AstraZeneca’s Airsupra Significantly Reduces Risk of Severe Exacerbations in Patients with Asthma
The company will be presenting the full BATURA study data as a late-breaker oral presentation at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting.
Positive results have been announced from a phase 3b trial evaluating the efficacy and safety of albuterol/budesonide (Airsupra) as an as-needed rescue medication in response to symptoms in patients aged 12 years or older with intermittent or mild persistent asthma, AstraZeneca said in a release.1 The trial compared albuterol/budesonide to albuterol and was done in collaboration with Avillion Life Sciences.
AstraZeneca’s Airsupra Significantly Reduces Risk of Severe Exacerbations in Patients with Asthma / Sundry Photography - stock.adobe.com
Data from the BATURA study (NCT05505734) showed that albuterol/budesonide met its primary efficacy endpoint of time to first severe asthma exacerbation. Key secondary endpoints assessed in the study included annualized rate of severe asthma exacerbations, total amount per patient of systemic glucocorticoid exposure, total days of systemic glucocorticoid exposure, and number of patients with serious adverse events and adverse events.
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“People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control,” James Donohue, emeritus professor of Pulmonary Medicine at the University of North Carolina, said in a release.1 “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.”
BATURA is a randomized, multicenter, double-blind, parallel-group, event-driven phase 3b study comparing the efficacy and safety of using inhaled albuterol/budesonide (180mcg/160mcg) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol (180mcg) for up to 12 months.
The study cohort included over 2500 patients aged 12 years or older with intermittent or mild persistent asthma who are currently taking short-acting beta2-agonist alone, low-dose inhaled corticosteroid maintenance therapy, or leukotriene receptor antagonist maintenance therapy. Patients from over 40 centers located in the United States randomly received either albuterol or albuterol/budesonide.
The study showed albuterol/budesonide demonstrated 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 safety and tolerability of the therapy was consistent with its established profile and there were no new safety concerns reported during the study.
AstraZeneca said in the release that it intends to share the new data with health authorities. The company will also be presenting the full data as a late-breaker oral presentation at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26, 2024.
“We are thrilled with this positive outcome from the BATURA trial, which has generated truly outstanding clinical results,” Allison Jeynes, MD, CEO of Avillion Life Sciences, said in a release.2 “It is extremely gratifying to see that the hard work and dedication put into our long-term collaboration with AstraZeneca around Airsupra has proved so successful over such an extensive global clinical development program. Our work together in bringing this new therapy to asthma patients really highlights the strong value proposition of our clinical co-development model as well as the clinical and operational excellence that our highly committed international team brings.”
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