NCT01951898Unknown2 期
Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Montelukast will up-regulate airway regulatory T cell in the patients with asthma
研究概览
简要总结
Montelukast is one of anti-inflammatory agents and a good controller for the patients with asthma. The hypothesis of the study is that the Montelukast will have airway anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild status
- •stable status
- •nonsmoker
- •Positive of airway hyperresponsiveness (Methacholine-PC20<16mg/mL)
排除标准
- •taken other asthmatic medications such as oral, injective, and inhaled steroids, leukotriene antagonists, oral, inhaled, and transdermal beta-agonists, theophylline, anti-histamine agents, anti-IgE antibodies and long acting muscarinic receptor antagonists.
- •respiratory tract infections within 4wks
- •moderate to severe other organ disorders
- •active malignancies
- •past histories of side effects of leukotriene antagonists
- •psychological disorders
- •pregnancy or nursing
研究组 & 干预措施
Montelukast
Active Comparator
干预措施: Montelukast (Drug)
Vitamin B6
Sham Comparator
干预措施: Montelukast (Drug)
结局指标
主要结局
Montelukast will up-regulate airway regulatory T cell in the patients with asthma
时间窗: 4wks of treatment period
次要结局
- Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma(4wks of treatment periods)
研究者
研究点 (1)
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