... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Changes of Symptom-Medication-Score
研究概览
简要总结
Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.
详细描述
Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.
Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.
In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4 - <12 years (at the time of inclusion)
- •Positive SPT
- •Positive EAST
- •Positive CPT
排除标准
- •Serious chronic diseases
- •Other perennial allergies
研究组 & 干预措施
Immunotherapy
Grass pollen allergens in a water/glycerol solution
干预措施: Grass pollen allergens in a water/glycerol solution (Biological)
Placebo
Water/glycerol solution with phosphate buffered saline
干预措施: Placebo (Drug)
结局指标
主要结局
Changes of Symptom-Medication-Score
时间窗: After 1 year of treatment
The change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment.
次要结局
- Evaluation of the documentation of adverse events (AEs)(Entire treatment period)
