Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- changes in SARS (seasonal allergic rhinitis symptoms)
研究概览
简要总结
The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.
详细描述
Patients allergic to the specific pollen are divided into two groups randomly. One group is being administered Lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. Methods used for evaluation are: SARS questionnaire(seasonal allergic rhinitis symptoms), Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) skin Prick test, specific IgE and IgG, eosinophilia in nasal secretion. Methods used for follow up safety include side effects report, physical examination and vital signs.
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
- Double (Participant, Investigator)
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
- •history of seasonal allergic rhinitis symptoms to pollen
- •positive skin prick test to pollen
- •negative history of seasonal allergic asthma
- •male or female older than 18
- •female participants must use appropriate contraception
- •able to comply to study procedures
排除标准
- •pregnancy
- •alcohol or drug abuse
- •subject receiving antihistamines , immunotherapy or on hyposensibilisation
结局指标
主要结局
changes in SARS (seasonal allergic rhinitis symptoms)
时间窗: 6 weeks
changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)
时间窗: 6 weeks
changes in specific IgE
时间窗: 6 weeks
changes in specific IgG
时间窗: 6 weeks
次要结局
- Prick test change(6 weeks)
- change in eosinophilia in nasal secretion(6 weeks)