A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 523
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.
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
- •Smoking history of at least 10 pack years
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
- •Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%
排除标准
- •Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
- •Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
- •Patients who have had a respiratory tract infection within 4 weeks prior to Visit
- •Patients with concomitant pulmonary disease
- •Patients with a history of asthma
- •Any patient with lung cancer or a history of lung cancer (within last 5 years)
- •Patients with a history of certain cardiovascular co-morbid conditions
研究组 & 干预措施
QVA149
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
干预措施: indacaterol and glycopyrronium (QVA149) (Drug)
QVA149
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
干预措施: Placebo to fluticasone/salmeterol (Drug)
fluticasone/salmeterol
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
干预措施: fluticasone/salmeterol (Drug)
fluticasone/salmeterol
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
干预措施: Placebo to indacaterol and glycopyrronium (QVA149) (Drug)
结局指标
主要结局
Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12
时间窗: Week 26
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.
次要结局
- Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours(Week 12)
- Forced Vital Capacity at All-time Points (Week 12)(-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12)
- Forced Vital Capacity at All-time Points (Week 26)(-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26)
- Focal Score of the Transitional Dyspnea Index (TDI)(12 weeks and 26 weeks)
- Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)(12 weeks and 26 weeks)
- Mean Change From Baseline in Daily Number of Puffs of Rescue Medication(Baseline, 12 weeks and 26 weeks)
- Change From Baseline in Symptom Scores Reported Using the Ediary(12 weeks and 26 weeks)
- Inspiratory Capacity (IC) at All-time Points (12 Weeks)(12 weeks)
- Inspiratory Capacity (IC) at All-time Points (26 Weeks)(26 weeks)
- Number of Participants With Adverse Events(26 weeks)