at ProAir Digihaler. Teva Pharmaceuticals.
Teva plans to roll out the product to a small number of users and suppliers this year in order to bring together the “real world” experience, and then launch the inhaler nationwide in 2020.
At this time, the device will only be available for rapid-release albuterol inhalation powder. The US Food and Drug Administration has approved the use of the inhaler in people 4 years of age and older to treat or prevent bronchospasm with reversible obstructive airway disease (such as asthma and some forms of COPD) and to prevent exercise-induced bronchospasm.
Bronchospasm causes a sudden tightening of the airways, often resulting in shortness of breath during breathing. Albuterol quickly relaxes the lung muscles, improving the diameter of the airways so that people can breathe more comfortably.
Helping patients take their medication properly
“Using this technology first in a rescue inhaler makes a lot of sense because patients can overuse it without knowing it,” he says. Todd Maher, MDan allergist at Gundersen Health System in La Crosse, Wisconsin, and president of American College of Allergy, Asthma & Immunology.
“They can accidentally grab the inhaler by mistake [instead of their daily maintenance inhaler]. “It happens all the time,” says Dr. Maher. “So they use the wrong inhaler twice a day, every day. With this device, we were able to see something wrong, communicate with them, and check back.”
Barbara B. Yeon, MDchief science officer at COPD FoundationHe adds that data from the inhaler may show whether a patient is taking too many puffs or not getting enough of the medication.
“Getting this information would be a warning sign – a yellow light – telling us that something different is happening and that we need to explore what it is,” says Dr. Yawn.
Possibility of daily use
Yawn and Mahr see the potential of the technology applied to daily long-acting inhalers.
“One of the biggest problems we have is people not being able to take their medication once or twice a day on a regular basis,” says Yawn, noting that only about 40 to 50 percent of patients with COPD take their medication regularly. “This type of device could give us a more direct measure of their ability to follow this system.”
A yawn and a dowry say two of the biggest questions will be the cost and whether insurance will cover it. At this time, Dr. Shah says Teva cannot comment on the cost until it becomes commercially available.
Insurance can currently cover some or all of the costs of inhalers. Consumer Information Site Health.CostHelper.com The average price for albuterol and an inhaler is estimated to be between $30 and $60. Most Delivery of 200 puffs.
Will health professionals accept the new technology?
Chris GarveyThe technology is interesting, but we don’t fully understand whether usage-monitoring inhalers can improve the patient-physician interface and improve patient outcomes, says a family nurse at UCSF Sleep Disorders and Pulmonary Rehabilitation.
“Physicians have an amazing amount of patient information, which can be an asset and sometimes a burden,” Garvey says. “Although it is not clear if it would be an effective clinical tool, I think the concept is good.”
Lynne Horowitz, MD, a pulmonologist at Lenox Hill in New York City, agrees.
“It’s nice data, but I don’t see a benefit,” he says. “For patients with controlled asthma, if they need an inhaler more than twice a week, they should simply call their doctor.”
“They will have to convince doctors that it has an advantage,” Garvey says. “The more we communicate with our patients and understand their medication needs and usage patterns, the more we will understand how to help them. The potential for this inhaler to be beneficial to the clinician exists.”