AstraZeneca's Airsupra (albuterol/budesonide) has demonstrated a statistically significant and clinically meaningful reduction in the risk of severe asthma exacerbations among patients with intermittent or mild persistent asthma. These findings come from the Phase III BATURA trial, which was halted early by the Independent Data Monitoring Committee due to overwhelming efficacy observed during a pre-planned analysis.
The BATURA trial compared inhaled albuterol/budesonide (180 mcg/160 mcg) as an as-needed rescue medication to as-needed albuterol (180 mcg) over 12 months. The primary endpoint was the time to the first severe asthma exacerbation. Participants, aged 12 years and older, had intermittent or mild persistent asthma and were using a short-acting beta2-agonist (SABA) alone or with low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance therapy.
Clinically Meaningful Benefits
"People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control," said James Donohue, Emeritus Professor of Pulmonary Medicine, University of North Carolina, and chair of the Independent Data Monitoring Committee. "By focusing on patients with intermittent or mild persistent asthma, the strong BATURA trial results further demonstrate the clinically meaningful benefit of an anti-inflammatory rescue approach to reduce the risk of severe exacerbations by treating both symptoms and inflammation at the same time."
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, added, "The impressive BATURA trial results add to the body of evidence supporting Airsupra as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids."
Airsupra's Established Role
Airsupra is the first and only anti-inflammatory rescue medication approved in the US for as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. The FDA approved Airsupra in January 2023 based on the MANDALA and DENALI Phase III trials. In the MANDALA trial, Airsupra significantly reduced the risk of severe exacerbations by 27% compared to albuterol alone and was associated with reduced systemic corticosteroid use.
Safety and Tolerability
The safety and tolerability results from BATURA were consistent with Airsupra's established profile, and no new safety concerns were reported. The data will be shared with health authorities and presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26, 2024.
Asthma and Inflammation
Asthma, affecting as many as 262 million people worldwide, is a chronic inflammatory respiratory disease. Inflammation is central to asthma symptoms and exacerbations. While short-acting beta2-agonists (SABAs) like albuterol are commonly used as rescue medication, they do not address the underlying inflammation, leaving patients at risk of severe exacerbations. The Global Initiative for Asthma no longer recommends SABA monotherapy as the preferred rescue therapy.
Ongoing Studies
Airsupra is also being studied in adolescents with asthma (aged 12 to younger than 18 years old) in the ACADIA Phase III trial and in people with asthma in China in the BAIYUN Phase III trial.
