A Randomised, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of 5-grass Mix SLIT-drops in Adults With Grass Pollen-induced Rhinoconjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 44
- 主要终点
- Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)
研究概览
简要总结
This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)
The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.
The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.
详细描述
This trial is a 2 year, parallel-group, double-blind, placebo-controlled phase III trial to evaluate efficacy and safety of the 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis with or without asthma. Approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix SLIT-drops or placebo. The trial is conducted in several European countries.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥18 years on the day informed consent is obtained
- •A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
- •A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season
- •Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense
- •Positive skin prick test to Phleum pratense at screening
排除标准
- •Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods
- •Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
- •SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months
- •SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months
- •Ongoing treatment with any allergy immunotherapy product
- •Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening
研究组 & 干预措施
Placebo
Glycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily
干预措施: Placebo (Drug)
5-grass mix SLIT-drops
Grass mix sublingual allergy immunotherapy drops One single-dose container (0.5 ml) once daily. 50 SRU/day for five consecutive days followed by 150 SRU/day for five additional consecutive days. Maintenance: 300 SRU/day from day 11.
干预措施: 5-grass mix SLIT-drops (Drug)
结局指标
主要结局
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)
时间窗: During the 2nd PGPS (14 days)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
次要结局
- Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)(During the 2nd PGPS (14 days))
- Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)(During the 2nd EGPS (observed mean duration of approximately 9 weeks))
- Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)(During the 1st EGPS (observed mean duration of approximately 8 weeks))
- Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)(During the 2nd EGPS (observed mean duration of approximately 9 weeks))
- Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)(During the 1st PGPS (14 days))
- Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)(During the 1st PGPS (14 days))
- Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)(During the 1st EGPS (observed mean duration of approximately 8 weeks))
- Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)(During the 1st PGPS (14 days))
- Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)(During the 2nd PGPS (14 days))
- Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)(During the 1st EGPS (observed mean duration of approximately 8 weeks))
- Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)(During the 2nd EGPS (observed mean duration of approximately 9 weeks))
- Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)(During the 1st PGPS (14 days))
- Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)(During the 1st EGPS (observed mean duration of approximately 8 weeks))
- Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)(During the 2nd PGPS (14 days))
- Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)(During the 2nd EGPS (observed mean duration of approximately 9 weeks))