AstraZeneca Reports Results of PT027 in a P-III (MANDALA) Trial as a Fixed-Dose Combination of Albuterol and Budesonide for Asthma
Shots:
- The P-III (MANDALA) trial evaluates PT027 (180/160mcg & 180/80mcg doses) vs albuterol in a ratio (1:1:1) in 3132 patients aged 4–11yrs. with asthma
- The results showed that patients treated with PT027 at 180mcg albuterol/160mcg budesonide dose reduced the risk of a sev. exacerbation by 27%. In 2EPs, 33% reduction in mean annualized total systemic corticosteroid exposure & 24% in annualized severe exacerbation rate, improvement in symptom control & QoL @24wks., AEs were similar & consistent with known safety profiles
- Patients at a lower budesonide dose (180mcg albuterol/80mcg budesonide) showed a reduction of 17% in the risk of sev. exacerbation. The results were published in NEJM & presented at ATS 2022
Ref: Businesswire | Image: AstraZeneca
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