A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol 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
- 318
- 试验地点
- 3
- 主要终点
- Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
研究概览
简要总结
This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.
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, 2008) and:
- •Smoking history of at least 10 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 had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for 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 75 µg
Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Indacaterol (Drug)
Placebo
Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Placebo to indacaterol (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
时间窗: after 12 weeks
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.
次要结局
- Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment(after 12 weeks)