A 12-week, Randomized, Parallel-group, Phase III Study Comparing the Efficacy of Once-daily Budesonide/formoterol Turbuhaler (160/4.5 μg/d) with Twice-daily Budesonide (400 μg/d) During the Step-down Period in Well-controlled Asthma.

Abstract

Budesonide/formoterol fumarate (BUD/FF) is recommended in the stepwise management of uncontrolled asthma, but data on a once-daily dose of this medication in a step-down period are lacking. We aimed to compare BUD/FF and BUD in terms of the changes in asthma control scores and lung functions. This 12-week, randomized, parallel-group, single-center, open-label study was conducted in well-controlled asthmatic patients receiving twice-daily BUD/FF (160/4.5 μg 2 inhalations) randomized into once-daily BUD/FF (160/4.5 μg 1 inhalation) or twice-daily BUD (200 μg 2 inhalations). At week 12, the medians of Asthma Control Test (ACT) were 23 (interquartile range [IQR]: 22-24) in the BUD/FF group and 23 (IQR: 22-24.5) in the BUD group, while the medians of Asthma Control Questionnaire (ACQ) were 0.43 (IQR: 0.29-0.82) in the BUD/FF group and 0.57 (IQR: 0.43-0.93) in the BUD group. No statistically significant difference was observed in either ACT (p=0.673) or ACQ (p=0.295) between the treatments. The ACT scores significantly decreased from baseline to week 12 in both treatments. Peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) also had no statistically significant differences between treatments. PEF in the BUD/FF group and FEV1 in both treatments significantly decreased from baseline to week 12. Compared to twice-daily BUD, once-daily BUD/FF provides equivalent asthma control scores and lung function during the step-down period after switching from twice-daily doses of BUD/FF in well-controlled asthma.