NCT01113593已完成2 期
A Randomized, Multiple-Dose, Crossover Study Characterizing the Pharmacodynamic Profiles of Formoterol Fumarate Inhalation Solution and Formoterol Dry Powder Inhaler in Subjects With Stable Chronic Obstructive Pulmonary Disease
Dey0 个研究点目标入组 45 人开始时间: 2010年5月最近更新:
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
- 入组人数
- 45
- 主要终点
- Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil
研究概览
简要总结
The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer
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
- 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
- •Able to understand the requirements of the study and provide informed consent
- •A Clinical diagnosis of COPD
- •A current or prior history of at least 10-pack years of cigarette smoking
- •women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and agree to avoid becoming pregnant for the duration of study
排除标准
- •A Clinical Diagnosis of Asthma
- •Other significant disease than COPD
- •Subjects who radiation or chemotherapy within the previous 12 months
- •Subjects who had any lung resection
- •QTcB greater than 0.460 seconds
- •History of illegal drug abuse or alcohol abuse within the past 5 years
研究组 & 干预措施
1
Experimental
干预措施: Formoterol Fumarate (Drug)
2
Experimental
干预措施: Formoterol Fumarate (Drug)
3
Experimental
干预措施: Formoterol Fumarate (Drug)
4
Experimental
干预措施: Foradil Aerolizer (Drug)
5
Experimental
干预措施: Foradil Aerolizer (Drug)
结局指标
主要结局
Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil
时间窗: 12 hours on Day 1 and Day 7 of dosing during each treatment period
次要结局
未报告次要终点
研究者
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