A new triple-therapy inhaler combining budesonide, glycopyrronium and formoterol (BGF) has demonstrated meaningful improvements in lung function and reductions in severe asthma attacks among patients whose symptoms remain uncontrolled despite standard treatment.
According to results from two large, international, phase 3 trials, a broad population of patients whose asthma remained uncontrolled on standard inhaled corticosteroid (ICS) with a long-acting beta-agonist ICS–LABA therapy experienced the benefit. Additionally, researchers said they observed the benefits regardless of recent exacerbation history and suggested BGF may be an effective escalation option even without a recent asthma flare. Their findings were detailed in the paper, “Budesonide–Glycopyrronium–Formoterol Fumarate Dihydrate in Uncontrolled Asthma (KALOS and LOGOS): Twin Multicenter, Double-Blind, Double-Dummy, Parallel-Group, Randomized, Phase 3 Trials,” published in The Lancet Respiratory Medicine.
The KALOS and LOGOS studies — spanning more than 700 clinical sites across 35 countries and involving more than 8,800 participants, with 4,311 receiving treatments — tested the effectiveness of the triple therapy against two versions of the commonly used dual-therapy budesonide–formoterol inhalers (BFFA and Symbicort/BFFS).
Participants aged 12 to 80 who continued to experience symptoms despite daily medium- or high-dose ICS-LABA therapy were randomly assigned to one of four treatment arms.
Across both trials, the BGF 28.8 µg dose consistently outperformed all dual-therapy comparators. Key findings include:
- BGF delivered significantly greater improvements in trough FEV₁, a key measure of lung capacity.
- BGF showed superior gains in FEV₁ AUC0-3, an indicator of how well air moves through the lungs in the hours after dosing.
- These gains were statistically significant in all regulatory comparisons, with improvements ranging from 76 mL to 90 mL across 24 weeks.
Beyond lung function, BGF also reduced serious asthma flare-ups. The BGF 28.8 µg dose lowered the annual rate of severe exacerbations by 14% compared with pooled dual-therapy inhalers and by 18% compared with Symbicort alone. The study’s authors said these reductions are clinically meaningful for patients who suffer frequent exacerbations, which often lead to emergency care or hospitalization.
Across all treatment groups, adverse event rates were similar: 53% of patients on BGF 28.8 µg reported side effects, compared with:
- 60% on BGF 14.4 µg
- 55% on BFFA
- 58% on Symbicort (BFFS)
No deaths were deemed related to the study treatments, and no unexpected safety signals emerged.
Researchers noted that BGF could become an important option for people with asthma who remain inadequately controlled even on high-dose ICS–LABA therapy and said it could position the combination therapy as a promising next step in asthma care.
