CTRI/2009/091/000066已完成3 期
A Phase III, 26-Week Multi-Center Randomized Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Novartis Healthcare Pvt Ltd3 个研究点 分布在 1 个国家目标入组 558 人开始时间: 2009年12月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 558
- 试验地点
- 3
- 主要终点
- Forced expiratory volume in 1 second (FEV1) at approximately 23.5 hours after inhalation of indacaterol [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
研究概览
简要总结
The number of patients proposed to be recruited from India is 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
入选标准
- •Inclusion Criteria:Adults aged ≥ 40 years Diagnosis of 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 FEV1 <80% and ≥30% of the predicted normal value
- •Post-bronchodilator FEV1/FVC < 70%.
排除标准
- •Exclusion Criteria:
- •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 h 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.
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1) at approximately 23.5 hours after inhalation of indacaterol [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
次要结局
- Long term safety, including adverse events [ Time Frame: During 26 weeks of treatment ] [ Designated as safety issue: Yes ]
研究者
研究点 (3)
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