Comparison of Different Methodologies Assessing Airway Responsiveness and Investigation of Treatment Efficacy of Budesonide /Formoterol in Asthmatics
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- positive rate of BPT in each group
研究概览
简要总结
Bronchial asthma is a common chronic respiratory disease. Patients usually manifest variable symptoms (such as short of breath, chest tightness, cough, etc.) and variable airflow limitation and often associated with airway hyper-responsiveness and airway inflammation. About 1-18% of the global population suffered from the disease, causing huge economic burden for patients and countries. Airway reactivity measurement is an important way of diagnosis of asthma. Methacholine (Mch) bronchial provocation test(BPT) is the "gold standard" for the determination of airway reactivity, and other measuring methods(like adenosine monophosphate(AMP)-BPT, leukotriene D4(LTD4)-BPT, Astograph-BPT, etc.) were also brought into hot research fields. The investigators' purposes were to compare different kinds of methodologies(Mch,AMP,LTD4-BPT, Astograph-BPT) assessing airway responsiveness and to investigate treatment efficacy of budesonide /formoterol in asthmatics.
详细描述
This study composed of two parts, that were the diagnosing part and the treatment part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed Asthmatic patients aged from14 to 65 years；
- •Had a had a normal chest radiographic result；
- •Had a baseline spirometry with the forced expiratory volume in one second (FEV1) of not less than 60% predicted；
- •Without acute upper respiratory tract infection for the past 2 weeks
排除标准
- •Had a poor cooperation to the test or limited understandings;
- •Had a past confirmed history of respiratory disease other than bronchial asthma (COPD, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.）;
- •Pregnancy or breast-feeding women;
- •Taken related drugs before measurements（Leukotriene receptor antagonists (LTRA) for 5 days，oral glucocorticosteroid or anti-histamine for 3 days，oral xanthenes or long-acting bronchodilators for 2 days，inhaled corticosteroid or long-acting bronchodilator for a day , short-acting bronchodilator for 4 hours ）
研究组 & 干预措施
Methacholine diagnosing group
Methacholine bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
干预措施: methacholine (Drug)
Adenosine monophosphate diagnosing group
Adenosine monophosphate bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
干预措施: adenosine monophosphate (Drug)
Leukotriene D4 diagnosing group
Leukotriene D4 bronchial provocation test was performed by using Jaeger spirometry with Aerosol Provocation System
干预措施: leukotriene D4 (Drug)
Astograh diagnosing group
Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
干预措施: Astograph Jupiter-21 airway reaction testing apparatus (Device)
budesonide /formoterol treatment group
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three month
干预措施: budesonide /formoterol (Drug)
结局指标
主要结局
positive rate of BPT in each group
时间窗: 3months
comparing positive rates of BPT in experimental groups and control group
次要结局
- Fractional exhaled nitric oxide(FeNO)(3months)
- Forced expiratory volume at one second（FEV1）(3months)
- Provocative dosage causing a 20% fall in FEV1(PD20-FEV1)(3months)