Determining the Optimal Dry Powder Adenosine Provocation Test to Assess Small Airways Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- The small airway reaction to provocation with adenosine, reflected by the IOS parameter R5-R20
研究概览
简要总结
Asthma is a frequently occurring inflammatory lung disease that affects the whole bronchial tree including the small airways (<2mm). Since the introduction of the solution hydrofluoroalkane (HFA) technology it is possible to generate medication with small particles of approximately 1-2 μm, and therefore to reach the small airways. However, at this moment the investigators have no reliable instruments to identify the asthmatic subjects who particularly benefit from treatment with inhaled small particles. Recently the investigators research group investigated whether provocation with small and large particles AMP is able to identify responders and non-responders to treatment with small and large particles of inhaled corticosteroids. This provocation technique gave promising results but needs further optimization.
The aim of this study is to determine the optimal particle size of dry powder adenosine to assess small airway involvement in asthma. Secondary, to provide insight in the associations between the standard test, executed with nebulized AMP, and the new test, executed with dry powder Adenosine.
详细描述
This is a cross-over study. The study population consists of 10 non-smoking asthma patients in the age of 18-65 years who have a PC20 metacholine value ≤4.9mg/ml.
Participating subjects perform 6 provocation tests in randomized order: one test with nebulized methacholine, one test with nebulized AMP, four times dry powder adenosine provocation test. (small particles with inhaled with a slow flow, small particles inhaled with a fast flow, large particles inhaled with a slow flow, large particles inhaled with a fast flow)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A doctor's diagnosis of asthma
- •Age: 18-65 years
- •PC20 AMP < 320 mg/ml
- •Non-smoker
- •Steroid naive or steroids have been stopped 4 weeks before entry into the baseline period
排除标准
- •Recent exacerbation asthma (<2 months) or upper respiration tract infection (<2 weeks)
- •Severe airway obstruction at baseline, FEV1pred< 50% or < 1.2L
- •Diagnosis of COPD or any other pulmonary disease that could influence the study results as judged by the investigator
- •Pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator).
结局指标
主要结局
The small airway reaction to provocation with adenosine, reflected by the IOS parameter R5-R20
时间窗: Small airway reaction is measured during each provocation test. The Visits will take place in a period of 6 weeks.
The R5-R20 is measured with the IOS. This a method to determine the resistance of the small airways. The R5-R20 is measured during each provocation test after each provocative step.
次要结局
- The total airway reaction to provocation with adenosine, reflected by the decline in FEV1 (PD20/ PC20 values)(Lung function is measured during each provocation test. All visits take place in a period of 6 weeks.)
研究者
E. van der Wiel
E. van der Wiel, MD
University Medical Center Groningen