E-ISSN 2149-2530
Original Article
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
1 Division of Pulmonology, Department of Medicine, Hat Yai Medical Education Center, Hat Yai Hospital, Songkhla, Thailand  
2 Department of Nursing, Hat Yai Hospital, Songkhla, Thailand  
Turk Thorac J 2018; 19: 66-72
DOI: 10.5152/TurkThoracJ.2018.17072
Key Words: Asthma, step down, budesonide, formoterol
Abstract

 

OBJECTIVES: 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.

 

MATERIAL AND METHODS: 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).

 

RESULTS: 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=0.67) or ACQ (p=0.30) 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.

 

CONCLUSION: 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.

 

Cite this article as: Nakwan N, Perkleang T, Tamsawaii T, et al. 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 Giona Easyhaler (400 μg/d) During the Step-down Period in Well-Controlled Asthma. Turk Thorac J 2018: 19; 66-72.

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