A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Efficacy of Indacaterol (300 µg o.d.) Using Salmeterol (50 µg b.i.d.) as an Active Control in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment
研究概览
简要总结
This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe 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
- None
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 COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:
- •Smoking history of at least 20 pack-years
- •Post-bronchodilator 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 Visit 1 or during the run-in period
- •Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
- •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
- •Patients with a history of certain cardiovascular comorbid conditions
- •Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Indacaterol 300 µg
Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
干预措施: Indacaterol 300 µg (Drug)
Salmeterol 50 µg
Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
干预措施: Salmeterol 50 µg (Drug)
结局指标
主要结局
The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment
时间窗: 52 weeks
The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate \<40 bpm or \<= to 50 bpm and a decrease from baseline \>= to 15 bpm. High Pulse Rate was defined as a pulse rate \>130 bpm or \>= to 120 bpm and an increase from baseline \>= to 15 bpm.
The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment
时间窗: 52 weeks
The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: \<75 mmHg or \<= to 90 mmHg and a decrease from baseline \>= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: \>200 mmHg or \>= to 180 mmHg and an increase from baseline \>= to 20 mmHg.
The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment
时间窗: 52 weeks
The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \<40 mmHg or \<= to 50 mmHg and a decrease from baseline \>= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \>115 mmHg or \>= to 105 mmHg and an increase from baseline \>= to 15 mmHg.
The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment
时间窗: 52 weeks
The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTc interval \>450 ms for males and \>470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and \>60 ms.
Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52
时间窗: 4, 8, 12, 24, 36, 44, and 52 weeks
The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.
Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52
时间窗: 4, 8, 12, 24, 36, 44, and 52 weeks
The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.
次要结局
- Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks(After 12, 24 and 52 weeks)