AstraZeneca Reports Results of PT027 (albuterol and budesonide) in P-III MANDALA and DENALI Trials for the Treatment of Asthma
Shots:
- The P-III MANDALA & DENALI trial evaluates the efficacy & safety of PT027 (180/160mcg & 180/80mcg doses) vs albuterol & albuterol and budesonide aged ≥4yrs. in 3132 & 1001 patients with asthma
- Both trials met its 1EPs i.e.- reductions in risk of severe exacerbations in the MANDALA trial- improvement in lung function as measured by FEV1 in DENALI trials- safety & tolerability in both trials were consistent with the known profiles of the components
- PT027 is a fixed-dose combination of albuterol- SABA- budesonide & an inhaled ICS. The therapy is being developed by AstraZeneca and Avillion
| Ref: AstraZeneca | Image: PharmaLive
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