NCT00783406已完成2 期
A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.
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
- 20
- 试验地点
- 1
- 主要终点
- To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
研究概览
简要总结
This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 of <0.
- •Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
- •Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
- •Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.
排除标准
- •Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
- •History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
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)
结局指标
主要结局
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
时间窗: up to 8 days post dose
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
时间窗: up to 24 hours post dose
次要结局
- To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.(up to 24 hours post dose)
- To investigate the exposure/response relationship of PF-00610355.(up to 8 days post dose)
研究者
研究点 (1)
Loading locations...
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