A Randomized, Double-blind, Placebo-controlled, Multi-center, Two-period Crossover Study to Investigate the Bronchodilatory Effect of 50 µg NVA237 Inhaled Once Daily in Patient With Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14
研究概览
简要总结
This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged greater than 40 years with COPD Current or ex-smokers
排除标准
- •Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo then NVA237 50μg
Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device.
干预措施: Placebo (Drug)
Placebo then NVA237 50μg
Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device.
干预措施: NVA237 (Drug)
NVA237 50μg then placebo
NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
干预措施: Placebo (Drug)
NVA237 50μg then placebo
NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
干预措施: NVA237 (Drug)
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14
时间窗: From Day 1 to 0-24 hours after drug administration on Day 14
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
次要结局
- Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14(From day 1 to 0 -12 hours after drug administration on Day 14)
- Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)(Day 14)
- Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14(From Day 1 to 12 hours-24 hours after drug administration on Day 14)