NCT00623701已完成3 期
A Multicentre, Multinational, Placebo-controlled, Double-blind, Randomized Study to Evaluate Efficacy and Safety of a Perennial, Sublingual, Specific Immunotherapy in Patients With Rhinoconjunctivitis With/Without Controlled Asthma Caused by Grass Pollen
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Symptom and Medication Score
研究概览
简要总结
Efficacy and Safety from a high-dosed sublingual grass pollen preparation
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
- Double (Participant, Investigator)
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
- •Allergic rhinoconjunctivitis attributable to grass pollen
- •Positive SPT
- •Positive EAST
- •Positive provocation Test
排除标准
- •Serious chronic disease
- •other perennial allergies
研究组 & 干预措施
1
Placebo Comparator
sublingual placebo preparation
干预措施: Allerslit forte (Biological)
2
Experimental
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose
干预措施: Allerslit forte (Biological)
结局指标
主要结局
Symptom and Medication Score
时间窗: Grass pollen season 2009
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen MixtureGrass Pollen AllergyNCT00264459Allergopharma GmbH & Co. KG160
已完成
3 期
Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)ConjunctivitisRhinoconjunctivitisRhinitisAllergyNCT00562159ALK-Abelló A/S439
已完成
2 期
Efficacy and Safety of Grass Pollen Sublingual ImmunotherapyAllergic RhinoconjunctivitisNCT00567346Artu Biologicals605
已完成
3 期
A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)ConjunctivitisRhinitis AllergicNCT01385371ALK-Abelló A/S1,501
已完成
3 期
Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in ChildrenAllergic RhinoconjunctivitisNCT00841256Allergopharma GmbH & Co. KG207