NCT00532350已完成1 期
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Efficacious Dose of QAT370 Compared to Open-label Tiotropium Bromide Following Once Daily Dosing for 7 Days in COPD Patients
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
- Novartis
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Forced expiratory volume in 1 second
研究概览
简要总结
This study will assess the safety and tolerability of QAT370 compared to tiotropium 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
- •Patients between 40 and 80 years of age with controlled COPD.
- •Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment.
- •Body mass index (BMI) must be within the range of 18 to 32 kg/m2
排除标准
- •Participation in any interventional clinical investigation with 4 weeks of study start
- •Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
- •Past medical personal or close family history of clinically significant ECG abnormalities
- •Any medical condition that may interfere with exercise testing or that may make spirometry unsafe
- •A known hypersensitivity to the drug.
- •History of immunocompromise, including a positive HIV test result.
- •History of drug or alcohol abuse within 12 months of study start
- •Any condition that may compromise patient safety
研究组 & 干预措施
1
Experimental
QAT370
干预措施: QAT370 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
3
Active Comparator
Tiotropium
干预措施: Tiotropium (Drug)
结局指标
主要结局
Forced expiratory volume in 1 second
时间窗: Days 1 and 7
次要结局
- Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.(Days 1 and 7)
研究者
研究点 (2)
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