A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 381
- 试验地点
- 6
- 主要终点
- Average Adjusted Symptom Score (AAdSS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
详细描述
To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:
- The Average Adjusted Symptom Score (AASS).
To document the safety of the treatment.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Positive SPT to any other seasonal allergens present during the grass pollen season
- •Patients with clinically significant confounding symptoms of allergy to other allergens
- •Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
- •Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).
研究组 & 干预措施
300 IR
300 IR grass pollen allergen extract tablet
干预措施: 300 IR (Drug)
Placebo
Placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Average Adjusted Symptom Score (AAdSS)
时间窗: Pollen period (average of 32.1 days)
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the pollen period while on treatment, 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). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome.
次要结局
未报告次要终点