BATURA Phase IIIb Trial Establishes Airsupra as a New Standard for As-Needed Asthma Rescue Treatment
AstraZeneca has released the full results from its pivotal BATURA Phase IIIb trial, revealing that the anti-inflammatory rescue therapy Airsupra (a fixed-dose combination of albuterol and budesonide) delivered both statistically significant and clinically meaningful improvements across all primary and secondary endpoints compared to traditional albuterol rescue inhalers in patients with mild asthma. These landmark findings, now published in the New England Journal of Medicine and presented at the 2025 American Thoracic Society (ATS) International Conference in San Francisco, are poised to reshape the treatment paradigm for millions of individuals managing asthma worldwide.
Redefining Rescue Treatment in Asthma
For decades, albuterol, a short-acting beta-agonist (SABA), has remained the cornerstone of as-needed rescue therapy for asthma. However, albuterol only addresses bronchoconstriction and fails to tackle the underlying airway inflammation that drives asthma exacerbations. The BATURA trial evaluated Airsupra’s dual-action mechanism by comparing its efficacy to albuterol alone when used on an as-needed basis in individuals with mild asthma—a population that represents a significant proportion of asthma sufferers yet is often overlooked in clinical risk assessments.
The trial enrolled over 3,000 patients across multiple centers and was designed to rigorously assess the ability of Airsupra to reduce severe asthma exacerbations in a real-world, as-needed treatment setting. The results were compelling: Airsupra reduced the risk of severe asthma exacerbations by 47% compared to albuterol alone (event rate: 5.1% vs. 9.1%; hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.39 to 0.73; p<0.001). This profound efficacy benefit led the Independent Data Monitoring Committee (IDMC) to recommend early termination of the trial at a pre-specified interim analysis due to the overwhelming clinical benefit demonstrated.
Building on a Robust Clinical Foundation
BATURA is not AstraZeneca’s first major clinical trial exploring Airsupra’s capabilities. It follows the MANDALA and DENALI Phase III trials, which established the safety and effectiveness of Airsupra in moderate to severe asthma. The totality of evidence from BATURA, MANDALA, and DENALI paints a consistent picture: Airsupra offers superior protection against exacerbations compared to albuterol across the full spectrum of asthma severity.
Importantly, these clinical findings align with the latest recommendations from the Global Initiative for Asthma (GINA), which now endorses the use of anti-inflammatory reliever combination therapy as the preferred rescue option—even in patients with mild asthma. This shift reflects growing recognition of the risks associated with under-treating airway inflammation, particularly in individuals who may appear to have “mild” disease but remain susceptible to sudden, severe attacks.
The Unseen Risk of Mild Asthma
It is a common misconception that patients with mild asthma are largely safe from exacerbations. In reality, 50% to 70% of all asthma patients are classified as having mild asthma, yet these individuals are responsible for a substantial portion—up to 30%—of asthma-related hospitalizations and deaths. Such outcomes often occur due to an overreliance on SABAs like albuterol that provide symptomatic relief but no anti-inflammatory action.
Dr. Craig LaForce, Medical Director at North Carolina Clinical Research, emphasized this point in his remarks:
“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 treatment, leaving them unprotected against airway inflammation that can escalate into a serious attack. Airsupra offers a paradigm shift—not only relieving symptoms but preventing future exacerbations by addressing the root cause of inflammation.”
Reducing Systemic Steroid Exposure
In addition to reducing the frequency of severe attacks, Airsupra also demonstrated a 63% reduction in total systemic corticosteroid (SCS) exposure in adults and adolescents aged 12 and older compared to albuterol alone (p<0.001). SCS are frequently prescribed during asthma exacerbations to control inflammation but are associated with serious adverse effects, even after only 1–3 short treatment courses. These risks include increased susceptibility to type 2 diabetes, mood disorders, cardiovascular disease, renal impairment, cataracts, fractures, and pneumonia.
By preventing exacerbations before they escalate, Airsupra reduces the need for systemic steroid interventions and thus contributes to long-term patient safety and improved quality of life. Notably, the same magnitude of benefit was observed in a prespecified subgroup of adult patients aged 18 and older, reinforcing the therapy’s efficacy in older demographics as well.
A Favorable Safety Profile
Safety data from BATURA confirmed that Airsupra’s tolerability remains in line with its well-established safety profile observed in prior trials. There were no clinically meaningful differences in adverse events between the Airsupra and albuterol groups, supporting its suitability for long-term, as-needed use.
This is critical for a rescue therapy intended for unpredictable, self-administered use. Patients can be confident in the reliability of the medication not only for symptom control but also in minimizing potential complications from therapy itself.
Transformative Potential for Asthma Management
From a patient advocacy perspective, the BATURA trial findings have been met with optimism. Tonya Winders, President of the Global Allergy and Airways Patient Platform (GAAPP), remarked:
“Patients who live with asthma are often at risk for unexpected exacerbations. Using an anti-inflammatory reliever therapy transforms every use of a rescue inhaler into an opportunity for early intervention to address the underlying inflammation of asthma. This is particularly important for patients with mild asthma, whose risks are frequently underestimated.”
The promise of Airsupra lies not only in reducing immediate symptoms but in offering a proactive, inflammation-targeting approach with every rescue use. This aligns with the modern understanding of asthma as a chronic inflammatory condition requiring more than symptom suppression.
AstraZeneca’s Ongoing Commitment
Sharon Barr, Executive Vice President and Head of BioPharmaceuticals R&D at AstraZeneca, summed up the broader significance of the BATURA results:
“The exciting results from the BATURA trial, coupled with the findings from MANDALA and DENALI, clearly demonstrate the superiority of Airsupra over albuterol alone across all asthma severities. We hope these comprehensive results accelerate the use of anti-inflammatory rescue therapy as the preferred standard of care, in line with recommendations from the Global Initiative for Asthma.”
Airsupra is currently approved in the United States for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in adults aged 18 years and older. It stands as the first and only anti-inflammatory rescue therapy approved for this indication. Further studies are underway to expand its use to adolescents aged 12–17 in the ACADIA Phase III trial, and to patients in China via the BAIYUN Phase III trial. The therapy was jointly developed by AstraZeneca and Avillion, underscoring the collaborative innovation driving respiratory care forward.
A New Era in Asthma Rescue Care
The BATURA Phase IIIb trial marks a significant inflection point in asthma management. With robust data demonstrating substantial reductions in both exacerbations and corticosteroid use, Airsupra challenges the long-held dominance of albuterol monotherapy in rescue treatment. Its dual-action formula not only relieves symptoms but actively addresses the inflammation at the heart of asthma—making it a superior alternative for the millions living with this chronic condition.
As asthma treatment guidelines evolve, and regulatory bodies take note of the compelling BATURA data, Airsupra is well positioned to become the new gold standard for as-needed therapy, offering both immediate relief and long-term protection for patients across the spectrum of asthma severity.
