Dose Finding Study in Patients With Mild to Moderate Persistent Asthma: A Parallel Group, Randomised, Placebo Controlled, Double Blind Assessment of Oral Oc000459 Dosed At Three Dose Schedules for Twelve Weeks Finding Study In Patients With Mild To Moderate Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oxagen Ltd
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in one second (FEV1)
研究概览
简要总结
This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
- •Aged 18 to 55 years inclusive.
- •Non smokers for at least the past 12 months with a pack history of less than 10 pack years.
- •Mild to moderate persistent asthma according to GINA4 guidelines for at least 12 months
- •Exclusion criteria:
- •Receipt of prescribed or over the counter medication within 14 days prior to the first study day
排除标准
- 未提供
研究组 & 干预措施
3
干预措施: OC000459 or placebo (Drug)
4
干预措施: OC000459 or placebo (Drug)
2
干预措施: OC000459 or placebo (Drug)
1
干预措施: OC000459 or placebo (Drug)
结局指标
主要结局
Forced expiratory volume in one second (FEV1)
时间窗: 17 weeks
次要结局
- Asthma quality of life questionnaire (AQLQ)(17 weeks)