AstraZeneca’s inhaled anti-inflammatory rescue medication demonstrated significant benefit compared to albuterol in a phase IIIb trial.


RT’s Three Key Takeaways:

  1. Airsupra Reduces Severe Asthma Exacerbations: The BATURA phase IIIb trial demonstrated that AstraZeneca’s Airsupra, used as an as-needed rescue medication, significantly reduced the risk of severe asthma exacerbations compared to albuterol alone.
  2. Effective Across Asthma Severity Levels: The trial included patients with intermittent or mild persistent asthma, showing that Airsupra benefits those at varying levels of asthma severity, even those on maintenance therapies.
  3. Safety and Efficacy Confirmed: The safety profile of Airsupra remained consistent with previous studies, and no new safety concerns were reported.

Positive results from the BATURA phase IIIb trial showed AstraZeneca’s Airsupra (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol.

The trial included patients with intermittent or mild persistent asthma, including those on short-acting beta2-agonist alone, low-dose inhaled corticosteroid maintenance therapy, or leukotriene receptor antagonist maintenance therapy.

“People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. 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,” says James Donohue, MD, emeritus professor of pulmonary medicine, University of North Carolina, and chair of the Independent Data Monitoring Committee, in a release. 

The safety and tolerability of Airsupra in the BATURA trial was consistent with its established profile and no new safety concerns were reported. 

The data will be shared with health authorities and will be presented as a late-breaker oral presentation at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting on Oct 26.

“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,” says Sharon Barr, executive vice president, biopharmaceuticals R&D, AstraZeneca, in a release.

Approval and Ongoing Studies

Airsupra 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. 

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 is being developed by AstraZeneca and Avillion.

Photo caption: Airsupra

Photo credit: AstraZeneca/file photo