KALOS and LOGOS Data: Lung Function and Exacerbation Findings

AstraZeneca reports that a pooled Phase III analysis in uncontrolled asthma found lung function improvements with single-inhaler triple therapy Breztri (budesonide/glycopyrronium/formoterol) compared with combined inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) groups.

The findings come from a pre-specified pooled analysis of primary endpoints across the Phase III KALOS and LOGOS trials in patients characterized as having uncontrolled asthma. In the update, comparisons were made against dual therapy—defined as the ICS/LABA treatment groups combined—over a 24-week efficacy timeframe.

For lung function, AstraZeneca reports that, in the pooled analysis of KALOS and LOGOS, the triple combination improved morning pre-dose trough FEV1 by 76 mL (95% CI 57–94; unadjusted p<0.001) over 24 weeks versus the ICS/LABA treatment groups combined. The company also reports an improvement in FEV1 AUC0–3 of 90 mL (95% CI 72–108; unadjusted p<0.001) over the same period versus the combined ICS/LABA groups.

The pooled analysis showed reductions in the annualised rate of severe asthma exacerbations with the triple combination versus ICS/LABA medicines. On safety, AstraZeneca reports that no new safety or tolerability signals were identified for the triple combination in KALOS or LOGOS.