Patients with severe or mild asthma are likely to find relief with as needed Airsupra (albuterol-budesonide) versus albuterol alone, according to the study, “As-Needed Albuterol–Budesonide in Mild Asthma.” The study results, which were published in the New England Journal of Medicine, were significant.
More than 2,500 people aged 12 and older participated in the phase 3b virtual, multicenter BATURA trial. Patients were eligible for the trial if their mild asthma remained uncontrolled despite standard treatment and were randomly assigned to receive a fixed-dose combination of albuterol–budesonide or albuterol alone for up to 52 weeks.
“More than half of people with asthma in the U.S. have mild disease, and many still rely on albuterol alone,” Liz Bodin, BA Hons, told Healio. Bodin is vice president of U.S. respiratory and immunology at AstraZeneca, the manufacturer of Airsupra. “While albuterol can ease symptoms, it does not address the underlying inflammation that raises the risk of exacerbations.”
Only 5.1% of those using the combination therapy experienced a severe asthma attack, compared to 9.1% in the albuterol-only group. The hazard ratio was 0.53, indicating nearly a 50% reduction in risk. Similar results were observed in the intention-to-treat population, with a hazard ratio of 0.54.
Additionally, the annualized rate of severe exacerbations was halved in the combination group (0.15 versus 0.32), and participants required significantly less systemic glucocorticoid treatment (23.2 mg versus 61.9 mg per year). Adverse events were comparable between both groups.
Based on these results, the U.S. Food and Drug Administration (FDA) updated the prescribing information for Airsupra to include that it lowers the risk for severe asthma exacerbations versus albuterol alone in mild asthma.
The trial was funded by Bond Avillion 2 Development and AstraZeneca and was halted early due to the clear efficacy of the combination therapy. According to researchers, the findings suggest a promising shift in how mild asthma may be managed, potentially improving outcomes for millions of patients.
