NCT00380354已完成2 期
A Two-centre, Randomised, Double-blind, Placebo-controlled, 2-period Cross-over Study to Evaluate the Effect of Treatment With Repeat Doses of Inhaled GSK256066 on the Allergen-induced Late Asthmatic Response in Subjects With Mild Asthma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Asthmatic response
研究概览
简要总结
This study will evaluate the efficacy and safety of GSK256066 in the treatment of subjects with mild bronchial asthma, using a number of clinical and biological markers of efficacy.
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
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
- •Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
- •Pre-bronchodilator FEV1 >75% of predicted at screening.
- •Non-smoker
- •Demonstration of a positive reaction to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair on skin prick testing at screening, or within 12 months of study start.
- •Have Asthmatic response
- •Able and willing to give written informed consent to take part in the study.
- •Available to complete all study measurements.
排除标准
- •History of cardiovascular disease
- •Clinically significant abnormalities in safety laboratory analysis at screening including any subject who has greater than "trace urine protein levels" following urinalysis at screening.
- •History of hayfever
- •The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
- •The subject has tested positive for HIV antibodies.
- •The subject has positive drugs of abuse test.
- •Subjects weighing less than 50kg are to be excluded from participating in the study.
- •The subject has participated in a study with a new molecular entity during the previous 3 months.
- •History of being unable to tolerate or complete methacholine, and/or allergen challenge tests.
- •There is a risk of non-compliance with study medication or study procedures.
- •History of blood donation (450 mL) within 2 months of starting the clinical study.
- •The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.
结局指标
主要结局
Asthmatic response
时间窗: after 7 days of treatment
次要结局
- FEV1 Concentration of exhaled nitric oxide(on day 8 of each treatment period)
- Incidence of treatment emergent adverse events(throughout study)
研究者
研究点 (2)
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