Albuterol/Budesonide Label Updated to Include Clinically Meaningful Evidence From BATURA Study

The US prescribing information for albuterol/budesonide (Airsupra; AstraZeneca) was updated to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared with albuterol. The prescribing information was updated based on findings from the BATURA clinical trial (NCT05505734).^1,2

Albuterol/budesonide, formerly known as PT027, is a first-in-class short-acting beta-agonist/inhaled corticosteroid rescue treatment for asthma that is taken as needed. It is an inhaled, fixed-dose combination rescue medication that is currently FDA-approved for the treatment or prevention of asthma-related symptoms and to prevent sudden severe breathing problems (eg, asthma attacks or exacerbations) in patients aged 18 years and older.¹ Its initial approval was based on results from the phase 3 MANDALA (NCT03769090) and DENALI trials (NCT03847896).^1,3,4

“This label update approved by the FDA ensures that the critical evidence for [albuterol/budesonide] in mild asthma is now included in the prescribing information, allowing physicians to make the most informed decisions about rescue medicine for their patients. This update, along with the recent GINA Report, supports an anti-inflammatory rescue approach for adults of all asthma severities,” Reynold A. Panettieri Jr, MD, vice chancellor and professor of medicine at Rutgers Institute for Translational Medicine and Science, said in a news release.¹

BATURA was a US-based, randomized, double-blind, parallel-group phase 3b clinical trial that compared the efficacy and safety of inhaled albuterol/budesonide (180 mcg/160 mcg) as an as-needed rescue medication in response to symptoms compared with as-needed inhaled albuterol (180 mcg) for up to 12 months. Patients with asthma aged 12 years and over with intermittent or mild persistent asthma were recruited and randomly assigned to the albuterol/budesonide (n = 1209) or albuterol (n = 1212) group.^1,2,5

The trial’s primary end point was the time to first severe asthma exacerbation (defined as a worsening of symptoms that result in ≥ 3 days of systemic corticosteroid use, an emergency department visit, urgent care visit, asthma-related hospitalization, or death) during the study period. Secondary end points included annualized severe exacerbation rate and annualized total systemic corticosteroid dose.^1,2,5

The findings demonstrated that albuterol/budesonide had significantly reduced the risk of a severe exacerbation by 46% (hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.40–0.72; p < .001) when compared with albuterol in adult patients with mild asthma. A severe exacerbation occurred in approximately 5.1% of those in the albuterol/budesonide group and in 9.1% of those in the albuterol group in the on-treatment efficacy population (HR: 0.53; 95% 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). Additionally, the mean annualized total dose of systemic glucocorticoids was lower in the albuterol/budesonide group (23.2 mg per year) compared with albuterol (61.9 mg per year).^1,5

The investigators wrote that adverse events were similar in the 2 treatment groups. Of note, although patients aged 12 to 17 years of age were enrolled and included in the BATURA trial, this updated US prescribing update is not indicated for that age group.^1,5

“Patients living with asthma deserve a treatment that offers more than just relief from their symptoms. With this label update for [albuterol/budesonide], which includes proven benefits for mild asthma, patients across all asthma severities have a superior choice for their asthma rescue medication,” Liz Bodin, vice president, US Respiratory & Immunology, AstraZeneca, said in the news release.¹

REFERENCES

1. AstraZeneca. AIRSUPRA® (albuterol/budesonide) US prescribing information updated to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared with albuterol. News release. September 18, 2025. Accessed September 29, 2025. https://www.astrazeneca-us.com/media/press-releases/2025/AIRSUPRA-albuterol-budesonide-US-prescribing-information-updated-to-reflect-the-statistically-significant-severe-exacerbation-risk-reduction-in-patients-with-mild-asthma-compared-with-albuterol.html

2. A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma. ClinicalTrials.gov identifier: NCT05505734. Updated August 3, 2025. Accessed September 29, 2025. https://clinicaltrials.gov/study/NCT05505734

3. A Study to Assess the Efficacy and Safety of Budesonide/​Albuterol Metered-dose Inhaler (BDA MDI/​PT027) in Adults and Children 4 Years of Age or Older With Asthma (MANDALA). ClinicalTrials.gov identifier: NCT03769090. Updated September 28, 2022. Accessed September 29, 2025. https://clinicaltrials.gov/study/NCT03769090

4. A Study to Assess the Efficacy and Safety of Budesonide/​Albuterol Metered Dose Inhaler (BDA MDI/​PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma (DENALI). ClinicalTrials.gov identifier: NCT03847896. Updated April 13, 2023. Accessed September 29, 2025. https://clinicaltrials.gov/study/NCT03847896

5. LaForce C, Albers F, Danilewicz A, et al. As-Needed Albuterol–Budesonide in Mild Asthma. N Engl J Med. 2025;393(2):113-124. doi:10.1056/NEJMoa2504544