NCT01682863已完成3 期
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- Number of Patients With Adverse Events, Serious Adverse Events, and Death
研究概览
简要总结
This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 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
- 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
- •Patients with stable COPD according to GOLD strategy (GOLD 2011).
- •Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.
- •Current or ex-smokers who have a smoking history of at least 10 pack years.
- •Patients with an mMRC ≥ grade 2
排除标准
- •History of long QT syndrome or prolonged QTc
- •Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit
- •Patients with Type I or uncontrolled Type II diabetes
- •Patients with a history of asthma or have concomitant pulmonary disease
- •Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
- •Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
QAB149
Active Comparator
QAB149 75 μg capsules
干预措施: Placebo (Drug)
QVA149 dose 1
Experimental
QVA149 27.5/12.5 μg capsules
干预措施: QVA149 (Drug)
QVA149 dose 2
Experimental
QVA149 27.5/25 μg capsules
干预措施: QVA149 (Drug)
QAB149
Active Comparator
QAB149 75 μg capsules
干预措施: QAB149 (Drug)
结局指标
主要结局
Number of Patients With Adverse Events, Serious Adverse Events, and Death
时间窗: 56 weeks
The overall rate of adverse events reported from initiation through 30 days post last dose.
次要结局
- Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation(52 weeks)
- Time to Premature Discontinuation of Treatment(56 weeks)
- Change From Baseline in Pre-dose Trough FEV1(Day 29, 57,, 85, 141, 197, 253, 309 and 365)
- Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period(52 weeks)
- Change From Baseline in 1 Hour Post-dose FEV1 Measurements(Day 1, 29, 57, 85, 141, 197, 253, 309, and 365)
- Change From Baseline in FVC Measurement at All Post-baseline Time Points(Day1, 29, 57, 85, 141, 197, 253, 309, and 365)
- Change From Baseline in Mean Total Daily Symptom Scores(52 weeks)
研究者
研究点 (1)
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