A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in COPD Patients With Moderate to Severe Airflow Limitation
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment
研究概览
简要总结
Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 40 years, patients with airflow limitation indicated by post-bronchdilation FEV1 >=30% and <80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mMRC grade 2 or greater
排除标准
- •prolonged QTCF >450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
QVA149
QVA149 study medication kit will contain blister strips and a unique inhaler. Patients will be instructed to inhale their medication twice a day for 12 weeks.
干预措施: QVA149 (Drug)
fluticasone/salmeterol
Fluticasone/salmeterol study medication kit will contain an inhaler in the manufacturer's device. Patients will be instructed to inhale their medication twice a day for 12 weeks.
干预措施: fluticasone/salmeterol (Drug)
结局指标
主要结局
Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment
时间窗: 12 weeks
Area under the curve (AUC) 0-12 hours for Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment. AUC will be calculated using the trapezoidal rule and standardized with respect to length of time from the first 5 minute to the last measurement at 12 hours.
次要结局
- Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment(Day 1 and Week 12)
- Transition Dyspnea Index (TDI) Focal Score(Week 12)
- Quality of Lfe Assessment with St George's Respiratory Questionaire (SGRQ)(Week 12)
- Change from baseline in daily number of puffs of rescue medication(Week 12)
- Daily symptoms reported by patient(Week 12)
- Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose(Day 1 and Week 12)
- COPD assessment (CAT) test(Week 12)
- Safety and tolerability(Over 12 weeks)
- Area under the curve (AUC) 0-4 hours for FEV1(Day 1 and Week 12)