NCT00671073已完成2 期
Phase II Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients With COPD
Forest Laboratories3 个研究点 分布在 1 个国家目标入组 427 人开始时间: 2008年5月5日最近更新:
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
- 入组人数
- 427
- 试验地点
- 3
- 主要终点
- Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
This study will assess the safety and efficacy of a range of oglemilast doses. The study will be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to one of three doses of oglemilast or placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of COPD as defined by GOLD criteria (2006); post-bronchodilator FEV1/FVC <70%, and post-bronchodilator FEV1 >30% and < 80% predicted
- •Current or former cigarette smoker
排除标准
- •Long-term oxygen use of > 15 hours a day
- •Symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms)
- •Any COPD exacerbations within 30 days prior to study entry or during run-in
- •History of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months
- •Presence of clinical significant pulmonary disease other than COPD
研究组 & 干预措施
1
Active Comparator
Oglemilast low dose, oral administration once daily for 12 weeks
干预措施: Oglemilast (Drug)
2
Active Comparator
Oglemilast middle dose, oral administration, once daily for 12 weeks
干预措施: Oglemilast (Drug)
3
Active Comparator
Oglemilast high dose, oral administration, once daily for 12 weeks.
干预措施: Oglemilast (Drug)
4
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)
时间窗: After 12 weeks of treatment
次要结局
- Pre-bronchodilator forced vital capacity (FVC)(After 12 weeks of treatment)
研究者
研究点 (3)
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