NCT00859404Unknown2 期
A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Dose Range Finding Study to Evaluate the Efficacy of Oglemilast in the Treatment of Stable Mild to Moderate Persistent Asthma
Glenmark Pharmaceuticals Europe Ltd. (R&D)1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1
研究概览
简要总结
The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. The study involves two weeks of run in period. This is a placebo controlled study. One of the four treatment arms is placebo. The duration of treatment is 12 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1. oglemilast
Experimental
干预措施: oglemilast (Drug)
2. oglemilast
Experimental
干预措施: oglemilast (Drug)
3. oglemilast
Experimental
干预措施: oglemilast (Drug)
4. placebo
Placebo Comparator
干预措施: oglemilast (Drug)
结局指标
主要结局
Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1
时间窗: 12 weeks
次要结局
- Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1(Days 8, 36, 64)
- Change from baseline at days 8, 36 and 64 in morning pre-dose vital capacity (FVC), peak expiratory flow (PEF), forced expiratory flow 25-75% (FEF25-75%)(days 8, 36 and 64)
- Change from baseline in morning and evening PEF (based on patient diary)(12 weeks)
- Change in asthma day time symptom score from baseline at day 85(12 weeks)
- Change in asthma night time symptom score from baseline at day 85(12 weeks)
- Change in number of night time awakenings from baseline at day 85(12 weeks)
- Frequency and the use of rescue (reliever) medication (salbutamol)(12 weeks)
- Frequency and severity of asthma exacerbations(12 weeks)
- Investigator global impression of change from baseline to day 85(12 weeks)
- Patient global impression of change from baseline to day 85(12 weeks)
- Pharmacokinetic parameters of oglemilast(12 weeks)
研究者
研究点 (1)
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