Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 628
- 主要终点
- Average Rhinoconjunctivitis Total Symptom Score
研究概览
简要总结
To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent
- •Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
- •Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
- •Total symptom score of the RRTSS during the previous pollen season greater than or equal to
- •Safety laboratory resuts within the references ranges
排除标准
- •Pregnancy, breast-feeding/lactation
- •Had received desensitisation treatment for grass pollen
- •Treatment by immunotherapy with another allergen within the previous 5 years
- •Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
- •Treated with beta-blockers or under continuous corticotherapy
研究组 & 干预措施
100 IR
100 IR grass pollen allergen extract tablet
干预措施: 100 IR grass pollen allergen extract tablet (Drug)
300 IR
300 IR grass pollen allergen extract tablet
干预措施: 300 IR grass pollen allergen extract tablet (Drug)
500 IR
500 IR grass pollen allergen extract tablet
干预措施: 500 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
时间窗: Pollen period (average of 32 days in the ITT set)
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