A Randomised Open Label, Six Way, Cross-over Scintigraphic Evaluation of the Effect of Inspiratory Flow Rate on Lung and Oropharyngeal Deposition With the Respimat Inhaler vs. a Metered Dose Inhaler (HFA-MDI) Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Whole lung deposition
研究概览
简要总结
The objective of this trial is to compare the total and regional deposition of aerosol in the lungs and oropharynx of patients with COPD at 3 different inspiratory flow rates following inhalation of Berodual delivered via the Respimat inhaler and Berodual? delivered via an HFA-metered dose inhaler.
详细描述
This is a single dose, randomised, active-controlled, six period, open-label cross-over trial in adult patients with COPD.
Berodual (fenoterol hydrobromide 50 g + ipratropium bromide 20 g) will be delivered via the Respimat inhaler and the MDI at 3 different inspiratory flow rates: 15 L/min, 30 L/min and 90 L/min. The optimal flow rate is expected to be 30 L/min for both inhalers.
On each test day patients will practise the inhalation manoeuvre with either a placebo Respimat or MDI inhaler. When patients can perform the inhalation technique correctly and they can obtain the required inspiratory flow rates the placebo will be replaced with the radio-labelled formulation.
The primary analysis will be carried out using the Sign Test. This is a non-parametric analysis in which no assumptions are made about the shape of the distribution of the responses from the Respimat inhaler and from the MDI under the null hypothesis.
Study Hypothesis:
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
- None
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
- •COPD patients:
- •FEV1 less or equal 65 % pre
- •FEV1 less or equal 70 % of FVC
排除标准
- •Patients with any upper respiratory infection in the past 14 days prior to the Screening Visit (Visit 1)
- •Patients with any unstable or life-threatening cardiac arrhythmia
结局指标
主要结局
Whole lung deposition
时间窗: 12 weeks
次要结局
- Device deposition and exhaled air filter deposition(12 weeks)
- FEV1 15, 30 and 60 minutes post-administration (safety only)(12 weeks)
- Peripheral lung zone deposition(12 weeks)
- Ratio of peripheral to central zone deposition(12 weeks)
- Central lung zone deposition(12 weeks)
- Oropharyngeal deposition(12 weeks)
- Intermediate lung zone deposition(10 weeks)