NCT00697281已完成2 期
A Dose Finding Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis.
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
- Oxagen Ltd
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total nasal symptom score (TNSS)
研究概览
简要总结
The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis
详细描述
This will be a randomised, double blind, placebo controlled, parallel group evaluation of OC000459 given orally for eight days. Four dose levels will be studied and compared to placebo. They will be studied in treatment groups of 18 to 21 subjects. The placebo group will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks. There will be a follow up one to three weeks after the last dose of study drug.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
- •Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening.
- •Acceptable contraception includes the use of TWO of the following:
- •oral contraception (i.e. the Pill);
- •intrauterine device (an IUD or 'Coil');
- •barrier contraception (i.e. condoms or diaphragm/cap);
- •transdermal patch
排除标准
- •Medical conditions likely to affect the outcome of the study.
- •Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee.
- •Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age).
- •Immunotherapy treatment course in the past 28 days
- •Use of inhaled or local corticosteroids in the past 28 days.
研究组 & 干预措施
1
Experimental
Dose level 1
干预措施: OC000459 (Drug)
2
Experimental
Dose level 2
干预措施: OC000459 (Drug)
3
Experimental
Dose level 3
干预措施: OC000459 (Drug)
4
Experimental
Dose level 4
干预措施: OC000459 (Drug)
5
Experimental
Dose level 5
干预措施: Placebo (Drug)
结局指标
主要结局
Total nasal symptom score (TNSS)
时间窗: After 8 days of treatment
次要结局
- Other symptom scores of allergic rhinitis(After 8 days of treatment)
研究者
研究点 (1)
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