Results From Phase III KALOS And LOGOS Trials Published In Lancet Respiratory Medicine Shows AstraZeneca's BREZTRI Aerosphere Demonstrated Significant Phase III Gains In Uncontrolled Asthma Vs. ICS/LABA Standards
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Full results from the positive Phase III KALOS and LOGOS trials published in The Lancet Respiratory Medicine showed AstraZeneca's BREZTRIAerosphere(budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) demonstrated statistically significant and clinically meaningful improvements in patients with uncontrolled asthma compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines: Symbicort (budesonide/formoterol fumarate or BFF, a standard therapeutic option), PT009 (BFF in an Aerosphere formulation) and the Symbicort and PT009 treatment groups combined.1 BREZTRIis a single-inhaler, fixed-dose triple-combination of ICS/LABA and a long-acting muscarinic antagonist (LAMA).
In a pre-specified pooled analysis of the primary endpoints across the KALOS and LOGOS trials, BREZTRIimproved lung function by 76mL (95% CI 57-94 mL, unadjusted p<0.001, as measured by morning pre-dose trough FEV1 over 24 weeks) and 90mL (95% CI 72-108 mL, unadjusted p<0.001, as measured by FEV1 AUC0-3 over 24 weeks) versus dual therapy (the ICS/LABA treatment groups combined).1
In the pooled analysis of KALOS and LOGOS, BREZTRIalso demonstrated clinically meaningful reductions in the annualized rate of severe asthma exacerbations versus ICS/LABA medicines in patients with or without a recent asthma exacerbation. Full results can be found in The Lancet Respiratory Medicine.
