NCT01260753已完成2 期
Double Blind Randomised Placebo and Active Controlled, Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge to Allergic Patients Otherwise Healthy
Palau Pharma S.L.U.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Nasal and ocular symptoms scores after nasal allergen challenge
研究概览
简要总结
The purpose of this study is to explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule
- •Subjects with confirmed history of seasonal allergic rhinitis to grass pollen (by direct questioning of presence of positive skin prick test to pollen and History of Symptoms of allergic rhinitis) within the previous two years
- •Positive skin prick test to timothy grass pollen (wheal difference with negative control ≥ 3 mm) at screening
- •Subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (Symptoms worsening with respect to the response to the diluent challenge of ≥4 points in the total nasal symptom score [TNSS]) within one hour after last nasal allergen challenge
- •Screening and baseline FEV1 >80% predicted and FEV1/FVC > 70% predicted
排除标准
- •Symptoms of allergic rhinitis within 2 weeks prior to screening
- •Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods
- •Structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery
- •History of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or FEV1<80% of predicted at screening or baseline
研究组 & 干预措施
UR-63325
Experimental
干预措施: UR-63325 (Drug)
Fluticasone propionate nasal spray
Active Comparator
干预措施: Fluticasone propionate nasal spray (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Nasal and ocular symptoms scores after nasal allergen challenge
时间窗: 24 hours
次要结局
- Inflammatory parameters measured from nasal exudate(24 hours)
研究者
研究点 (1)
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