An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,073
- 试验地点
- 2
- 主要终点
- Week 2 likelihood of continued use of RHINIX after study end.
研究概览
简要总结
This study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in Denmark.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Motivated to try a different treatment approach to seasonal allergic rhinitis (documented by answering the call-out by Astma-Allergi Danmark)
- •Indicates having seasonal allergic rhinitis to grass via online questionnaire
- •Informed consent (by email acceptance after having received information on the trial)
- •Assess to internet and email
排除标准
- •Improper fit of the Rhinix™ device
结局指标
主要结局
Week 2 likelihood of continued use of RHINIX after study end.
时间窗: 1 assessment at the end of the 2nd week of use.
In week 2: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.
Week 1 likelihood of continued use of RHINIX after study end.
时间窗: 1 assessment at the end of the 1st week of use.
In week 1: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.
次要结局
- Week 1: RHINIX Control(One assessment at the end of the 1st week of use)
- Week 2: RHINIX Control(One assessment at the end of the 2nd week of use.)
- Week 2 satisfaction with RHINIX(One assessment at the end of the 2nd week)
- Week 1 Satisfaction with RHINIX(1 assessment at the end of the 1st week)