A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma

Astellas Pharma Inc21 个研究点分布在 1 个国家开始时间: 2005年6月最近更新: 2012年6月7日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Astellas Pharma Inc
试验地点: 21
主要终点: The primary outcome is the change in FEV1 from baseline to end-treatment.

研究概览研究设计入排标准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

The purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.

详细描述

The purpose of this randomized, double-blind, placebo-controlled, parallel-group, multi-center designed trial is to determine the safety and efficacy of tacrolimus inhalation aerosol in subjects with persistent asthma.

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

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

•Diagnosis of persistent asthma for at least 6 months
•Require use of beta-agonists at least four times per week

排除标准

•Diagnosis of chronic obstructive pulmonary disease (COPD)

结局指标

主要结局

The primary outcome is the change in FEV1 from baseline to end-treatment.

次要结局

未报告次要终点

研究者

发起方

Astellas Pharma Inc

申办方类型

Industry

研究点 (21)

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