WILMINGTON, DE — AstraZeneca has announced groundbreaking results from the BATURA Phase IIIb trial for AIRSUPRA (albuterol/budesonide), marking a significant advancement in asthma care. The anti-inflammatory rescue therapy demonstrated substantial improvements across all primary and secondary endpoints, reducing severe exacerbations and aligning with global asthma management guidelines.
The trial delivered a 47% reduction in severe exacerbation risks when using AIRSUPRA as-needed, compared to the widely used albuterol-alone therapy. These results, coupled with earlier successes in the MANDALA and DENALI trials, reflect a compelling case for AIRSUPRA as a preferred standard of care for asthma across all severity levels. Notably, the BATURA trial was halted early due to overwhelming efficacy identified in a pre-specified interim analysis, as recommended by the Independent Data Monitoring Committee.
Craig LaForce, MD, Medical Director of North Carolina Clinical Research, hailed the findings as revolutionary. “The unprecedented BATURA trial results provide an opportunity to change 50 years of clinical practice in asthma. For decades, millions of patients have relied on albuterol-only rescue treatments, leaving them unprotected against increasing airway inflammation. AIRSUPRA not only offers immediate relief but also prevents future, more severe exacerbations across all asthma severities.”
The BATURA findings come as mild asthma, which affects 50% to 70% of patients, continues to pose underestimated risks. AIRSUPRA’s unique ability to offer immediate symptom relief while addressing underlying inflammation positions it as a vital tool in asthma management. According to Tonya Winders, President of the Global Allergy and Airways Patient Platform, “Patients with asthma often face unexpected exacerbations. Using an anti-inflammatory reliever transforms every rescue inhaler use into early intervention, helping prevent attacks and reducing exposure to systemic steroids.”
AIRSUPRA also delivered a 63% reduction in systemic corticosteroid exposure among adults and adolescents aged 12 and older, significantly mitigating long-term health risks associated with corticosteroid use, such as cardiovascular disease and osteoporosis. Safety findings confirmed AIRSUPRA’s tolerance profile as consistent with earlier trials, with no clinically meaningful differences between it and albuterol-alone therapy.
Sharon Barr, Executive Vice-President and Head of BioPharmaceuticals R&D at AstraZeneca, expressed optimism about the implications of the trial. “The exciting results from the BATURA trial, coupled with MANDALA and DENALI, clearly demonstrate AIRSUPRA’s superiority over albuterol across all asthma severities. We hope these comprehensive results accelerate the adoption of anti-inflammatory rescue therapy as the preferred standard of care.”
AIRSUPRA represents the first and only US-approved anti-inflammatory rescue medication, suitable for asthma treatment or prevention in adults aged 18 and older. Outside the US, AIRSUPRA has gained approval in the UAE, Kuwait, Bahrain, Qatar, and Oman, with ongoing research extending its reach globally.
The BATURA trial’s publication in the New England Journal of Medicine and presentation at the ATS 2025 International Conference further validate AIRSUPRA’s potential to redefine asthma care. AstraZeneca remains at the forefront of innovation, aiming to elevate global asthma treatment with cutting-edge solutions like AIRSUPRA.
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