The Phase IIIb BATURA trial has demonstrated that AstraZeneca's Airsupra (albuterol/budesonide) significantly reduces the risk of severe asthma exacerbations by 47% compared to albuterol alone in patients with mild asthma. These groundbreaking results were published in the New England Journal of Medicine and presented at the American Thoracic Society (ATS) 2025 International Conference in San Francisco.
The trial evaluated Airsupra, an anti-inflammatory reliever rescue therapy, against albuterol, the most commonly used rescue medicine in the United States. Airsupra demonstrated statistically significant and clinically meaningful improvements across all primary and secondary endpoints.
Significant Reduction in Exacerbation Risk
In the on-treatment efficacy population, severe exacerbations occurred in only 5.1% of participants using Airsupra compared to 9.1% in the albuterol-only group (hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.39, 0.73; p<0.001). The efficacy was so pronounced that the Independent Data Monitoring Committee recommended early termination of the trial.
"The unprecedented BATURA trial results provide an opportunity to change 50 years of clinical practice in asthma," said Dr. Craig LaForce, Medical Director of North Carolina Clinical Research. "For decades, millions of patients have relied on albuterol-only rescue treatment in asthma, leaving them unprotected against the increasing airway inflammation that could lead to a more serious attack."
Reduced Steroid Exposure
A key secondary endpoint revealed that patients receiving Airsupra had 63% lower exposure to total systemic corticosteroids (SCS) over the treatment period compared to those using albuterol alone (p<0.001). This reduction is particularly significant as even 1-3 short courses of SCS are associated with increased risks of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia, and fracture.
Addressing a Critical Need in Mild Asthma
Mild asthma, affecting 50-70% of asthma patients, is often underestimated as a low-risk condition. However, people with mild asthma or infrequent symptoms represent up to 30% of all reported asthma-related exacerbations and deaths.
"Patients who live with asthma are often at risk for unexpected exacerbations," noted Tonya Winders, President of Global Allergy and Airways Patient Platform (GAAPP). "Using an anti-inflammatory reliever therapy can transform every use of a rescue inhaler into an opportunity for early intervention to address the underlying inflammation of asthma, helping to prevent attacks and reduce exposure to systemic steroids."
Comprehensive Evidence Across Asthma Severities
The BATURA trial builds upon previous Phase III MANDALA and DENALI trials, collectively demonstrating the benefit of as-needed Airsupra in reducing severe exacerbation risk across all asthma severities compared to albuterol alone.
"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," said Sharon Barr, Executive Vice-President and Head of BioPharmaceuticals R&D at AstraZeneca. "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."
Innovative Trial Design
BATURA was a Phase IIIb, US-based, randomized, double-blind, parallel-group, event-driven trial comparing as-needed Airsupra (180mcg albuterol/160mcg budesonide) to as-needed albuterol (180mcg) for up to 12 months. The study enrolled 2,421 patients aged 12 years and older with intermittent or mild persistent asthma.
The trial employed a first-ever decentralized, patient-centric design that allowed participants to accommodate trial-related activities around their daily lives, removing logistical barriers and increasing efficiency and equitable access to the study.
Safety Profile
Safety findings in the BATURA trial demonstrated that Airsupra was consistent with its well-established safety profile. There were no clinically meaningful differences in safety results between the Airsupra and albuterol groups.
Current Approval Status and Ongoing Studies
Airsupra is currently the first and only anti-inflammatory rescue medication approved in the US for as-needed treatment or prevention of bronchoconstriction and to reduce exacerbation risk in people with asthma aged 18 years and older. The medication is being studied in adolescents with asthma (12 to <18 years old) in the ACADIA Phase III trial and in patients in China in the BAIYUN Phase III trial.
Outside the US, Airsupra is approved in the United Arab Emirates, Kuwait, Bahrain, Qatar, and Oman.
Implications for Asthma Management
The BATURA results align with the latest global recommendations from the Global Initiative for Asthma, which recommends an anti-inflammatory reliever combination therapy taken as-needed as the preferred reliever therapy in mild asthma.
With asthma affecting as many as 262 million people worldwide, including over 25 million in the US, these findings represent a potential paradigm shift in how rescue therapy is approached, particularly for the majority of patients with mild asthma who have traditionally been treated with SABA alone despite the risk of severe exacerbations.
