A Randomised, Double-blind, in Parallel Groups Placebo-controlled, Mono-centre, Phase I Study to Assess After Allergen Challenge in an Allergen Exposition Chamber the Effect and Its Time Course of Sublingual Immunotherapy (SLIT) Administered as 300IR Allergen-based Tablets Once Daily to Adults Suffering From Grass Pollen Rhinoconjunctivitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours
研究概览
简要总结
The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.
详细描述
The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.
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 18-50 years old
- •grass pollen rhinoconjunctivitis of at least 2 years.
- •positive specific skin prick test and a specific IgE dosage level of at least 0.70 kU/L at screening.
- •written consent
- •a positive response to the baseline challenge test (RTSS reaches 7 at one time-point at least during baseline challenge)
排除标准
- •Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study
- •Asthma requiring treatment other than short-acting beta-2 inhaled agonists.
- •Desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen.
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 of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours
时间窗: 4 months
The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (\]0-4\] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS \]0-4\] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.
次要结局
未报告次要终点