A Double-blind Placebo-controlled Dose-response Study for Evaluation of Safety and Efficacy of Immunotherapy With a Cocktail of Recombinant Major Allergens of Timothy Grass Pollen (Phleum Pratense) Adsorbed to Aluminium Hydroxide in Patients With IgE-mediated Allergic Rhinitis/Rhinoconjunctivitis With or Without Bronchial Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Systemic reaction (according to Tryba)
研究概览
简要总结
Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •main symptoms of allergic rhinitis/rhinoconjunctivitis with or without controlled asthma against grass pollen allergens
- •positive SPT
- •positive EAST
- •positive specific provocation test
排除标准
- •serious chronic diseases
- •other perennial allergies
研究组 & 干预措施
40 μg rPhleum Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
干预措施: rPhleum (Biological)
Placebo
Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.
干预措施: placebo (Drug)
20 μg rPhleum Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)
干预措施: rPhleum (Biological)
80 μg rPhleum Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
干预措施: rPhleum (Biological)
120 μg rPhleum Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
干预措施: rPhleum (Biological)
结局指标
主要结局
Systemic reaction (according to Tryba)
时间窗: uptitration phase
Number of patients with at least one systemic reaction (according to Tryba Grade 1-4) with possible, probable or definite relationship to the study medication determined at the end of the uptitration phase.
次要结局
- Late Phase Reactions(before and at the end of the double-blind phase)