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临床试验/NCT00841256
NCT00841256已完成3 期

... 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

Allergopharma GmbH & Co. KG1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Grass pollen allergens in a water/glycerol solution

干预措施: Grass pollen allergens in a water/glycerol solution (Biological)

Placebo

Placebo Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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