EUCTR2011-006050-91-AT进行中（未招募）不适用
A study to compare the efficacy and safety of once daily QVA149 vs. the once daily concurrent administration of QAB149 plus NVA237 in patients with moderate to severe chronic obstructive pulmonary disease - BEACO
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 184
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 COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010)
- •Post-bronchodilator FEV1 < 80% and = 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
- •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 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 92
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 inclusion criteria may apply
研究者
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