The Journal of asthma : official journal of the Association for the Care of Asthma · 2025
Improved lung function with beclomethasone/formoterol versus beclomethasone alone in asthma: the FORCE2 study.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Weinstein Steven, Legramandi Lorenzo, Mathews Kusum S, Passineau Heather, Seregni Lucio, Gandini Giuliana, Cretarola Lorenza, Foti Martina, Skloot Gwen, Hernandez Gemzel
Аннотация
OBJECTIVE: This study aimed to confirm the efficacy and safety of the inhaled fixed-dose combination of beclomethasone dipropionate (BDP) plus formoterol fumarate (FF) vs. BDP in patients with asthma.
METHODS: After a two-week run-in period with asthma maintenance therapy switched to BDP via pressurized metered-dose inhaler (pMDI), eligible patients were randomized to BDP/FF or BDP, both via pMDI, for 12 wk. The primary objective was to demonstrate superiority of BDP/FF over BDP for change from baseline at Week 12 in area under the curve between 0 and 12 h post-dose (AUC0-12h) of forced expiratory volume in 1 sec (FEV1). The key secondary objective was to demonstrate superiority of BDP/FF over BDP for change from baseline at Week 12 in peak FEV1 within the first 3 h post-dose. Safety and tolerability were assessed as secondary endpoints.
RESULTS: Of 576 patients randomized to treatment, 543 completed the study (BDP/FF: 276/287 [96.2%]; BDP: 267/289 [92.4%]). The primary and the key secondary objectives were met, with BDP/FF vs. BDP adjusted mean differences of 104 (95% confidence interval 61, 148) mL and 124 (76, 173) mL for FEV1 AUC0-12h and peak FEV1 at Week 12, respectively (p < 0.001 for both). A similar proportion of patients experienced adverse events in the two treatment groups (26.9% vs. 26.4%), with most events mild or moderate in severity and not considered related to study drug.
CONCLUSIONS: The study met its aims, demonstrating the contribution of FF to BDP in lung function improvement, with both treatments being well tolerated.
UNLABELLED: ClinicalTrials.gov NCT05292586.
METHODS: After a two-week run-in period with asthma maintenance therapy switched to BDP via pressurized metered-dose inhaler (pMDI), eligible patients were randomized to BDP/FF or BDP, both via pMDI, for 12 wk. The primary objective was to demonstrate superiority of BDP/FF over BDP for change from baseline at Week 12 in area under the curve between 0 and 12 h post-dose (AUC0-12h) of forced expiratory volume in 1 sec (FEV1). The key secondary objective was to demonstrate superiority of BDP/FF over BDP for change from baseline at Week 12 in peak FEV1 within the first 3 h post-dose. Safety and tolerability were assessed as secondary endpoints.
RESULTS: Of 576 patients randomized to treatment, 543 completed the study (BDP/FF: 276/287 [96.2%]; BDP: 267/289 [92.4%]). The primary and the key secondary objectives were met, with BDP/FF vs. BDP adjusted mean differences of 104 (95% confidence interval 61, 148) mL and 124 (76, 173) mL for FEV1 AUC0-12h and peak FEV1 at Week 12, respectively (p < 0.001 for both). A similar proportion of patients experienced adverse events in the two treatment groups (26.9% vs. 26.4%), with most events mild or moderate in severity and not considered related to study drug.
CONCLUSIONS: The study met its aims, demonstrating the contribution of FF to BDP in lung function improvement, with both treatments being well tolerated.
UNLABELLED: ClinicalTrials.gov NCT05292586.