Improved lung function with beclomethasone/formoterol versus beclomethasone alone in asthma: the FORCE2 study.

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.