Effect of Montelukast on Leukotriene Sensitive Asthma Detected by LTD4 Bronchial Provocation Test
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- whether there was improvement in pre-challenge FEV1%
研究概览
简要总结
To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a specific sensitive to leukotriene population of asthma.
Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in leukotriene-sensitive group than leukotriene-insensitive group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 15-60 years, male or female.
- •Mild to moderate persistent asthma.
- •Mini AQLQ score ≤6 or ACQ score ≥
- •Giving written informed consent.
排除标准
- •Current smoker or quitted smoking ≤12 months.
- •Significant allergen exposure.
- •Respiratory tract infection within 2 weeks before or during the study.
- •Cardiovascular disease.
- •History of malignant disease within the preceding 5 years.
- •And/or concomitant pulmonary disease.
- •Pregnant or breast-feed period.
- •Use of leukotrienes receptor antagonist within 5 days
结局指标
主要结局
whether there was improvement in pre-challenge FEV1%
时间窗: from commencement of LTRA therapy to (7±2) days and (56±5) days
The primary outcome was a qualitative measure, with the results being expressed as either yes or no ('1' or '0' in Logistic model).A higher FEV1% is more suggestive of instability of asthma control.
次要结局
- whether there was improvement in post- treatment FENO(from commencement of LTRA therapy to (7±2) days and (56±5) days)
研究者
Xu Shi
Guangzhou Institute of Respiratory Disease
Guangzhou Institute of Respiratory Disease