A Phase III, 26-week 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
- 563
- 试验地点
- 2
- 主要终点
- Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
研究概览
简要总结
This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.
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
- •Adults aged ≥ 40 years
- •Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
- •Smoking history of at least 10 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 received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
- •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 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 300 μg
Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 (Drug)
Indacaterol 150 μg
Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 (Drug)
Placebo to indacaterol
Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 to indacaterol (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
时间窗: 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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.
次要结局
未报告次要终点