CTRI/2010/091/000665已完成3 期
A 52-week treatment, multi-center, randomized, double-blind, parallel-group,active controlled study to evaluate the effect of QVA149 (110/50 microgram o.d.) vs NVA237 (50 microgram o.d.) and open-label tiotropium (18 microgram o.d.) on COPDexacerbations in patients with severe to very severe chronic obstructive pulmonary disease (COPD)
Novartis Healthcare Pvt Ltd16 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2010年8月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,200
- 试验地点
- 16
- 主要终点
- 1.Superiority of QVA149 over NVA237 in terms of rate of COPD exacerbations
研究概览
简要总结
Target number of patients is 200.Planned FPFV in India is 2nd August 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female adults aged greater than or equal to 40 yrs Severe or very COPD [Stage III or IV as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008] Smoking history of at least 10 pack years Post-bronchodilator FEV1 less than 50 percent of the predicted normal value and post- bronchodilator FEV1 or FVC less than 70percent Documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and or antibiotics.
排除标准
- •Patients requiring long term oxygen therapy (greater than 15 h a day) on a daily basis for chronic hypoxemia Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 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 Other protocol-defined inclusion or exclusion criteria may apply.
结局指标
主要结局
1.Superiority of QVA149 over NVA237 in terms of rate of COPD exacerbations
时间窗: 52 weeks
次要结局
- Superiority of QVA149 over NVA237 in terms of time to first COPD exacerbation(52 weeks)
- Safety and tolerability of QVA149 versus NVA237 assessed by adverse events, electrocardiogram (ECG), laboratory tests, and vital signs(52 weeks)
研究者
研究点 (16)
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