Validation Study of the ALYATEC Allergen Exposure Chamber (EEC) by Determining the Concentration of Cat Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Cat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Alyatec
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Determine the concentration of cat allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to cat.
研究概览
简要总结
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the Alyatec environmental exposure chamber (EEC).
The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in Alyatec EEC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects having signed the informed consent
- •Subjects affiliated to a social security scheme
- •Non-specific bronchial hyperreactivity (HRBNS) assessed by a positive methacholine test
- •FEV1 value > 70% of theoretical FEV1 value
- •Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
- •Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception.
- •Cat allergic asthma (GINA 1, 2) associated with rhinitis and / or conjunctivitis symptoms triggered during an exposure to a cat.
- •Positive skin prick-test to cat allergen extract (wheal diameter >3 mm compared to the negative control) Specific immunoglobulin E (IgE) for cat allergen > 0.7 kU/L
- •Mild allergic asthma (GINA 1 or 2) not sensitized to cat allergen with associated rhinitis and/or conjunctivitis.
- •Negative skin prick-test and specific IgE for cat allergen
- •Positive skin prick-test and specific IgE for another allergen.
排除标准
- •Uncontrolled asthma, ACT asthma control questionnaire less than 20, in the last 4 weeks
- •Uncontrolled asthma 2 weeks after interruption of LABA
- •Long-term treatment by LABA, within 2 weeks prior to inclusion
- •Existence of a severe obstructive syndrome with FEV1 <70% of the theoretical value
- •Obstruction triggered by spirometric evaluations
- •Hospitalization for asthma or exacerbation in the last 4 weeks
- •Subjects treated with oral corticosteroids in the 4 weeks prior to inclusion in the study
- •History of severe acute asthma requiring hospitalization in intensive care or intubation
- •Subjects treated with biotherapy in the 4 months prior to inclusion in the study
- •Presence of a cat at home, or daily exposure to cat allergens
- •Desensitization to cat allergens in the last 6 months
- •Active tobacco: plus 10 cigarettes / day or tobacco history plus 10 PA
结局指标
主要结局
Determine the concentration of cat allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to cat.
时间窗: 10 hours: 4 hours of exposure in EEC then 6 hours post-exposure
The bronchial response is evaluated by measuring FEV1 value. Early asthmatic response (EAR) occurs when a 20 percent drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15 percent drop in FEV1 or 20 percent drop in peak flow is detected 1 to 6h after the EAR.
次要结局
- Evaluate the allergen concentration in the EEC(4 hours exposure in EEC)
- Evaluate the effect of the exposure on conjunctivitis symptoms(28 hours: 4 hours of exposure in EEC then 24 hours post-exposure)
- Evaluate the safety of allergenic exposure in EEC(28 hours: 4 hours of exposure in EEC then 24 hours post-exposure)
- Evaluate the specificity of the bronchial response(4 hours exposure in EEC)
- Evaluate the effect of the exposure on rhinitis symptoms(28 hours: 4 hours of exposure in EEC then 24 hours post-exposure)