NCT01104012已完成不适用
The VAPARA Study: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
Centre Hospitalier Universitaire de Nīmes3 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2010年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 3
- 主要终点
- Proteomic profile of each patient
研究概览
简要总结
The purpose of this study is to verify and validate the intrinsic diagnostic value in terms of sensitivity and specificity of proteomic profiles determined during a pre-study for discriminating between allergy related asthma and allergy related rhinitis.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed consent
- •never-smokers or non-smoking for at least 2 years + < 5 packs per year
- •capable of understanding the study
- •patient is affiliated with a social security system
- •positive skin tests (at least one for Montpellier region pneumoallergens)
- •treated with nasal or inhaled corticoids, leucotriene receptor antagonists, anti-IgE, Theophylline, anti-histamines, sodium cromoglycate, beta-blockers, benzodiazépine, oral corticoids: all these treatments must be interrupted for at least 72 hours
排除标准
- •Co-morbidities: none; no co-morbidities are accepted
- •dental infections (any) during the 3 months preceding the study
- •suspected alcoholism or drug abuse
- •chronic viral infection (hepatitis, HIV)
- •patient under guardianship
结局指标
主要结局
Proteomic profile of each patient
时间窗: One day (snapshot)
The attribution of a proteomic profile as either "asthmatic" or "rhinitis". Proteomic profiles are determined accordig to the SELDI-TOF method. This is a transversal study validating proteomic profiles as a new diagnostic test.
次要结局
未报告次要终点
研究者
研究点 (3)
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