AstraZeneca and Avillion Life Sciences have announced positive results from the Phase 3b BATURA trial, evaluating Airsupra (albuterol/budesonide) in patients with intermittent or mild persistent asthma. The trial demonstrated a statistically significant reduction in the risk of severe asthma exacerbations when Airsupra was used as an as-needed rescue medication compared to albuterol alone. The Independent Data Monitoring Committee recommended the trial be stopped early due to the overwhelming efficacy observed at a pre-planned analysis.
BATURA Trial Details
The BATURA trial was a Phase 3b, randomized, double-blind, parallel-group, event-driven study conducted in the US. It compared the efficacy and safety of inhaled albuterol/budesonide (180mcg/160mcg) as an as-needed rescue medication to as-needed albuterol (180mcg) over a 12-month period. The study enrolled patients aged 12 years and older with intermittent or mild persistent asthma. Participants were using as-needed short-acting beta2-agonist (SABA) alone, or SABA with low-dose inhaled corticosteroid (ICS) or leukotriene receptor antagonist (LTRA) maintenance therapy.
The primary efficacy endpoint was the time to the first severe asthma exacerbation during the study period. Secondary endpoints included the rate of severe exacerbations and total systemic corticosteroid use.
Clinical Significance
"People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control," said James Donohue of the University of North Carolina, who chairs the BATURA 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."
Airsupra: A Novel Approach to Asthma Rescue
Airsupra (albuterol/budesonide) is the first and only anti-inflammatory rescue medication approved in the 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. It combines albuterol, a SABA, with budesonide, an ICS, in a single inhaler. This approach addresses both the immediate symptoms and the underlying inflammation associated with asthma.
Asthma Burden and Current Treatment Landscape
Asthma affects as many as 262 million people worldwide, including over 25 million in the US. Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency. There are an estimated 136 million asthma exacerbations globally per year, including more than 10 million in the US. Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine; however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations.
Future Directions
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. The data from the BATURA trial will be shared with health authorities and presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting.
