NCT00929708已完成2 期
A 4-week, Phase-II, Double-blind, Placebo-controlled, Randomised, Parallel-group, Multi-centre Study to Assess the Efficacy and Tolerability/Safety of Inhaled AZD3199 Once Daily Compared to 9 μg Formoterol Bid and Placebo in Patients With Moderate to Severe COPD
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
- 329
- 试验地点
- 1
- 主要终点
- FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in 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
- •Current or exsmokers, 10 pack years
排除标准
- •Any clinically relevant abnormal findings at screening examinations
- •Recent COPD exacerbation
研究组 & 干预措施
1
Experimental
AZD3199 low dose
干预措施: AZD3199 (Drug)
2
Experimental
AZD3199 intermediate dose
干预措施: AZD3199 (Drug)
3
Experimental
AZD3199 high dose
干预措施: AZD3199 (Drug)
4
Active Comparator
Formoterol 2x4.5 microgram bid
干预措施: formoterol (Drug)
5
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)
时间窗: 0,5 min, 15 min, 60 min, 2 h, 4 h
change from baseline
FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)
时间窗: 24h, 26h
change from baseline
次要结局
- FEV1 Post Salbutamol Inhalation(Baseline (visit 2) and 26 h after the last morning dose (visit 5).)
- Cmax; the Highest Plasma Concentration of AZD3199 Measured(0,15 min, 1, 4 and 24 hours post dose)
- Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)(Daily, during run-in and treatment)
- AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose(0,15 min, 1, 4 and 24 hours post dose)
- Overall Mean CCQ (Clinical COPD Questionnaire)(Mean over week 0, mean over week 1, mean over week 2, and mean over week 4)
- Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)(At baseline (visit 2) and after 4 weeks of treatment (visit 5).)
- Total Number of Reliever Medication Inhalations Per 24h(During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.)
研究者
研究点 (1)
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