A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Average Rhinoconjunctivitis Total Symptom Score (ARTSS)
研究概览
简要总结
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged 5 to 17 years.
- •Written consent / assent.
- •Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- •Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
- •Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.
排除标准
- •Patients who have received any desensitisation treatment for grass pollen.
研究组 & 干预措施
300 IR
300 IR grass pollen allergen extract tablet
干预措施: 300 IR grass pollen allergen extract tablet (Drug)
Placebo
Placebo tablet
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Average Rhinoconjunctivitis Total Symptom Score (ARTSS)
时间窗: Pollen period (average of 38.6 days)
Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome.
次要结局
未报告次要终点