NCT00808288已完成2 期
A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.
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
- Pfizer
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Change from baseline in trough FEV1
研究概览
简要总结
To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (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
- Double (Participant, Investigator)
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
- •Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
- •Diagnosis of moderate COPD for a minimum of 6 months.
- •Stable disease for at least 1 month prior to screening
排除标准
- •More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
- •History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.
研究组 & 干预措施
PF-00610355
Experimental
干预措施: PF-00610355 (Drug)
PF- 00610355
Experimental
干预措施: PF - 00610355 (Drug)
PF - 00610355
Experimental
干预措施: PF- 00610355 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Salmeterol
Active Comparator
干预措施: Salmeterol (Drug)
结局指标
主要结局
Change from baseline in trough FEV1
时间窗: 6 week
次要结局
- Change from baseline in peak FEV1(0-6 hours /6 weeks)
- Maximal and mean changes from baseline in heart rate, QTc and plasma potassium(each visit)
- Change from baseline in trough and peak FEV6, FVC and IC(6 weeks)
- Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)(2 and 4 weeks)
- Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)(2,4,6 weeks)
- Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).(weekly)
研究者
研究点 (1)
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