NCT00242307已完成2 期
A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- change in lung function parameters.
研究概览
简要总结
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main inclusion criteria:
- •Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)
- •No change in asthma treatment during the last 4 weeks prior to the registration
- •Non-smokers or ex-smokers for 12 months or more
- •%FEV1 ranging between 60 and 80%
排除标准
- •Patients with poorly controlled asthma
- •Inhalation therapy exceeding low dose during 4 weeks prior to the registration
- •Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation
结局指标
主要结局
change in lung function parameters.
次要结局
- pulmonary function test (spirometry), asthma symptoms, rescue medication, evaluation of QOL, asthma exacerbation, adverse events, pharmacokinetics.
研究者
研究点 (1)
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