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)
ovartis Healthcare Private Limited0 个研究点目标入组 360 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
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
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
研究者
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