NCT00465959已完成1 期
Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Endo Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
研究概览
简要总结
To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD
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 (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
- •Male or female COPD patients between the ages of 40 and 80 years
- •Smoking history of at least 10 pack years
- •Not currently using (or able to wash out of) any long acting bronchodilators
排除标准
- •Candidate on a waiting list for surgery while on study
- •Using long-term oxygen therapy
- •Hospitalization for COPD exacerbation
研究组 & 干预措施
400 mg TrIP
Experimental
干预措施: trospium chloride inhalation powder (TrIP) (Drug)
800 mg TrIP
Experimental
干预措施: trospium chloride inhalation powder (TrIP) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
次要结局
未报告次要终点
研究者
研究点 (1)
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