A 12-week, Randomized, Parallel-group, Phase III Study Comparing the Efficacy of Once-daily Budesonide/Formoterol Turbuhaler (160/4.5 μg/d) and Twice-daily Budesonide Giona Easyhaler (400 μg/d) During Step-down Period in Well Controlled Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Change from baseline in Asthma Control Questionnaire (ACQ) score
研究概览
简要总结
This study will evaluate the efficacy of Once-daily Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient.
详细描述
The study will measure the efficacy of once daily low dose ICS/ LABA in well controlled asthmatic patient comparing with low dose ICS in step down circumstance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthmatic patients who have well controlled asthma at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily
- •Age more than 18 year-old
- •Patients who able to do spirometry without contraindication
- •History smoking less than 10 pack-years
排除标准
- •History of using systemic steroid previous 4 week and respiratory infection
- •History of pulmonary tuberculosis with residual lung lesion by chest radiograph
- •recent serious medical condition such as myocardial infarction, stroke, pneumonia etc.
研究组 & 干预措施
Once-daily budesonide/formoterol (160/4.5 μg/d)
once-daily budesonide/formoterol (160/4.5 μg/d)
干预措施: Budesonide/formoterol (160/4.5 μg/d) (Drug)
Twice-daily Budesonide (200μg)
twice-daily Budesonide (400μg/d)
干预措施: Budesonide (400μg/d) (Drug)
结局指标
主要结局
Change from baseline in Asthma Control Questionnaire (ACQ) score
时间窗: Baseline and week 12
Asthma Control Questionnaire (ACQ) that is 6 items of self-administered and 1 item of FEV1%. It has 7-point scale (=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Change from baseline in Asthma Controlled Test (ACT) score
时间窗: Baseline, week 4, week 8 and week 12
1. Asthma Controlled Test (ACT); grouped in five domains; frequency of shortness of breath, general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma
次要结局
- Change from baseline in Peak expiratory flow (PEF)(Baseline, week 4, week 8 and week 12)
- Change from baseline in Forced Expiratory Volume in One Second (FEV1)(Baseline and week 12)
- Percentage of participants who were categorized from asthma controlled assessment following GINA guideline(Baseline, week 4, week 8 and week 12)
研究者
Narongwit Nakwan
Head of Pulmonology
Hat Yai Medical Education Center