A 12-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Parallel-group Study to Assess the Efficacy of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 μg b.i.d.) as an Active Control
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- 24-h post-dose trough forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
The study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).
Patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. Patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.
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 COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:
- •Post-bronchodilator FEV1 <80% and ≥40% of the predicted normal value
- •Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
- •Smoking history of at least 10 pack-years
排除标准
- •Patients who have had a COPD exacerbation in the 6 weeks prior to screening
- •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
- •Patients with a history of certain cardiovascular comorbid conditions
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Indacaterol
Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)
干预措施: Indacaterol (Drug)
Formoterol
Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)
干预措施: Formoterol (Drug)
结局指标
主要结局
24-h post-dose trough forced expiratory volume in 1 second (FEV1)
时间窗: After 84 days of treatment
次要结局
- 24-h post-dose trough inspiratory capacity (IC)(After 84 days of treatment)