Repeatability of a Single Concentration and Single-step Bronchial Allergen Challenge With Grass Pollen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- repeatability of a bolus-dose inhalative allergen challenge with grass pollen
研究概览
简要总结
The study is meant to establish a one-step challenge with grass-pollen in patients sensitized for grass-pollen. Therefore the investigators compare a multi-step challenge with grass-pollen with an one-step challenge in order to survey the repeatability and safety.
详细描述
Background:
Specific provocation with inhaled allergens is an established tool in clinical practice and research, supporting the understanding of pathophysiology of allergic asthma, and analysing the efficacy of new therapies. This study examines the repeatability of a bolus-dose inhalative allergen challenge with grass pollen.
Method:
Forty grass pollen allergics should undergo an incremental-dose grass pollen challenge to calculate their PD20-dose. This calculated dose will be applicated twice to analyse the repeatability of the bolus dose challenge. Before and twenty-four hours after the provocation, exhaled nitric oxid (FeNO) will be determined as a marker of bronchial inflammation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •age >12 <45 years
- •known sensitization for grass-pollen
- •informed consent
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
结局指标
主要结局
repeatability of a bolus-dose inhalative allergen challenge with grass pollen
时间窗: feb 2007 - aug 2008
次要结局
- kappa-index of concordance: reliability of the three procedures titrated skin prick-test, incremental challenge and bolus challenge with grass pollen.(feb 2007 - dec 2007)
研究者
Johannes Schulze MD
Cosultant Pediatric Allergy and Pulmonology
Johann Wolfgang Goethe University Hospital