NCT00557700已完成2 期
Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The mean change in the provocative concentration of neurokinin-A (NKA) causing a 20% fall in the forced expiratory volume in one second (PC20NKA), as a measure of indirect airway hyperresponsiveness
研究概览
简要总结
This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Male or female, at least 18 years old
- •Documented medical history of asthma (diagnosis at least 6 months ago)
- •Non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years)
- •Able to conduct a technically acceptable spirometry, methacholine and neurokinin-A provocation test.
- •At visit 1: PC20 methacholine ≤ 8 mg/ml AND ≤ 3.3x10-7 mol/ml for the neurokinin-A provocation test.
- •At visit 1: forced expiratory value in one second >= 80% of the predicted value.
- •Female subjects may not get pregnant and should be using adequate contraception.
排除标准
- •Airway infection within 6 weeks prior to first study visit.
- •Other respiratory diseases (eg COPD, lung cancer, etc.)
- •Participating in another clinical trial.
- •Clinically relevant systemic diseases, other than asthma.
- •Clinically significant laboratory deviations.
- •Alcohol or drug abuse.
- •Female subjects who are lactating.
研究组 & 干预措施
2
Placebo Comparator
Administration of placebo
干预措施: Administration of placebo (Drug)
1
Experimental
Administration of inhaled tiotropium bromide
干预措施: Administration of inhaled tiotropium bromide (Drug)
结局指标
主要结局
The mean change in the provocative concentration of neurokinin-A (NKA) causing a 20% fall in the forced expiratory volume in one second (PC20NKA), as a measure of indirect airway hyperresponsiveness
时间窗: After 20 days
次要结局
- The change in the one-second-value in the forced vital capacity(After 20 days)
- The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness(After 20 days)
研究者
研究点 (2)
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