A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 415
- 试验地点
- 5
- 主要终点
- The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
研究概览
简要总结
This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients
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
- Triple (Participant, 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
- •Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).
- •In addition the following inclusion/exclusion criteria specified below must be met.
- •Patients must complete Stage 2 of the core study B2335S (NCT00463567).
- •Written informed consent to participate in the extension must be obtained.
- •Patients must be able to comply with all study requirements.
排除标准
- •Patients who were randomized to open-label tiotropium in Study B2335S.
- •Patients who participated in Stage 1 of the core study (B2335S).
- •Patients discontinued irrespective of the reason from Stage 2 of the core study.
- •Patients who fail to comply with the core protocol requirements and procedures.
- •Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
- •Patients who in the Investigator's opinion should not participate in the extension study.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Indacaterol 150 µg
Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).
The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
干预措施: Indacaterol (Drug)
Indacaterol 300 µg
Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).
The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
干预措施: Indacaterol (Drug)
Placebo
Placebo once-daily (o.d.) via SDDPI.
The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
干预措施: Placebo (Drug)
结局指标
主要结局
The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
时间窗: Up to 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 With Indacaterol 150 µg or 300 µg Compared to Placebo
时间窗: Up to 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 With Indacaterol 150 µg or 300 µg Compared to Placebo
时间窗: Up to 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 With Indacaterol 150 µg or 300 µg Compared to Placebo
时间窗: Up to 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 pre to post dose 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) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52
时间窗: Weeks 12, 26, 36, 44 and 52
The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.
Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52
时间窗: Weeks 12, 26, 36, 44 and 52
The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 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) at Week 52 of Treatment(Week 52)
- Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52(Weeks 36, 44 and 52)