Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- correlation of the two parameters PC20 FEV1 and PD20 FEV1
研究概览
简要总结
This study is meant to compare two routine diagnostic approaches in patients with bronchial asthma. Patients are challenged with methacholine in order to measure their bronchial response. We compare the evaluation of the effects of incremental concentrations versus incremental dosages.
详细描述
Bronchial methacholine challenge is well established in asthma diagnostic and research purposes. ATS guidelines provide a short five-breath dosimeter protocol using a five-step dilution schedule. The Viasys APS system enables a feasible and less time consuming provocation with incremental dosages. In 48 young adults with bronchial hyperreactivity (BHR) the ATS-protocol with a five-step protocol using a single dilution of 16 mg/ml methacholine should be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Age 12-45 years
- •Known bronchial hyperreactivity
排除标准
- •Age < 12 > 45 years
- •Clinical asthma requiring regular inhalation
- •Vital capacity < 80%
- •FEV1 < 75%
- •Chronic disease conditions or infections
- •Pregnancy
- •Inhalative or systemic steroid use
- •Substance abuse
- •Incapability of understanding the study's purpose and performance
研究组 & 干预措施
A
Methacholine challenge, five-breath dosimeter protocol
干预措施: Bronchial methacholine provocation (Procedure)
B
Methacholine challenge five incremental dosages protocol
干预措施: Bronchial methacholine provocation (Procedure)
结局指标
主要结局
correlation of the two parameters PC20 FEV1 and PD20 FEV1
时间窗: feb 2007 - dec 2007
次要结局
- kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration(see above)
研究者
Johannes Schulze MD
Consultant Pediatric Allergy and Pulmonológy
Johann Wolfgang Goethe University Hospital