NCT01209533已完成早期 1 期
Inhaled Iloprost in Mild Asthma
适应症
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- PD20FEV1 methacholine
研究概览
简要总结
The purpose of the study is to determine if inhaled iloprost given four times daily can improve symptoms and lung function in adults with mild asthma.
详细描述
Animal studies have suggested that prostacyclin may downregulate allergic inflammation, thus providing the scientific basis for trials of inhaled prostacyclin agonists such as iloprost for the treatment of asthma. This study will examine the tolerability of four times daily iloprost on asthma symptoms and pulmonary function over a two week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of asthma controlled by inhaled rescue medication (albuterol, levalbuterol etc) and/or inhaled corticosteroids
- •Ability to give informed consent
- •Ability to perform pulmonary function tests
- •Ability to tolerate the initial Ventavis inhalation
- •Ability to comply with the study protocol
排除标准
- •Cigarette smoking
- •Concomitant serious disease such as diabetes, hypertension, coronary heart disease, other lung disease, cancer (other than skin cancer)
- •Pregnancy or lack of contraception (hormonal or barrier)
- •Allergies or intolerance to inhaled iloprost
- •Participation in other ongoing research studies
- •Any psychological problem that the investigators believe might interfere with the conduct of the investigation.
- •Cigarette smoking
- •History of bleeding disorder, use of anticoagulants
- •Viral upper respiratory tract infection within the last 6 weeks
- •Table of upper limit for steroid use Beclomethasone dipropionate HFA-MDI 480 Budesonide DPI 1200 Flunisolide HFA-MDI 640 Fluticasone HFA-MDI 440 Fluticasone DPI 500 Mometasone DPI 440 Triamcinolone 1500 (Table adapted from EPR3, daily doses are in micrograms) Asthmatics requiring higher doses of inhaled corticosteroids than those given above, or using oral steroids, leukotriene modifiers, mast cell stabilizers, omalizumab, theophylline or long acting beta agonists will be excluded.
- •.Any screening laboratory blood test value outside the normal range will exclude the individual from the study, though an isolated abnormal value could be retested at an interval of no less than a week.
结局指标
主要结局
PD20FEV1 methacholine
时间窗: two weeks
Provocative dose of methacholine resulting in a 20% fall in FEV1 from baseline
次要结局
- asthma related symptoms(4 weeks)
- asthma control(4wks)
- FEV1(2wks)
- Exhaled nitric oxide(2 wks)
- Interleukin 17(2wks)
研究者
研究点 (2)
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