NCT00830427撤回2 期
A Phase Iib Randomised Double Blind, Placebo Controlled Parallel Group Study To Investigate The Efficacy And Safety Of Pf-00610355 Over 4 Weeks In Moderate Asthmatic Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Change from baseline trough (24 hours post-dose) FEV1.
研究概览
简要总结
This study (A7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a physician documented history or diagnosis of persistent asthma for at least 6 months prior to Screening Visit
- •Trough FEV1 must be 50-100% of predicted at Screening Visit
- •Subjects who have been maintained on a stable dose of ICS over the previous month prior to screening.
排除标准
- •Subjects who have had a severe asthma exacerbation in the 2 months prior to screening.
- •Subjects meeting any of the criteria of 'very poorly controlled' according to the NIH EPR 3 guidelines.
- •Subjects with evidence or history of cardiovascular disease including angina, myocardial, infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, atrial flutter,supraventricular tachycardia, ventricular tachycardia), systemic hypertension (SBP > 160 mmHg or DBP >100mmHg), pulmonary hypertension or cerebrovascular disease (including transient ischaemic attacks).
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)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline trough (24 hours post-dose) FEV1.
时间窗: 4 weeks
次要结局
- Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score.(week 2, week 4)
- Maximum change from baseline in FEV1 from 0 to 6 hours post-dose.(week 0,week 4)
- Pharmacokinetics of PF-00610355.(week 0, week 4)
- Change from baseline in heart rate.(week 0, week 4)
- Change from baseline in trough FEV1.(week 4)
研究者
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