A Randomised, Placebo Controlled, Four Period Crossover Study to Evaluate the Efficacy, Safety of Oral Repeat Doses of ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis in the Vienna Challenge Chamber.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Total Nasal Symptom Score
研究概览
简要总结
The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions.
详细描述
The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen administered at a fixed rate in an inhalation exposure chamber compared to the standard treatment Cetirizine 10mg under the same conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is aged between 18 and 65 years inclusive, and healthy with the exception of allergic rhinitis or mild asthma that does not require treatment and has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form.
- •The subject exhibits a moderate to severe response to grass pollen grains in the allergen challenge chamber at Screening.
排除标准
- •The subject on examination is found to have nasal structural abnormalities or nasal polyps; a history of frequent nose bleeds, nasal biopsy, nasal trauma or nasal surgery.
- •Pregnant or breast-feeding females.
研究组 & 干预措施
Experimental 2
Low dose ONO-4053
干预措施: Low dose ONO-4053 (Drug)
Experimental 1
High dose ONO-4053
干预措施: High dose ONO-4053 (Drug)
Cetirizine
10mg Cetirizine
干预措施: Cetirizine (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Total Nasal Symptom Score
时间窗: 4 months
To investigate the effect of repeat oral doses of ONO-4053 versus placebo on nasal symptoms elicited by allergen chamber challenge in subjects with seasonal allergic rhinitis.
次要结局
- Total Nasal Symptom Score(4 months)
- Total Ocular Symptom Score(4 months)
- Pharmacokinetics(Days 1 and 8)