AstraZeneca’s Airsupra Asthma Trial Halted Early Due to Overwhelming Efficacy, Paving Way for Regulatory Submission

Early Trial Stop:
AstraZeneca's Phase IIIb BATURA trial for Airsupra, a combination of albuterol and budesonide, was stopped early due to "overwhelming efficacy" in treating asthma.

Trial Results:
The trial demonstrated a statistically significant and clinically meaningful reduction in the risk of severe asthma exacerbations when used as an as-needed rescue medication compared to as-needed albuterol.

Patient Population:
The trial included patients aged 12 years and older with intermittent or mild persistent asthma, who were given as-needed short-acting beta2-agonist (SABA) alone or with low-dose inhaled corticosteroid (ICS) or leukotriene receptor antagonist (LTRA) maintenance therapy.

Regulatory Path:
AstraZeneca plans to submit the data to health authorities, further supporting Airsupra as a first-in-class rescue treatment for asthma.

Previous Approval:
Airsupra is already approved in the US for as-needed treatment or prevention of bronchoconstriction and to reduce exacerbation risks in individuals aged 18 years and older with asthma.

Clinical Significance:
The trial results highlight the benefit of an anti-inflammatory rescue approach in reducing the risk of severe exacerbations by treating both symptoms and inflammation simultaneously.