NCT00073177已完成3 期
A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 819
- 试验地点
- 41
- 主要终点
- change in lung function from baseline to final visit.
研究概览
简要总结
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent bronchial asthma
- •No change in asthma treatment within 4 weeks prior to visit 1
- •Non-smoker or ex-smoker (for 12 months or longer)
排除标准
- •Poorly controlled asthma or seasonal asthma
- •History of lower airway infection four weeks prior to visit 1
- •Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease
- •Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1
- •Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection
- •Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
- •Patients with chronic heart failure
- •Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol
- •Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females
- •Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study
结局指标
主要结局
change in lung function from baseline to final visit.
次要结局
- number of asthma exacerbations
- safety.
- pulmonary function variables
- diary variables
- quality of life variables
- time to first exacerbation
研究者
研究点 (41)
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