ERJ open research · 2026
Budesonide/formoterol fumarate dihydrate versus budesonide with a novel suspension technology for uncontrolled asthma: phase 3 VATHOS study.
СтатьяНазвание и аннотация: Перевод в очереди
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Jackson David J, Wise Robert A, Papi Alberto, Lugogo Njira, Chen Ruchong, Chami Hassan, Armengol Clara, Daoud Sami Z, Nauclér Emma, Bowen Karin, Megally Ayman, Sobande Olami, Patel Mehul
Аннотация
BACKGROUND: Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy is important in asthma. The phase 3 VATHOS study (ClinicalTrials.gov: NCT05202262) assessed the efficacy and safety of budesonide/formoterol fumarate dihydrate (BFF) via metered-dose inhaler (MDI) using Aerosphere co-suspension technology (BFFA) versus either budesonide (BD) via MDI using Aerosphere or BFF via dry-powder inhaler (BFFDPI).
METHODS: Participants (age 12-80 years; n=645) with inadequately controlled asthma on medium-dose ICS or ICS/LABA were randomised 1:2:2:2 to twice-daily BFF 160/10 μg (BFFA 160), BFF 320/10 μg (BFFA 320), BD 320 μg (BD 320) or open-label BFFDPI 320/9 μg, respectively. End-points included change from baseline in forced expiratory volume in 1 s area under the curve from 0 to 3 h (FEV1 AUC0-3) at 24 weeks (primary), and morning pre-dose trough FEV1 at 24 weeks, onset of action (day 1 change in FEV1, 5 min post-dose) and severe exacerbation rates (secondary). Adverse events (AEs) were recorded.
RESULTS: BFFA 320 demonstrated superior lung function versus BD 320 at week 24 (mean change from baseline in FEV1 AUC0-3: 173 (95% CI 112-233) mL (p<0.0001); trough FEV1: 61 (95% CI 1-120) mL (p=0.0447); onset of action: 144 (95% CI 110-177) mL (p<0.0001)). Severe exacerbation rates were similar between BFFA 320 and BD 320 (rate ratio 1.02 (95% CI 0.61-1.70); p=0.9473). AEs were similar across treatments (BFFA 320, 50.3%; BFFA 160, 50.0%; BD 320, 38.1%; BFFDPI, 45.7%). BFFA 320 showed non-inferiority to BFFDPI in lung function.
CONCLUSION: These findings support the use of BFFA 320 with co-suspension delivery technology in people with inadequately controlled asthma on medium-dose ICS or ICS/LABA.
METHODS: Participants (age 12-80 years; n=645) with inadequately controlled asthma on medium-dose ICS or ICS/LABA were randomised 1:2:2:2 to twice-daily BFF 160/10 μg (BFFA 160), BFF 320/10 μg (BFFA 320), BD 320 μg (BD 320) or open-label BFFDPI 320/9 μg, respectively. End-points included change from baseline in forced expiratory volume in 1 s area under the curve from 0 to 3 h (FEV1 AUC0-3) at 24 weeks (primary), and morning pre-dose trough FEV1 at 24 weeks, onset of action (day 1 change in FEV1, 5 min post-dose) and severe exacerbation rates (secondary). Adverse events (AEs) were recorded.
RESULTS: BFFA 320 demonstrated superior lung function versus BD 320 at week 24 (mean change from baseline in FEV1 AUC0-3: 173 (95% CI 112-233) mL (p<0.0001); trough FEV1: 61 (95% CI 1-120) mL (p=0.0447); onset of action: 144 (95% CI 110-177) mL (p<0.0001)). Severe exacerbation rates were similar between BFFA 320 and BD 320 (rate ratio 1.02 (95% CI 0.61-1.70); p=0.9473). AEs were similar across treatments (BFFA 320, 50.3%; BFFA 160, 50.0%; BD 320, 38.1%; BFFDPI, 45.7%). BFFA 320 showed non-inferiority to BFFDPI in lung function.
CONCLUSION: These findings support the use of BFFA 320 with co-suspension delivery technology in people with inadequately controlled asthma on medium-dose ICS or ICS/LABA.