Budesonide/glycopyrronium/ formoterol fumarate dihydrate: A treatment option for inadequately controlled asthma

Budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) triple therapy led to significantly higher improvements in forced expiratory volume in 1 second (FEV1) and annualised severe exacerbation rates compared with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in patients with inadequately controlled asthma.

KALOS (NCT04609878) and LOGOS (NCT04609904) were identically designed, double-blind, double-dummy, randomised studies assessing twice-daily administration of two dose regimens of fixed-dose triple combination BGF, budesonide/formoterol fumarate dihydrate 320/10 µg via metered-dose inhaler (BFF), or currently available budesonide/formoterol fumarate dihydrate 320/9 µg metered-dose inhaler (BUD/FORM). Participants aged 12 to 80 years with uncontrolled asthma despite stable medium- to high-dose ICS/LABA. The primary endpoint was the change from baseline in morning pre-dose trough FEV1 over 24 weeks of treatment. The primary outcome for the pooled KALOS and LOGOS trials was the annualised severe exacerbation rate.

Prof. Alberto Papi (University of Ferrara, Italy) presented the results. BGF 320/28.8/10 µg compared with BFF or BUD/FORM led to significantly improved morning pre-dose trough FEV1, corresponding to a 76 mL least-squares mean increase (95% CI 57-94; P<0.001). Similarly, BGF 320/14.4/10 µg also led to a significant increase in FEV1, corresponding to a 65mL least-squares mean increase (95%CI 43-88; P<0.001) [1]. Both BGF regimens also resulted in significantly lower annualised severe exacerbation rates. The safety profile was comparable across all treatment groups, with similar rates of adverse events and serious adverse events.

“Single-inhaler triple therapy with BGF is superior to ICS/LABA therapy, providing greater improvements in lung function and fewer severe exacerbations in participants with inadequately controlled asthma”, concluded Prof. Papi.

1. Papi A, et al. Budesonide/glycopyrronium/formoterol fumarate dihydrate triple therapy for inadequately-controlled asthma: KALOS and LOGOS study results. ERS Congress, 27 September–1 October 2025, Amsterdam, the Netherlands.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 1 October 20253 November 2025