NCT01483625已完成4 期
A 12-week, Randomised, Placebo-controlled, Double-blind, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Patients With Newly Diagnosed and/or Maintenance Treatment naïve Chronic Obstructive Pulmonary Disease (COPD) Experiencing an Acute Respiratory Infection (TICARI 1: Tiotropium In COPD Patients With an Acute Respiratory Infection 1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 27
- 主要终点
- Trough FEV1 After 12 Weeks on Study Drug
研究概览
简要总结
The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.
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 —（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
tiotropium 18mcg
Experimental
active
干预措施: tiotropium (Drug)
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Trough FEV1 After 12 Weeks on Study Drug
时间窗: 12 weeks
The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
次要结局
- Time to Recovery From Acute Respiratory Symptoms(12 weeks)
- Trough FVC (in Litres) at 12 Weeks(12 weeks)
- Responder Status at Week 4 Clinic Visit(4 weeks)
- Responder Status at Week 12 Clinic Visit(12 weeks)
- Weekly Rescue Medication Use Over the 12 Weeks of Study(12 weeks)
研究者
研究点 (27)
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