Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials.

Summary

In two parallel phase 3 RCTs, fixed-dose budesonide–glycopyrronium–formoterol improved lung function and reduced severe exacerbations versus dual therapy in patients inadequately controlled on medium/high-dose ICS–LABA. Benefits were observed irrespective of recent exacerbation history, supporting earlier escalation to triple inhaler therapy.

Key Findings

• BGF improved lung function and reduced severe exacerbations versus ICS–LABA (dual therapy).
• Efficacy was consistent regardless of recent exacerbation history.
• Findings applied across a broad 12–80-year-old asthma population inadequately controlled on medium/high-dose ICS–LABA.

Clinical Implications

Consider escalation to budesonide–glycopyrronium–formoterol in patients with persistent symptoms or risk despite medium/high-dose ICS–LABA, even without a very recent exacerbation, while monitoring individual response and safety.

Limitations

• Abstract does not provide numerical effect sizes by subgroup or dose
• Comparisons to alternative add-on strategies (e.g., tiotropium add-on) were not detailed

Future Directions

Head-to-head trials versus other step-up strategies and longer-term safety/effectiveness studies across diverse phenotypes will refine patient selection for triple therapy.