| Popis: |
Objective: To assess the efficacy and safety of BFF MDI vs budesonide (BD) MDI, formoterol fumarate dihydrate (FF) MDI and Symbicort® Turbuhaler® (BUD/FORM dry powder inhaler [DPI]) in symptomatic subjects with moderate-to-very severe COPD (NCT02766608). Methods: In this Phase III, 24-week, randomized, double-blind, parallel-group study, subjects received BFF MDI (320/10μg or 160/10μg), FF MDI 10µg, BD MDI 320μg, or BUD/FORM DPI 400/12µg (all twice-daily). Results: 2,370 subjects were randomized and treated (60.5% male; mean post-bronchodilator FEV1, 52.9% predicted). For the co-primary endpoints, BFF MDI 320/10μg improved morning pre-dose trough FEV1 vs FF MDI (31mL, p Conclusions: Compared to FF MDI and BD MDI, BFF MDI 320/10μg resulted in clinically relevant and statistically significant improvements in lung function and exacerbation endpoints in symptomatic subjects with moderate-to-very severe COPD. |
