Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge. Impact on Bronchial Hyperresponsiveness and the Effect of Intranasal Corticosteroid Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Serum Eosinophil Cationic Protein (ECP)
研究概览
简要总结
Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.
The study was randomised, placebo-controlled double-blind in patients, monoallergic to grasspollen, presenting symptoms of rhinitis and asthma during season.
Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of treatment intranasal allergen challenge was performed. Measurements were performed during the full study period.
The study was performed out of pollen season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •monoallergy to grass
- •symptoms of allergic rhinitis for at least the two most recent grasspollen seasons
- •asthma symptoms of asthma for at least two of the four most recent grasspollen seasons
- •age 18 or older
排除标准
- •pregnancy or lactation
- •fertile women, not sterilised or using sufficient anticonception
- •Corticosteroid treatment (parenteral, oral, inhaled or intranasal) within two months prior to enrolment
- •Any other disease, condition or treatment, which to the discretion of the investigator has the potential to interfere with study results
研究组 & 干预措施
INCS
Fluticasone propionate 400 microgram daily
干预措施: INCS (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Serum Eosinophil Cationic Protein (ECP)
时间窗: 1 month
次要结局
- Serum Eosinophil Peroxidase (EPO)(1 month)
- Nasal lavage Eosinophil Cationic Protein (ECP)(1 month)
- Nasal lavage Eosinophil Peroxidase (EPO)(1 month)
- Blood Eosinophils(1 month)