Evaluation of the Utility of an Environmental Exposure Chamber (EEC) for Assessing Efficacy of Specific Immunotherapy (SIT) in Pivotal Clinical Trials
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Total Symptom Score (TSS)
研究概览
简要总结
The study will explore how allergy symptoms experienced during the grass pollen season compare to symptoms experienced in the Environmental Exposure Chamber (EEC).
There are 2 treatments in this study. Both treatments are injected under the skin. Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before the grass pollen season begins which may lead to decreased sensitivity and reduced allergy symptoms during the grass season. Placebo treatment does not contain grass pollen mixture, and is not expected to reduce allergic symptoms overtime.
详细描述
This is a Phase II trial, with a one year observational/baseline phase followed by a one year double-blind placebo-controlled, randomized, treatment phase. Approx. 137 grass pollen-allergic subjects and 20 non-allergic subjects will be enrolled in the baseline phase of the study. The primary objective of the trial is to investigate the relationship between allergy symptoms experienced by subjects (allergic and non-allergic) upon exposure to grass pollen-allergen in the EEC and the allergy symptoms experienced by subjects during the grass pollen season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without allergic asthma
- •positive skin prick test
- •specific IgE ≥ 0.70 kU/L to mixture of grass pollen allergens
- •symptom score of at least 4 per day during the week following the peak-pollen count in the baseline season
排除标准
- •undergone previous specific immunotherapy with grass pollen allergens in any formulation less than 5 years prior to the screening date
- •currently undergoing any sort of immunotherapy, or has ever undergone specific immunotherapy with unknown allergen
- •allergens which are expected to interfere with the grass pollen season
- •uncontrolled or partly controlled asthma
- •patients with contraindications for SIT
研究组 & 干预措施
Placebo
Placebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it.
干预措施: Placebo (Drug)
Allergovit 6-grasses immunotherapy
Immunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised.
干预措施: Allergovit 6-grasses (Biological)
结局指标
主要结局
Total Symptom Score (TSS)
时间窗: 1 year
Analysis of the relationship between different methods of measurement of efficacy of SIT. The AUC of the Total Symptom Score (TSS) as primary endpoint assessed in an EEC after preseasonal treatment
Rhinoconjunctivitis Symptom and Medication Score (RC-SMS)
时间窗: Grass pollen season from March until July (approx. 11 weeks avarage)
The AUC of the Rhinoconjunctivitis Symptom and Medication Score (RC-SMS) assessed as primary endpoint during the natural grass pollen season (field-based)
Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS)
时间窗: Grass pollen season from March until July (approx. 11 weeks avarage)
The AUC of the Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) assessed as primary endpoint during the natural grass pollen season (field-based)
次要结局
- Symptoms (by TSS, RC-SMS, ma-RC-SS) in non-allergic subjects(1 year)