Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes Using the Environmental Exposure Unit (EEU). Part 2.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Metabolomics
研究概览
简要总结
This clinical study will use the Environmental Exposure Unit (EEU) to generate allergic rhinitis symptoms in participants under controlled conditions, to collect well-characterized biological samples (urine and blood) before and after they develop these symptoms. The EEU provides the ability to control the timing, duration and levels of allergen exposure, and also other outside environmental factors, yielding ideal biologic samples for analysis with novel, cutting-edge molecular techniques. Results from the analysis of these unique allergic rhinitis samples should help determine if the technique of urine Nuclear Magnetic Resonance analysis could be a useful diagnostic tool in allergic rhinitis. IgE testing will be done on blood samples and compared to spin prick testing and symptoms of allergic rhinitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is a healthy, ambulatory male or female volunteer 18 to 55 years of age.
- •Participant has a history of Seasonal Allergic Rhinitis due to ragweed for the last two consecutive ragweed seasons.
- •Participant has a positive response (wheal diameter greater than or equal to 3 mm larger than diluent control) to a skin prick test to short ragweed allergen at screening or within 12 months of screening visit.
排除标准
- •Participant is a female that is pregnant, lactating or actively trying to become pregnant.
- •Participant is unable to comply with the washout periods for prohibited medications.
- •Participant is currently receiving allergen specific immunotherapy injections.
结局指标
主要结局
Metabolomics
时间窗: Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
Determine if urine NMR metabolic profiles from participants with allergic rhinitis will be significantly different from that of healthy participants (healthy controls were included in part 1 of the 2010 study) and if changes in urine NMR profile correlate with disease severity. NMR will be reported
次要结局
- IgE testing(Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.)
- Epigenetics(Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.)
研究者
Dr. Anne Ellis
Dr. Anne K. Ellis MD MSc FRCPC
Queen's University