NCT04641130已完成不适用
Validation and Reproducibility Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of Birch Pollen Allergen Inducing Conjunctivitis in Subjects Allergic to Birch Pollen.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Alyatec
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Determine the concentration of birch pollen allergen (in ng/m3 of Bet v1) necessary to induce a conjunctival response in at least 50% of subjects allergic to birch.
研究概览
简要总结
This is a single center open study designed to determine the concentration of airborne birch pollen inducing an allergic conjunctivitis response in individuals allergic to birch pollen, during allergen exposures in the Alyatec environmental exposure chamber (EEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Subjects with birch pollen rhinitis and conjunctivitis with:
- •A history of rhinoconjunctivitis for at least the last 2 consecutive pollen seasons.
- •A positive skin prick-test to birch (wheal diameter >6 mm compared to the negative control),
- •Specific immunoglobulin E (IgE) for birch> 0.1 kIU/l
- •Women of childbearing potential must have a negative pregnancy test during the entire study period with an effective means of contraception: oral contraceptives, intrauterine device, condom with spermicide for at least one month before inclusion in the study and for the duration of the study. At each study visit and each exposure on D1, a urine pregnancy test will be performed.
- •A positive conjunctival provocation test to birch during the screening visit at a dilution of 100IR/ml maximum
排除标准
- •Known asthmatic subjects allergic to birch pollen
- •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
- •Desensitization to birch pollen in the last 5 years
- •Uncontrolled chronic pathologies (hypertension, cardiac, respiratory, renal pathology).
- •Active autoimmune disease
- •Uncontrolled systemic hypertension
- •Subjects who participated in another clinical study in the three months prior to inclusion
- •Pregnancy and breast feeding
- •Inability to understand and act upon the information provided
结局指标
主要结局
Determine the concentration of birch pollen allergen (in ng/m3 of Bet v1) necessary to induce a conjunctival response in at least 50% of subjects allergic to birch.
时间窗: 4 hours exposure in EEC
A positive conjunctival response is defined by an Abelson score ≥ 5.
次要结局
- Study the effect of EEC birch pollen exposure on symptoms of rhino-conjunctivitis.(4 hours exposure in EEC)
- Measure the aerodynamic diameter of the particles carrying the allergens.(4 hours exposure in EEC)
- Evaluate the reproducibility of allergen exposure in the ALYATEC EEC(4 hours exposure in EEC)
- Study the effect of EEC birch pollen exposure on symptoms of conjunctivitis.(4 hours exposure in EEC)
- Measure the amount of particles carrying the allergens.(4 hours exposure in EEC)
- Evaluate changes in mitochondrial respiration(4 hours exposure in EEC)
- Study the effect of EEC birch pollen exposure on symptoms of rhinitis(4 hours exposure in EEC)
研究者
研究点 (2)
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