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- W2022145213 abstract "Asthma management focuses on achieving and maintaining asthma control. Few studies have assessed whether complete and sustained asthma control is maintained in clinical practice after stepping-across ICS/LABA fixed combinations. Aim of this double-blind, double-dummy, randomized, parallel group, controlled study was to demonstrate clinical equivalence between equipotent doses of extrafine beclometasone/formoterol (BDP/F) pMDI and fluticasone/salmeterol (FP/S) Diskus® in maintaining lung function and asthma control. A total of 416 asthmatic patients already controlled with FP/S 500/100 μg/day (Diskus®, pMDI or separate inhalers) were randomized to a 12-week treatment with extrafine BDP/F 400/24 μg/day pMDI or FP/S 500/100 μg/day Diskus®. Pre-dose 1-s forced expiratory volume (FEV1) was the primary efficacy variable; secondary variables included asthma control questionnaire (ACQ-7) and FEV10-1 h area under the curve (FEV1AUC0–1h). Safety was assessed through adverse events monitoring and vital signs. After 12 weeks of treatment, pre-dose FEV1 did not differ between treatments (difference between means 0.01 L; 95% CI –0.03–0.06 L) with no significant changes from baseline in both groups (p = 0.726 and p = 0.783 in BDF/F arm and FP/S, respectively). ACQ-7 score showed that control was maintained after stepping-across to extrafine BDP/F. FEV1AUC0–1h was significantly higher in BDP/F arm at the beginning (p = 0.004) and at the end of the 12-week treatment period (p = 0.019). No safety issues were reported in both groups. Patients previously controlled with FP/S in any device formulation can effectively step-across to extrafine BDP/F pMDI, maintaining lung function and asthma control with a 5-min onset of action." @default.
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- W2022145213 date "2013-10-01" @default.
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- W2022145213 title "Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination" @default.
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- W2022145213 doi "https://doi.org/10.1016/j.pupt.2013.01.011" @default.
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