As-Needed Rescue Treatment with Albuterol–Budesonide for Mild Asthma, with Monica Kraft, MD

BATURA phase 3 trial results are providing new evidence supporting albuterol/budesonide (Airsupra)’s benefit as standard of care for as-needed rescue treatment in patients with asthma.1,2

The data were presented at the American Thoracic Society (ATS) International Conference 2025 and published in the New England Journal of Medicine and highlight a 47% reduced risk of severe exacerbations in mild asthma with albuterol/budesonide compared with albuterol alone.1

“Our guidelines are a little antiquated when it comes to mild asthma here in the US,” Monica Kraft, MD, Murray M. Rosenberg Professor of Medicine and System Chair for the Department of Medicine at Mount Sinai Health System and the Icahn School of Medicine at Mount Sinai, explained to HCPLive. “I think we have now appreciated that mild asthma really isn't always mild, that many patients who have mild asthma have significant asthma exacerbations. I think we've misperceived it over the years, that mild asthma is just something not to worry about.”

Kraft goes on to describe a recent shift toward prioritizing exacerbation reduction and prevention, drawing comparisons to how doctors treat blood pressure long-term to prevent strokes and cholesterol to prevent cardiac issues. She additionally describes Airsupra as "a great addition to our asthma armamentarium."

Airsupra, formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol and budesonide and has been developed in a pressurised metered-dose inhaler using AstraZeneca’s Aerosphere delivery technology.2

BATURA was a phase 3b, US, randomised, double-blind, parallel-group, event-driven trial, comparing the efficacy and safety of using inhaled albuterol/budesonide (180mcg/160mcg) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol (180mcg) for up to 12 months.2

A total of 2516 participants underwent randomization, of whom 1797 (71.4%) completed the trial. Of 2421 participants in the full analysis population (1209 assigned to the albuterol–budesonide group and 1212 to the albuterol group), 97.2% were ≥ 18 years of age and 74.4% used a SABA alone at baseline.1

The trial was stopped for efficacy at a prespecified interim analysis. A severe exacerbation occurred in 5.1% of the participants in the albuterol–budesonide group and in 9.1% of those in the albuterol group in the on-treatment efficacy population (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.39-0.73) and in 5.3% and 9.4%, respectively, in the intention-to-treat population (HR, 0.54; 95% CI, 0.40-0.73) (P <.001 for both comparisons).1

The annualized rate of severe asthma exacerbations was lower with albuterol–budesonide than with albuterol (0.15 vs 0.32; rate ratio, 0.47; 95% CI, 0.34-0.64), as was the mean annualized total dose of systemic glucocorticoids (23.2 vs 61.9 mg per year). Adverse events were similar in the treatment groups.1

“The BATURA study showed us that even those patients with what we would consider very mild asthma can benefit from early anti-inflammatory therapy and ongoing anti-inflammatory therapy,” Kraft said. “I think we want to start thinking about that in terms of prevention, but also treating mild asthma appropriately, because mild asthma isn't always mild.”

Editors’ note: Kraft has relevant disclosures with AstraZeneca, Chiesi, Genentech, GlaxoSmithKline, Kinaset Therapeutics, Regeneron, and Sanofi.

References

1. LaForce C, Albers F, Danilewicz A, et al. As-Needed Albuterol–Budesonide in Mild Asthma. N Engl J Med. https://www.nejm.org/doi/full/10.1056/NEJMoa2504544

2. AstraZeneca. Statistically significant and clinically meaningful BATURA Phase III trial results provide new evidence for Airsupra as standard of care for as-needed rescue treatment in asthma. May 19, 2025. Accessed May 19, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/statistically-significant-clinically-meaningful-batura-phase-iii-trial-provide-evidence-airsupra-standard-care-as-needed-rescue-treatment-asthma.html