CTRI/2009/091/000910已完成3 期
A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Novartis Healthcare Pvt Ltd8 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2010年2月18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
- 800
- 试验地点
- 8
- 主要终点
- Trough Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
Target number of patients from India is 180.Planned FPFV for India is 30th Jan 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 0.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- •Patients with moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD Guidelines 2008).
- •Current or ex-smokers who have a smoking history of at least 10 pack years.
- •(Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- •Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.
排除标准
- •1.Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1 2.Patients with concomitant pulmonary disease 3.Patients with a history of asthma 4.Any patient with lung cancer or a history of lung cancer 5.Patients with a history of certain cardiovascular comorbid conditions 6.Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency 7.Patients in the active phase of a supervised pulmonary rehabilitation program 8.Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Trough Forced Expiratory Volume in 1 Second (FEV1)
时间窗: 12 weeks
次要结局
- * Transition Dyspnea Index (TDI)(26 weeks)
- * George's Respiratory Questionnaire (SGRQ)(26 weeks)
研究者
研究点 (8)
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