NCT01056692已完成2 期
A Phase II Study of oc000459 in Subjects With Allergic Asthma; a Randomised, Double Blind, Two Way Balanced Crossover Comparing oc000459 With Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oxagen Ltd
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The primary endpoint is the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 3 and 10 hours after allergen challenge.
研究概览
简要总结
OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic response in the lungs, namely cat hair, pollen or house dust mite and methacholine.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
- •FEV1 >65% of predicted on at least two occasions at screening.
- •At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
- •No steroid usage in the past 12 weeks.
- •Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
- •Non smokers for a minimum of 6 months; less than 10 pack year history.
排除标准
- •Respiratory tract pathology other than allergic asthma.
- •Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
- •Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
研究组 & 干预措施
Active compound
Active Comparator
OC000459 orally
干预措施: OC000459 (Drug)
Placebo
Placebo Comparator
Placebo given orally
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint is the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 3 and 10 hours after allergen challenge.
时间窗: Primary outcome is measured after 15 days of treatment with active or placebo
次要结局
- Secondary biological activity endpoints include the diminution of the early asthmatic response to bronchial allergen challenge sputum eosinophilia, the methacholine PC20 after allergen challenge and exhaled NO pre- and post-allergen.(These measures are examined after 15 days of treatment with either active or placebo)
研究者
研究点 (2)
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