A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 1
- 主要终点
- Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment
研究概览
简要总结
To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic 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
- None
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
- •Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 50% of the predicted normal value and post-bronchodilator FEV1/FVC < 0.7 (COPD Grade 1 or 2 by severity of airflow limitation (GOLD 2015)
- •Patients with CAT score ≥ 10 at Visit 0 and Visit
- •Patients who are on and have been on tiotropium monotherapy for the past 3 months.
- •0 or 1 COPD exacerbation in the previous 12 months (not leading to hospital admission).
排除标准
- •Treatment with any inhaled corticosteroid (ICS) in the 3 months prior to Visit
- •COPD exacerbation between Visit 0 and
- •Patients with concomitant pulmonary disease
- •Patients with a history of respiratory infection within 4 weeks prior to Visit
- •Prior or current diagnosis of asthma.
- •Presence of any contraindication, warning, precaution, hypersensitivity to LABA and LAMA
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Indacaterol and glycopyrronium (QVA149)
QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks
干预措施: Indacaterol and glycopyrronium (QVA149) (Drug)
Tiotropium
Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks
干预措施: Tiotropium (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment
时间窗: Week 12
Spirometry was performed according to internationally accepted standards. Trough FEV1 is defined as the mean of 45 minute and 15 minute pre-dose values.
次要结局
- Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment(mean of 45 min and 15 min pre-dose week 4)
- Baseline Transitional Dyspnea Index (TDI) Focal Score(Week 12)
- Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT)(Week 12)
- Daily Rescue Medication Use (Number of Puffs)(Week 12)