Validation Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of House Dust Mite Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Mite
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Alyatec
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Determine the concentration of HDM allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to HDM
研究概览
简要总结
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, 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 house dust mite 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（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
- •Positive metacholine test
- •FEV1 value > 70% of theoretical FEV1 value
- •Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
- •Mild allergic asthma to HDM (GINA 1 or 2) with associated rhinitis and/or conjunctivitis.
- •Positive skin prick-test to Dpt and Df (wheal diameter >5 mm compared to the negative control)
- •Specific immunoglobulin E (IgE) for Dpt and Df > 0.7 kU/L
- •Mild allergic asthma (GINA 1 or 2) not sensitized to HDM with associated rhinitis and/or conjunctivitis.
- •Negative skin prick-test and specific IgE for Dpt and Df.
- •Positive skin prick-test and specific IgE for another allergen.
排除标准
- •Uncontrolled asthma
- •Asthma Control Test (ACT) < 20/25 in 4 weeks prior to EEC exposure
- •Use of oral corticosteroids in the 4 weeks preceding inclusion in the study
- •Use of biotherapy in the 4 months preceding inclusion in the study
- •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
- •History of Acute Severe Asthma requiring hospitalization in intensive care or intubation
- •Desensitization to dust mite allergens in the last 5 years
- •Sensitization to allergens in the indoor environment (cat allergens or molds) with obvious exposure to these allergens
- •Active tobacco: plus 10 cigarettes / day and tobacco history of +10 PA
- •Uncontrolled systemic arterial hypertension
- •Recent myocardial infarction (<3 months)
- •Recent stroke (<3 months)
- •Known arterial aneurysm
- •Epilepsy under treatment
- •Progressive tumor pathology
- •Chronic renal pathology
- •Hypersensitivity to one of the excipients used
- •Subjects who participated in another clinical study in the three months prior to inclusion
结局指标
主要结局
Determine the concentration of HDM allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to HDM
时间窗: 10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure.
The bronchial response is evaluated by measuring FEV1 value during EEC exposure. Early asthmatic response (EAR) occurs when a 20% drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15% drop in FEV1 or 20% drop in peak flow is detected 1 to 6h after the EAR.
次要结局
- Evaluate the specificity of the bronchial response(4 hours of exposure in EEC)
- Evaluate the safety of allergenic exposure in EEC(28 hours: 4 hours of exposure in EEC then 24 hours post-exposure)
- Evaluate the metrology of the EEC(4 hours of 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)
- Evaluate the effect of the exposure on conjunctivitis symptoms(28 hours: 4 hours of exposure in EEC then 24 hours post-exposure)