Astrazeneca announces clinically meaningful BATURA phase III trial for the treatment of asthma

Astrazeneca announces their new positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, Airsupra, demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to albuterol in patients with mild asthma.

Note that BATURA builds upon the previous Phase III MANDALA and DENALI trials and in totality, the clinical programme demonstrates the benefit of as-needed Airsupra in reducing the risk of severe exacerbations across all asthma severities compared to albuterol alone. This BATURA data also aligns to the latest global recommendations from the Global Initiative for Asthma which recommends an anti-inflammatory reliever combination therapy taken as-needed as the preferred reliever therapy in mild asthma.

Craig LaForce, MD, Medical Director of North Carolina Clinical Research, said: “The unprecedented BATURA trial results provide an opportunity to change 50 years of clinical practice in asthma. For decades, millions of patients have relied on albuterol-only rescue treatment in asthma, leaving them unprotected against the increasing airway inflammation that could lead to a more serious attack. The results from the Airsupra BATURA trial add to a wide body of evidence on the value of the anti-inflammatory reliever rescue approach to not only provide immediate relief from symptoms, but also reduce inflammation to prevent future and more severe exacerbations for patients living with asthma across all severities.”

Tonya Winders, President of Global Allergy and Airways Patient Platform, said: “Patients who live with asthma are often at risk for unexpected exacerbations. Using an anti-inflammatory reliever therapy can transform every use of a rescue inhaler into an opportunity for early intervention to address the underlying inflammation of asthma, helping to prevent attacks and reduce exposure to systemic steroids. This is especially important for patients with mild asthma whose risk for severe exacerbations is often underestimated.”

Sharon Barr, Executive Vice-President and Head of BioPharmaceuticals R&D, AstraZeneca, said: “The exciting results from the BATURA trial, coupled with the findings from MANDALA and DENALI, clearly demonstrate the superiority of Airsupra over albuterol alone across all asthma severities. We hope these comprehensive results accelerate the use of anti-inflammatory rescue therapy as the preferred standard of care, in line with recommendations from the Global Initiative for Asthma.”

 

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Related Topics and Keywords

airsupra, asthma, AstraZeneca, BATURA Phase III trial