NCT00263874终止2 期
A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of UK-500,001 Dry Powder For Inhalation (DPI) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 324
- 试验地点
- 29
- 主要终点
- Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
研究概览
简要总结
This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease.
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
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
- •Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition)
- •Smoking history of at least 10 pack-years
排除标准
- •Any significant co-morbid disease
- •Use of any maintenance therapy except short acting bronchodilators
结局指标
主要结局
Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
次要结局
- Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
研究者
研究点 (29)
Loading locations...
相似试验
Unknown
2 期
Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT03790982Zhejiang Hisun Pharmaceutical Co. Ltd.240
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Prothione™ Capsules for Mild to Moderate Coronavirus Disease 2019 (COVID-19)Coronavirus Disease 2019 (COVID-19)NCT04742725Prothione, LLC231
终止
2 期
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT01838499AstraZeneca224
已完成
2 期
The Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection FractionCardiac FailureNCT02932566Manchester University NHS Foundation Trust129
已完成
2 期
Study to Evaluate the Efficacy, Safety and Tolerability of 3% LTX-109 for Nasal Decolonisation of Staphylococcus AureusNasal Decolonization of Staphylococcus AureusNCT05889351Pharma Holdings AS27