Determination of Grass Pollen Allergen Concentration Inducing Rhinoconjunctivitis Symptoms in Subjects Allergic to Grass Pollen in ALYATEC Allergen Exposure Chamber
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Alyatec
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Optimal concentration of grass allergens (Phl p 5 in ng/m3) to induce a positive rhino-conjunctivitis response in subjects allergic to grass pollen during 3 hours of exposure to grass pollen allergens in the ALYATEC Environmental Exposure Chamber (EEC)
研究概览
简要总结
The aim of this study is to determine the optimal concentration of grass pollen allergens inducing rhinoconjunctivitis in subjects allergic to grass pollen in ALYATEC allergen exposure chamber.
Four concentrations of grass pollen allergen (Phl p 5) are tested during 3-hour exposures: 0, 30, 60 and 90 ng/m3.
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)
盲法说明
The grass pollen allergen (Phl p 5) concentrations corresponding to concentrations A, B, C and D are assigned randomly by the technician and the pharmacist of the exposure chamber so that neither the investigator, the participants nor the clinical and medical staff are aware of the exposure doses.
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
- •Main Inclusion Criteria:
- •Subjects with symptoms of allergic rhinoconjunctivitis to grass pollen without associated asthma, requiring anti-allergic treatment for at least 2 consecutive pollen seasons;
- •Subjects with positive skin prick tests to grass pollen extracts (Phleum pratense): papule diameter ≥ 5 mm compared to the negative control (NaCl reaction < 2 mm));
- •Subjects with Phl p 5 specific recombinant Immunoglobulin E ≥ 0.70 kIU/L;
- •Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value at screening and before allergenic exposures;
- •Women of childbearing age must have a negative pregnancy test at screening and before exposure visits;
排除标准
- •Specific immunotherapy (SIT) to grass pollen allergens for more than one month in the 3 years preceding the screening visit;
- •Ongoing specific immunotherapy to another allergen
- •History of anaphylaxis following exposure to grass pollen or grass SITs;
- •Ear, Nose & Throat or ocular surgical intervention in the 6 months preceding inclusion;
结局指标
主要结局
Optimal concentration of grass allergens (Phl p 5 in ng/m3) to induce a positive rhino-conjunctivitis response in subjects allergic to grass pollen during 3 hours of exposure to grass pollen allergens in the ALYATEC Environmental Exposure Chamber (EEC)
时间窗: 0 to 3 hours
The optimal concentration of grass pollen allergens Phl p 5 in ng/m3 will be determined by evaluating the Area Under the Curve (AUC) of the rhino-conjunctivitis TSS (Total Symptoms Score). The value of the TSS varies from 0 (no symptom) to 24 (highest symptoms)
次要结局
- Time to obtain a rhino-conjunctivitis response during the 3 hours of exposure to grass pollen allergens in the ALYATEC EEC(0 to 3 hours)
- Frequency of bronchial response during 3 hours of exposure in the ALYATEC EEC(0 to 3 hours)
- Optimal concentration of grass allergens (Phl p 5 in ng/m3) to induce a positive rhinitis response in subjects allergic to grass pollen during 3 hours of exposure to grass allergens in the ALYATEC Environmental Exposure Chamber (EEC)(0 to 3 hours)
- Use of concomitant medications during and after exposures in the EEC ALYATEC(0 to 24 hours)