NCT00379028已完成4 期
A Randomized, Double-blind, Two-way Cross-over Study Evaluating Systemic Bioavailability and Airway Clearance of SymbicortTurbuhaler 320/9mcg vs SeretideDiskus 50/500mcg After Single Inhalations in Patients With COPD and Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers
研究概览
简要总结
The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood concentrations of the steroids will be used as surrogate marker.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COPD patients: ≥40 years of age, Diagnosed COPD with symptoms ≥1 year, Pre-bronchodilatory FEV1 ≤55% of PN, Productive cough with expectoration.
- •Healthy volunteers: ≥18 years of age, Healthy, Pre-bronchodilatory FEV1 >80% of PN, Non-smoker
排除标准
- •COPD patients: Current respiratory tract disorder other than COPD, Asthma before 40 years of age, Significant or unstable cardiovascular disorder,
- •Healthy volunteers: Use of any regular medication or therapy, Pregnancy or breast-feeding,
结局指标
主要结局
Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers
次要结局
- Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients
- Correlation between baseline lung function and AUC of steroids after inhalation.
研究者
研究点 (2)
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