UK-based pharmaceutical company AstraZeneca has reported that its Phase IIIb BATURA trial of Airsupra (albuterol/budesonide) in patients with intermittent or mild persistent asthma met its primary endpoint.
The US-based trial assessed the efficacy and safety of inhaled albuterol/budesonide – 180 micrograms (mcg)/160mcg – as an as-needed rescue medication in response to symptoms, compared with as-needed albuterol (180mcg) over up to 12 months.
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The study enrolled patients aged 12 years and older, who were given as-needed, short-acting beta2-agonist (SABA) alone, or SABA with low-dose inhaled corticosteroid (ICS) or leukotriene receptor antagonist (LTRA) maintenance therapy.
Its primary endpoint was the time to the first severe asthma exacerbation, while secondary endpoints included the rate of severe exacerbations and total systemic corticosteroid use.
According to the latest results, the study met its primary endpoint with a statistically significant and clinically meaningful decline in severe exacerbation risk in subjects with intermittent or mild persistent asthma.
In addition, Airsupra’s safety and tolerability profile in the BATURA trial was in line with its established profile, with no new safety concerns reported.
AstraZeneca BioPharmaceuticals research and development executive vice-president Sharon Barr said: “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 is currently 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.
AstraZeneca and Arcus Biosciences recently began a clinical trial partnership to assess the combination of casdatifan (AB521) and volrustomig in patients with clear cell renal cell carcinoma (ccRCC).
Under the agreement, AstraZeneca will sponsor and operationalise a trial that aims to assess the safety and early efficacy of the combination therapy in patients with advanced ccRCC.
