BATURA Trial Shows Airsupra Reduces Severe Asthma Exacerbation Risk in Patients with Mild, Intermittent Asthma

Credit: Sebastian Kaulitzki | stock.adobe.com

Treatment with Airsupra (albuterol/budesonide; AstraZeneca, Avillion) as a rescue medication was found to significantly lower the risk of severe asthma exacerbations in patients with intermittent or mild persistent asthma compared to albuterol alone, according to results of the Phase IIIb BATURA trial (NCT05505734).^1,2 The first-in-class, pressurized metered-dose inhaler, fixed-dose combination rescue treatment was approved by the FDA in January 2023 for as-needed treatment or to prevent bronchoconstriction and to lower the risk of exacerbations in patients with asthma aged 18 years and older.³

“People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control,” said James Donohue, Emeritus Professor of Pulmonary Medicine, University of North Carolina, and chair, Independent Data Monitoring Committee, in a press release. “By focusing on patients with intermittent or mild persistent asthma, the strong BATURA trial results further demonstrate the clinically meaningful benefit of an anti-inflammatory rescue approach to reduce the risk of severe exacerbations by treating both symptoms and inflammation at the same time.”¹

The randomized, double-blind, parallel-group, event-driven BATURA trial analyzed the efficacy and safety of inhaled Airsupra (180 mcg/160 mcg) as an as-needed rescue treatment vs. as-needed albuterol (180 mcg) for up to 12 months. Investigators enrolled patients 12 years of age and older with intermittent or mild persistent asthma.

Patients were required to have been using an as-needed short-acting beta2-agonist (SABA) alone or using as-needed SABA on a background of either low-dose inhaled corticosteroid or a leukotriene receptor agonist to treat asthma. The trial’s primary endpoint was time to first severe asthma exacerbation during the study, with secondary endpoints that included severe exacerbation rate and total systemic corticosteroid use.

The results showed a statistically significant and clinically meaningful decease in the risk of severe asthma exacerbation with Airsupra used as an as-needed rescue therapy in response to symptoms compared to as-needed albuterol. In terms of safety, the profile of Airsupra was consistent with what has previously been reported, with no new safety concerns identified. The most common adverse events associated with Airsupra in previous clinical trials are nasopharyngitis and headache.

Airsupra was approved by the FDA last year based on findings from the Phase III MANDALA and DENALI trials. The MANDALA trial showed that Airsupra as an as-needed rescue medication significantly lowered the risk of severe asthma exacerbations compared with albuterol in patients with moderate to severe asthma in response to symptoms.

Further, Airsupra produced a significant reduction in the trial’s secondary endpoint of mean annualized total systemic corticosteroid exposure at the approved dose of 180 mcg albuterol/160 mcg budesonide compared with albuterol. The DENALI trial showed that Airsupra significantly improved lung function compared to individual albuterol and budesonide in patients with mild to moderate asthma.

Investigators are currently evaluating Airsupra in individuals aged 12 to <18 years with asthma in the Phase III ACADIA trial and among patients in China in the Phase III BAIYUN trial. Full data from the BATURA trial will be shared with health authorities and presented as a late-breaker oral presentation at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting on later this month.

“The impressive BATURA trial results add to the body of evidence supporting Airsupra as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids,” said Sharon Barr, executive vice president, BioPharmaceuticals R&D, AstraZeneca, in a press release.¹

References

1. Airsupra demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial. News release. AstraZeneca. October 7, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/airsupra-positive-results-phase-iii-batura-trial.html#!

2. A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma. ClinicalTrials.gov. Updated August 29, 2024. Accessed October 7, 2024. https://clinicaltrials.gov/study/NCT05505734

3. Airsupra (PT027) approved in the US for asthma. News release. AstraZeneca. January 11, 2023. Accessed October 7, 2024. https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html