A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 4
- 主要终点
- Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
研究概览
简要总结
This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:
- •Smoking history of at least 20 pack-years.
- •Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value.
- •Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%.
排除标准
- •Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization.
- •Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia.
- •Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- •Patients with concomitant pulmonary disease.
- •Patients with 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.
- •Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time.
- •Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged.
- •Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
- •Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
Indacaterol 150 µg
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
干预措施: Indacaterol 150 μg capsules (Drug)
Indacaterol 300 µg
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
干预措施: Indacaterol 300 μg capsules (Drug)
Placebo
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
时间窗: End of treatment (Week 12 + 1 day, Day 85)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
次要结局
- Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2(After Week 2 (Day 15))
- Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4(After Week 4 (Day 29))
- Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8(After Week 8 (Day 57))
- Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)(Prior to last dose at Week 12 (Day 84))