ProAir Digihaler Shows Promise Treating Poorly Controlled Asthma


ProAir Digihaler Inhalation Powder is indicated for the treatment or prevention of bronchospasm in those with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

A recent study based around newly established clinical thresholds on the use of short-acting beta agonists (SABA) show the potential of real-world SABA use among individuals with asthma and illustrate the efficacy of the ProAir Digihaler (albuterol sulfate; Teva Pharmaceutical Industries) inhalation powder, according to a Teva press release.

The study found that approximately one-third of patients with asthma had 138 or more inhalations over the course of a 12-week study period, equal to 600 or more inhalations, or 3 or more canisters per year, according to the study. The authors defined valid inhalations as events in which the patient inhales at a peak inspiratory flow (PIF) rate between >18 to <120 liters/minute with no errors in use.

“Many patients with poorly controlled asthma rely on SABA when they have an asthma exacerbation,” said lead study author Njira Lugogo, MD, clinical associate professor, University of Michigan, in a press release. “Our research shows that there is a gap between clinical recommendations and real-world management of asthma, and shows how digital tools, such as ProAir Digihaler, may help address some of these challenges.”

The ProAir Digihaler Inhalation Powder is a prescription drug indicated for individuals ≥4 years of age for the treatment or prevention of bronchospasm in those with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. The Digihaler includes built-in sensors that gather personal inhaler data to allow patients to track and share these data.

According to the study authors, the results show the first application of evidence-based clinical statements from an independent US expert consensus identifying the risk of asthma exacerbation, including the risk of a life-threatening episode, based on SABA overuse. Further, the study indicates that digital inhalers may help health care providers identify SABA reliever overuse to help guide individualized clinical decision-making based on insights from objective patient SABA reliever usage data downloaded directly from the ProAir Digihaler, according to the authors.

For the study, SABA use data downloaded from 359 patients’ ProAir Digihaler devices were used to apply and validate clinical action thresholds for risk associated with SABA overuse and established by independent expert consensus. Patients made 1 or more valid inhalations—PIF >18 to <120 with no errors in use—from a ProAir Digihaler device over a 12-week period.

The investigators noted that elevated SABA use among patients with sub-optimally controlled asthma was more common than previously understood.

The study found that 89% (319/359) of patients met the consensus threshold of SABA reliever medication use ≥100% above baseline for 1 or more study weeks and that 72% (260/359) reached the threshold of SABA reliever medication use ≥200% above baseline, as determined by independent consensus to likely indicate impending or ongoing exacerbation.

Further, 17% (62/359) of patients had 25 or more valid inhalations in a week, which was associated with unanimous consensus of likely impending or ongoing exacerbation, including 14% (40/295) of patients who did not have a confirmed exacerbation.

Approximately one-third of patients (29%, 104/359) showed a SABA reliever use rate over 12 weeks equal to 3 or more canisters per year, which was determined by consensus to be associated with a greater risk of asthma exacerbation and death. Among this group included 52% (33/64) of patients with asthma exacerbations over the study period and 24% (71/295) who did not have confirmed exacerbations.

“These findings shed important light on patients’ real-world use of SABA and the potential of objective data from digital health tools like ProAir Digihaler to help inform treatment decisions,” said Tanisha Hill, senior medical director, Respiratory and Digital Health Medical Lead at Teva, in a press release. “The findings suggest that, with ProAir Digihaler, accurate and objective data on reliever inhaler use can help facilitate treatment discussions between providers and patients.”


Teva Announces New Findings Highlighting Potential of ProAir® Digihaler® (albuterol sulfate) Inhalation Powder to Address Asthma Treatment Challenges. Teva Pharmaceuticals. News release. July 7, 2022.

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