NCT01080924已完成不适用
Demonstration of Broncholytic Effects in Subjects With Obstructive Airway Diseases by Low Frequency Ultrasound
Fraunhofer-Institute of Toxicology and Experimental Medicine2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- • change of the difference of expiratory and inspiratory TOF Expectation: The difference of ex and inspiratory TOF should increase after broncholysis. A change above 10us will be considered significant
研究概览
简要总结
This study is aiming at evaluating whether low frequency ultrasound spectroscopy is a sensitive tool to detect broncholytic effects in patients with obstructive airway diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- 是
入选标准
- •• 18 - 70 years
- •for the healthy cohort:
- •FEV1 > 80 % pred, FEV1/FVC ≥ 70 % pred., no history of allergies or asthma
- •nonsmokers, with a history of less than 1 packyear having been nonsmokers for at least the last five years
- •for the COPD cohort: COPD GOLD I to IV according to current guidelines (2)
- •for the asthma cohort: history of asthma GINA I to IV according to current guidelines (3)
- •BMI ≤ 30 kg/m2
- •Able and willing to give written informed consent
- •Available to complete all study measurements
排除标准
- •• medical conditions which prohibit the use of salbutamol
- •recent exacerbation of COPD or asthma or lower respiratory tract infection (four weeks previous to informed consent visit)
- •past or present disease, which as judged by the investigator, may affect the outcome of the study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, psychiatric disease, endocrine disease or pulmonary disease (including but not confined to asthma, tuberculosis, bronchiectasis or cystic fibrosis)
- •history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
- •risk of non-compliance with study procedures
- •suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
结局指标
主要结局
• change of the difference of expiratory and inspiratory TOF Expectation: The difference of ex and inspiratory TOF should increase after broncholysis. A change above 10us will be considered significant
时间窗: 10 minutes post broncholysis
次要结局
未报告次要终点
研究者
研究点 (2)
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