NCT00396604已完成2 期
A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler vs. Placebo in Patients With Moderate to Severe COPD.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)
研究概览
简要总结
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week.
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
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath.
- •Smoking history of at least 10 pack years
- •FEV1 less than 65% of the predicted normal value and at least 0.75 L
- •Pre-bronchodilator FEV1/FVC less than 70%
排除标准
- •A history of asthma or COPD diagnosis before the age of 40
- •Hospitalization for COPD exacerbation within the previous 6 weeks
- •Respiratory tract infection within 6 weeks
- •Use of long-term oxygen therapy
- •Diabetes type I or uncontrolled diabetes type II
- •Clinically relevant laboratory abnormality or clinically significant condition
- •Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)
次要结局
- FEV1 at time points 30 min, 1, 2 and 4hours post-dose
- Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose
- Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 hours, 23 hours 10 min and 23 hours 45 min post dose
- Standardized FEV1 area under the curve (AUC) between baseline and 4 hours
研究者
研究点 (1)
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