A Pilot Study of Efficacy of As-needed Budesonide/Formoterol Turbuhaler During Stepping Down Period From Step-3 in Adult Patients With Adequately Controlled Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Time to First moderate/severe asthma exacarbation rate
研究概览
简要总结
This study will evaluate the efficacy of as-needed Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient comparing with standard maintenance therapy in step-2 management in asthma guildeline which is low dose inhaled corticosteroid.
详细描述
The study will measure the efficacy of as-needed 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed as asthma at least 6 months.
- •Patients who have well controlled asthma by ACT > 23 and ACQ-7 < 0.75 at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily
- •Patient who not be taking oral bronchodilator such as montelukast, theophylline, doxophylline but accept for taking anti histamine and intranasal steroid.
- •Patients who able to do spirometry without contraindication.
排除标准
- •History of using systemic steroid previous 12 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.
- •History smoking less than 10 pack-years or be smoking
- •History of asthma exacabation previous 12 week
研究组 & 干预措施
As-needed Budesonide/Formoterol
As-needed Budesonide/Formoterol (160/4.5 ug)
干预措施: Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder (Drug)
Budesonide
Budesonide (200 ug) twice daily
干预措施: Budesonide 200Mcg Inhalation Powder (Drug)
结局指标
主要结局
Time to First moderate/severe asthma exacarbation rate
时间窗: Patients will be followed for first moderate/severe asthma exacerbation rate (an estimated average duration of 24-48 weeks)
Duration after randomisation until the patients will develop asthma exacerbation.
Time to First loss of asthma controlled
时间窗: Patients will be followed for loss of asthma controlled (an estimated average duration of 24-48 weeks)
Duration after randomisation until the patients will have a loss of asthma control evaluating by Asthma Controlled Test (ACT)
The ratio of asthma controlled to total number of participants
时间窗: The ratio of asthma controlled to total number of participants at week 24th-48th.
The ratio of participants who will be classified for asthma controlled to total number of participants by ACT score
Time to First moderate/severe asthma exacerbation rate or loss of asthma controlled
时间窗: Patients will be followed for first moderate/severe asthma exacerbation rate or loss of asthma controlled (an estimated average duration of 24-48 weeks)
Duration after the patients who has been randomised to developed asthma exacerbation or loss of asthma control that evaluation by Asthma Controlled Test (ACT)
次要结局
- Change in lung function: Peak expiratory flow(24-48 weeks.)
- Change in lung function: FEV1%predicted(24-48 weeks.)
- Change in blood eosinophil count(24-48 weeks.)
- Change in FENO(48 weeks.)
- Mean dose of inhaled steroid(24-48 weeks.)
研究者
Narongwit Nakwan
Head of Pulmonology
Hat Yai Medical Education Center