A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,439
- 试验地点
- 1
- 主要终点
- Trough Forced Expiratory Volume in 1 Second (FEV1).
研究概览
简要总结
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 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
- •Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
- •Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:
- •Smoking history of at least 10 pack years, both current and ex-smokers are eligible
- •A documented history of at least 1 moderate or severe exacerbation in the previous 12 months
排除标准
- •Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
- •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
Tiotropium
Tiotropium 18 µg o.d. delivered via the handihaler®
干预措施: Tiotropium (Drug)
Indacaterol
Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
干预措施: Indacaterol 150 µg (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in 1 Second (FEV1).
时间窗: 12 weeks
The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.
次要结局
- Rate of COPD Exacerbations(52 weeks)