CTRI/2010/091/000285已完成2 期
A randomized, double-blind, placebo-controlled, 2-period,cross-over study to assess the efficacy and safety ofdiffering doses of NVA237 administered either once dailyor twice daily, in patients with moderate to severe chronicobstructive pulmonary disease (COPD)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 6
- 主要终点
- To evaluate the relationship of NVA237 on trough forced expiratory volume in one second (FEV1)
研究概览
简要总结
Target number of patients from India is 72.Planned FPFV in India is 30 July 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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female patients age 40 years or more Diagnosis of COPD (moderate-to-severe 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 <80% and ≥30% of the predicted normal value Post-bronchodilator FEV1/FVC (forced vital capacity) <0.7.
排除标准
- •Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to the first visit * Patients who have had a respiratory tract infection within 4 weeks prior to the first visit * Patients with concomitant pulmonary disease or a history of asthma * Patients with diabetes Type I or uncontrolled diabetes Type II * Any patient with lung cancer or a history of lung cancer * Patients with a history of certain cardiovascular comorbid conditions * Patients with eczema, known high IgE levels or a known positive skin prick test * Patients participating in the active phase of a pulmonary rehabilitation programme * Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To evaluate the relationship of NVA237 on trough forced expiratory volume in one second (FEV1)
时间窗: Time Frame: 28 days
次要结局
- To evaluate the relationship of NVA237 on FEV1 AUC0-24 hours(Time Frame: 28 days)
- To evaluate the safety and tolerability of NVA237 over the course of treatment(Time Frame: 28 days)
研究者
研究点 (6)
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