Efficacy of Puressentiel Protective Nasal Spray on Symptoms and Inflammation in Patients With in Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 主要终点
- Change in concentration of IL-13 in the nasal lavage will be assessed
研究概览
简要总结
This study is a proof o concept aiming to determine the efficacy of Puressentiel nasal protective spray (PNPS) in patients with allergic rhinitis.
Cross over study, with a nasal provocative test (NPT) in patients with allergic rhinitis sensitized to grass pollen. A day 0 (first NPT) the following outcomes are recorded: allergic Rhinitis control test (ARCT) and Inspiratory nasal peak flow (INPF) before and 30 min after the NPT. Nasal lavage is performed 30 min after the NPT and 3 cytokines (IL4, IL5 and IL13 are measured by ELISA.
An other NPT is performed at day 30 and the same outcomes measured.
30 min before NPT 2 nasal sprays of PNPS are administered in each nostril in a randomized manner and cross over, the patient being is own control.
The primary outcomes ins the IL4, IL5 and IL13 concentrations in the nasal lavage. ARCT and INPF are the secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with diagnostic of allergic rhinitis sensitized to grass pollen for more than one year with or without associated asthma
排除标准
- •patients sensitized to a perrianual allergen
- •patients with viral infection 4 weeks before inclusion
- •patients with severe non controlled asthma
- •patients with chronic sinusitis
- •pregnancy or breast feeding
- •patients with hypersensitivity to essential oil (eucalyptus radie)
- •epileptic patient
- •patients treated with nasal corticosteroid or anti-histamine
结局指标
主要结局
Change in concentration of IL-13 in the nasal lavage will be assessed
时间窗: measurements at day 1 and day 30
measurement by ELISA
次要结局
- Change in Allergic Rhinitis Control test (ARCT) will be assessed(Day 1 and day 2)
- Change in concentration of IL-5 in the nasal lavage will be assessed(Day1 and Day30)
- Change in concentration of IL-4 in the nasal lavage will be assessed(Day1 and Day 30)
- Change in Nasal Inspiratory Peak Flow will be assessed(Day 1 and Day 30)