A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of Two Dosing Regimens of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets 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
- 633
- 试验地点
- 1
- 主要终点
- Average Adjusted Symptom Score (AAdSS)
研究概览
简要总结
A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged 18 to 50 years
- •Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons
- •Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens
- •A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)
排除标准
- •Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.
- •Asthma requiring treatment other than beta-2 inhaled agonists.
- •Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.
研究组 & 干预措施
300 IR (4M)
300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
干预措施: 300 IR (4M) (Drug)
300 IR (2M)
300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
干预措施: 300 IR (2M) (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 33.8 days) of Year 3
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the Year 3 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