EUCTR2012-002057-38-SI进行中（未招募）不适用
A placebo and active controlled study to assess the long-term safety of once daily QVA149 for 52 weeks in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation
ovartis Pharma Service AG0 个研究点目标入组 1,224 人开始时间: 2012年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female adults aged =40 yrs
- •Smoking history of at least 10 pack years
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate to severe airflow limitation as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- •Guidelines, 2011)
- •Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and = 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
- •Modified Medical Research Council questionnaire grade of 2 or higher
- •Other protocol defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 612
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 612
排除标准
- •Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- •Patients with concomitant pulmonary disease
- •Patients with a history of asthma
- •Any patient with lung cancer or a history of lung cancer
- •Patients with a history of certain cardiovascular co-morbid conditions
- •Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
- •Patients in the active phase of a supervised pulmonary rehabilitation program
- •Patients contraindicated for inhaled anticholinergic agents and ß2 agonists
- •Other protocol defined exclusion criteria may apply
研究者
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