临床试验/NCT02366637

NCT02366637终止2 期

A Randomized, Double-blind, Placebo-controlled 2-way Crossover Study To Evaluate The Efficacy, Safety And Tolerability Of Pf-03715455 Administered Twice Daily By Inhalation For 4 Weeks In Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease (Copd)

Pfizer5 个研究点分布在 1 个国家目标入组 13 人开始时间: 2015年1月最近更新: 2016年7月6日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Pfizer
入组人数: 13
试验地点: 5
主要终点: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.

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: Triple (Participant, Care Provider, 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

•Female subjects of non-childbearing potential and male subjects between the ages of 40 and 80 years, inclusive
•Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD and who meet the criteria for Stage II-III disease
•Subjects must have a smoking history of at least 10 pack-years

排除标准

•Current evidence or history within the previous 6 months of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data
•A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of Screening

研究组 & 干预措施

Placebo

Placebo Comparator

Double blind placebo for PF-03715455

干预措施: Placebo (Drug)

PF-03715455

Experimental

干预措施: PF-03715455 (Drug)

结局指标

主要结局

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4

时间窗: Baseline (Day 1), Day 29 (Week 4)

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.

次要结局

Change From Baseline in Sputum Cell Counts Over 4 Weeks(Baseline, Week 1 to Week 4)
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4(Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4))
Trough Plasma Concentration (Ctrough) of PF-03715455(Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29)
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks(Baseline, Week 1 to Week 4)
Maximum Observed Plasma Concentrations (Cmax) of PF-03715455(Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29)

研究者

发起方

Pfizer

申办方类型

Industry

责任方

Sponsor

研究点 (5)

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