NCT01023516已完成2 期
A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally Twice Daily to Subjects With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Budesonide/Formoterol
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
- 615
- 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 efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the 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
- Treatment
- 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
- •FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator
- •Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
- •At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit
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
- •Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
研究组 & 干预措施
1
Experimental
干预措施: AZD9668 (Drug)
2
Placebo Comparator
干预措施: 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 (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
End-value Pre-bronchodilator FEV1 (L)
时间窗: up to week 12
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
次要结局
- Incremental Shuttle Walk Test - End Value(Week 12 - visit 6)
- Post-bronchodilator FEV1 (L) - Baseline(Day 1)
- Post-bronchodilator FEV1 (L) - End-value(up to week 12)
- Pre-bronchodilator FVC (L) - Baseline(Day 1)
- Pre-bronchodilator FVC (L) - End-value(up to week 12)
- Endurance Shuttle Walk Test - Baseline(Day 1)
- Post-bronchodilator FVC (L) - Baseline(Day 1)
- Post-bronchodilator FVC (L) - End-value(up to week 12)
- Baseline Pre-bronchodilator FEV6 (L)(Day 1)
- End-value Pre-bronchodilator FEV6 (L)(up to week 12)
- Baseline Post-bronchodilator FEV6 (L)(Day 1)
- End-value Post-bronchodilator FEV6 (L)(up to week 12)
- Baseline Pre-bronchodilator FEF25-75% (L/Sec)(Day 1)
- End-value Pre-bronchodilator FEF25-75% (L/Sec)(up to week 12)
- Baseline Post-bronchodilator FEF25-75% (L/Sec)(Day 1)
- End-value Post-bronchodilator FEF25-75% (L/Sec)(up to week 12)
- Pre-bronchodilator IC (L) - Baseline(Day 1)
- Pre-bronchodilator IC (L) - End-value(up to week 12)
- Post-bronchodilator IC (L) - Baseline(Day 1)
- Post-bronchodilator IC (L) - End-value(up to week 12)
- 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(Last 6 weeks on treatment)
- BCSS - Baseline Total Score(Baseline)
- BCSS - End-value Total Score(Last 6 weeks on treatment)
- Sputum Colour - Baseline(Baseline)
- Sputum Colour - End Value(End of treatment week 12)
- Use of Reliever Medication(Last 6 weeks on treatment)
- Incremental Shuttle Walk Test - Baseline(Day 1)
- Endurance Shuttle Walk Test - End Value(Week 12 - visit 6)
- 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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