A Multi-center, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study to Assess the Effect of 50µg Inhaled NVA237 on Exercise Endurance in Patients With Moderate to Severe COPD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment
研究概览
简要总结
The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.
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
- •Patients who signed an Informed Consent Form prior to initiation of any study-related procedure
- •Patients with moderate to severe stable COPD (clinical diagnosis in compliance with GOLD 2008)
- •Current or ex-smokers with a smoking history ≥ 10 pack years. (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.).
- •Patients with a post-bronchodilator FEV1 ≥ 40 and < 70% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 during screening. (Post referred to the highest post-bronchodilator value after inhalation of 80 μg ipratropium bromide)
- •Increase in FEV1 from pre- to post-bronchodilator assessment of ≥ 5%
排除标准
- •Pregnant women or nursing mothers
- •Women of child-bearing potential
- •Patients who had a COPD exacerbation (whether hospitalized or not) in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4
- •Patients who had a lower respiratory tract infection in the 6 weeks prior to Visit 1
- •Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia
- •Patients with resting (5 min) oxygen SaO2 (or SpO2) saturation on room air of < 85%
- •Patients with a maximum workload (Wmax) value < 20 W (as determined by the incremental cycle endurance test) at Visit
- •Patients whose exercise endurance time at sub-maximal workload was above 25 min at baseline
- •Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would have been at potential risk if enrolled into the study
- •Patients with a history of long QT syndrome or whose QTc was prolonged (> 450 ms for males and > 470 ms females) at screening (Fredericia's correction)
- •Other protocol-defined inclusion/exclusion criteria applied
研究组 & 干预措施
NVA237 followed by Placebo
Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days
Period 2: Matching placebo via NEOHALER inhaler device for 21 days
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study.
干预措施: NVA237 (Drug)
NVA237 followed by Placebo
Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days
Period 2: Matching placebo via NEOHALER inhaler device for 21 days
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study.
干预措施: Placebo (Drug)
Placebo followed by NVA237
Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days
Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study.
干预措施: NVA237 (Drug)
Placebo followed by NVA237
Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days
Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days
The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
Salbutamol (albuterol) was used as rescue medication throughout the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment
时间窗: Day 21
SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.
次要结局
- Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment(Day 21)
- Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment(Day 21)
- Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)(Day 21)
- Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)(Day 21)
- Specific Airways Conductance (SGaw)(Day 21)
- Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment(Day 21)
- Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment(Day 21)
- Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1(Day 1)