BATURA Phase III trial results provide new evidence for Airsupra as standard of care for as-needed rescue treatment in asthma - AstraZeneca

Positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, Airsupra (albuterol/budesonide), demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to albuterol in patients with mild asthma. These data were published in the New England Journal of Medicine and presented at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, CA.

The trial measured as-needed Airsupra compared to as-needed albuterol, the most commonly used rescue medicine in the US. The BATURA trial demonstrated treatment with Airsupra significantly reduced the risk of a severe exacerbation by 47% (5.1%, 9.1%, hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.39, 0.73; p<0.001) when compared with albuterol alone. The overwhelming efficacy of Airsupra at a pre-specified interim analysis led to the early stop of the BATURA trial as recommended by the Independent Data Monitoring Committee.

BATURA builds upon the previous Phase III MANDALA and DENALI trials and in totality, the clinical programme demonstrates the benefit of as-needed Airsupra in reducing the risk of severe exacerbations across all asthma severities compared to albuterol alone. This BATURA data also aligns to 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. Mild asthma, affecting 50% to 70% of patients, is often assumed to be low-risk, yet can result in severe or even fatal exacerbations. People with mild asthma or infrequent asthma symptoms represent up to 30% of all reported asthma-related exacerbations and deaths.  

Craig LaForce, MD, Medical Director of North Carolina Clinical Research, said: “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 in asthma, leaving them unprotected against the increasing airway inflammation that could lead to a more serious attack. The results from the Airsupra BATURA trial add to a wide body of evidence on the value of the anti-inflammatory reliever rescue approach to not only provide immediate relief from symptoms, but also reduce inflammation to prevent future and more severe exacerbations for patients living with asthma across all severities.”  

Tonya Winders, President of Global Allergy and Airways Patient Platform (GAAPP), said: “Patients who live with asthma are often at risk for unexpected exacerbations. 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. This is especially important for patients with mild asthma whose risk for severe exacerbations is often underestimated."

Sharon Barr, Executive Vice-President and Head of BioPharmaceuticals R&D, AstraZeneca, said: “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.”

In a key secondary endpoint, adults and adolescents ages 12 and older receiving Airsupra had 63% lower exposure to total systemic corticosteroids (SCS) (p<0.001) over the treatment period compared with albuterol-alone, thereby reducing known risks from cumulative exposure to SCS. Similar reductions in all primary and secondary endpoints were seen in a prespecified subgroup of adult patients (≥18 years) on treatment.

SCS are commonly used to control inflammation in asthma, treatment of exacerbations, however as few as 1-3 short courses of SCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.  

Safety findings in the BATURA trial demonstrated the safety and tolerability of Airsupra was consistent with its well-established safety profile. There were no clinically meaningful differences in safety results between the Airsupra and albuterol groups.    

Airsupra is the first and only anti-inflammatory rescue medication approved in US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. The US approval was based on results from the MANDALA and DENALI Phase III trials.  Airsupra is also 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. Airsupra was developed by AstraZeneca and Avillion.  Outside of the US, Airsupra is approved in the United Arab Emirates, Kuwait, Bahrain, Qatar and Oman.

Phase IIIb BATURA trial
BATURA was a Phase IIIb, US, randomised, double-blind, parallel-group, event-driven trial, comparing the efficacy and safety of using inhaled albuterol/budesonide (180mcg/160mcg) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol (180mcg) for up to 12 months. Patients recruited were aged 12 years and over with intermittent or mild persistent asthma and must have been using as-needed albuterol, or as-needed SABA on a background of either low-dose inhaled corticosteroids (ICS) or leukotriene receptor antagonists (LTRA) maintenance therapy. Participants (n=2421) were randomised and treated 1:1 with Airsupra (n=1209) or albuterol as needed (n=1212) for 12-52 weeks. Two efficacy analysis populations were defined: the on-treatment population (data collected on-treatment before randomised treatment discontinuation or step-up maintenance therapy) and the intent-to-treat (ITT) population (all data, regardless of these events).

The primary efficacy endpoint was the time to first severe asthma exacerbation during the study period. Secondary endpoints included severe exacerbation rate and total systemic corticosteroid use. A severe exacerbation was defined as a worsening of symptoms resulting in three or more days of SCS use, an emergency department, urgent care visit or hospitalisation for asthma or death.

BATURA was a first-ever decentralised, patient-centric design allowed participants to accommodate trial-related activities around their daily lives and was intended to remove logistical barriers, thereby lowering participant burden and increasing efficiency and equitable access to the study.

AstraZeneca’s Collaboration with Avillion: In March 2018, AstraZeneca and Avillion signed an agreement to advance Airsupra through a global clinical development programme for the treatment of asthma. Under the terms of the agreement, Avillion became the trial sponsor responsible for executing and funding the global, multicentre clinical trial programme for Airsupra through NDA filing to a regulatory decision in the US. Following the successful approval of Airsupra, AstraZeneca is commercialising the medicine. AstraZeneca extended its agreement with Avillion in 2022 to undertake the BATURA Phase IIIb trial to further assess the role of Airsupra in reducing the risk of asthma exacerbations.

Citation: As-Needed Albuterol–Budesonide in Mild Asthma. Authors: Craig LaForce, M.D., Frank Albers, M.D., Ph.D. et al. Published May 19, 2025 New England Journal of Medicine.