NL-OMON38952撤回3 期
A Randomised, Double Blind, Double Dummy, Parallel Group Study Comparing UMEC/VI (A Fixed Combination Of Umeclidinium and Vilanterol) With Tiotropium In COPD Subjects Who Continue To Have Symptoms on Tiotropium (DB2116960) - DB2116960
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •COPD patients >=40 years of age (see protocol page 26 for details).
- •Treatment with tiotropium for at least 3 months prior to screening (see protocol page 26 for details).
- •(Ex) smokers, at least 10 pack years.
- •Pre and post salbutamol FEV1/FVC ratio <70%.
- •Post salbutamol FEV1 >=50% and <=70% of predicted.
- •A score of at least 2 on the Modified Medical Research Council Dyspnea Scale.
- •Safe contraception for women of childbearing potential.
排除标准
- •Pregnancy, lactation.
- •Bronchial asthma.
- •More than 1 COPD exacerbation in the past 12 months. Exacerbation in the last 6 weeks.
- •Significant ECG abnormalities (see protocol page 28 for details).
- •Currently taking an inhaled corticosteroid as part of their maintenance treatment for COPD.
- •Treatment with other specified (mainly COPD) therapies within a specified time frame (see protocol page 28-30 for details).
研究者
相似试验
进行中（未招募）
不适用
Study To compare Umeclidinium/Vilanterol combination with Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Continue To have Symptoms on Tiotropium.Chronic Obstructive Pulmonary Disease (COPD) which may also be called emphysema or chronic bronchitisMedDRA version: 17.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2012-005007-41-EEGlaxoSmithKline Research & Development Limited666
进行中（未招募）
1 期
Study To compare Umeclidinium/Vilanterol combination with Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Continue To have Symptoms on Tiotropium.Chronic Obstructive Pulmonary Disease (COPD) which may also be called emphysema or chronic bronchitisMedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2012-005007-41-NLGlaxoSmithKline Research & Development Limited739
进行中（未招募）
不适用
Study To compare Umeclidinium/Vilanterol combination with Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Continue To have Symptoms on Tiotropium.Chronic Obstructive Pulmonary Disease (COPD) which may also be called emphysema or chronic bronchitisMedDRA version: 16.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2012-005007-41-ESGlaxoSmithKline, S.A.666
进行中（未招募）
1 期
Study To compare Umeclidinium/Vilanterol combination with Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Continue To have Symptoms on Tiotropium.Chronic Obstructive Pulmonary Disease (COPD) which may also be called emphysema or chronic bronchitisMedDRA version: 16.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855EUCTR2012-005007-41-CZGlaxoSmithKline Research & Development Limited739
进行中（未招募）
不适用
Study To compare Umeclidinium/Vilanterol combination with Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Continue To have Symptoms on Tiotropium.Chronic Obstructive Pulmonary Disease (COPD) which may also be called emphysema or chronic bronchitisMedDRA version: 17.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2012-005007-41-SEGlaxoSmithKline Research & Development Limited666