NCT00949975已完成2 期
A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multinational, Phase IIb Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at 3 Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 838
- 试验地点
- 1
- 主要终点
- Baseline Pre-bronchodilator FEV1 (L)
研究概览
简要总结
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD with symptoms over 1 year
- •Smokers or ex-smokers
- •Males or post-menopausal females between 40 and 80 years old
- •Able to use electronic devices
排除标准
- •Past history or current evidence of clinically significant heart disease
- •Current diagnosis of asthma
- •Patients who require long term oxygen therapy
- •Treatment with antibiotics within 4 weeks of study visit 1b
研究组 & 干预措施
1
Active Comparator
AZD9668 active treatment
干预措施: AZD9668 (Drug)
2
Active Comparator
AZD9668 active treatment
干预措施: AZD9668 (Drug)
3
Active Comparator
AZD9668 active treatment
干预措施: AZD9668 (Drug)
4
Placebo Comparator
AZD9668 placebo treatment
干预措施: AZD9668 Placebo (Drug)
结局指标
主要结局
Baseline Pre-bronchodilator FEV1 (L)
时间窗: Day 1
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
End-value Pre-bronchodilator FEV1 (L)
时间窗: Measured at clinic visits: 1, 4, 8 and 12 weeks
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
次要结局
- Post-bronchodilator FEV1 (L) - Baseline(Day 1)
- Post-bronchodilator FEV1 (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- Pre-bronchodilator FVC (L) - Baseline(Day 1)
- Pre-bronchodilator FVC (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- Post-bronchodilator FVC (L) - Baseline(Day 1)
- Post-bronchodilator FVC (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- Pre-bronchodilator IC (L) - Baseline(Day 1)
- Pre-bronchodilator IC (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- Post-bronchodilator IC (L) - Baseline(Day 1)
- Post-bronchodilator IC (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- PEF - Baseline Measured by Patient at Home (L/Min) in the Morning(Baseline)
- PEF - End-value Measured by Patient at Home (L/Min) in the Morning(Last 6 weeks on treatment)
- FEV1 - Baseline Measured by Patient at Home (L) in the Morning(Baseline)
- FEV1 - End-value Measured by Patient at Home (L) in the Morning(Last 6 weeks on treatment)
- EXACT - Baseline Total Score(Baseline)
- EXACT - End-value Total Score(Measured daily in the evening for 12 weeks)
- BCSS - Baseline Total Score(Baseline)
- BCSS - End-value Total Score(Measured daily in the evening for 12 weeks)
- Sputum Colour - Baseline(Baseline)
- Sputum Colour - End Value(Measured at clinic visits:1, 4, 8 and 12 weeks)
- Use of Reliever Medication(Last 6 weeks on treatment)
- Six-minute Walk Test - Distance Walked at Baseline (m)(Day 1)
- Six-minute Walk Test - End-value Distance Walked (m)(Measured Day 1 and 12 weeks)
- St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline(Day 1)
- St George's Respiratory Questionnaire (COPD) - End-value Overall Score(Measured Day 1 and 12 weeks)
- Exacerbations - Clinic Defined(Duration of the the treatment period - 12 weeks)
研究者
研究点 (1)
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