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AZN : Phase III Trial Shows PT027 Reduces Risk Of Severe Exacerbation By 27% In Asthma Patients

AstraZeneca Plc. (AZN.L,AZN) said MANDALA Phase III trial results showed that PT027 (albuterol/budesonide) at two different strengths of budesonide, an inhaled corticosteroid or ICS, used as an as-needed rescue medicine, demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma.

PT027 is a potential first-in-class inhaled, fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide in the US. It is being developed by AstraZeneca and Avillion.

Compared with albuterol rescue, PT027 at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% in adults and adolescents. In the trial, patients were randomized to receive PT027 or albuterol rescue, on top of their usually prescribed maintenance ICS, with or without additional controller medicines.

In secondary endpoints, PT027 (180mcg albuterol/160mcg budesonide) demonstrated a 33% reduction in mean annualized total systemic corticosteroid exposure and a 24% reduction in annualized severe exacerbation rate. A numerically higher odds of patients experiencing an improvement in symptom control and quality of life was also observed after 24 weeks of treatment with PT027 compared to albuterol rescue.

In the MANDALA trial, PT027 at a lower budesonide dose (180mcg albuterol/80mcg budesonide), also demonstrated a statistically significant reduction of 17% in the risk of severe exacerbation versus albuterol rescue, when used as an as-needed rescue medicine in adults, adolescents, and children aged 4-11 years.

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