Comparison Between 4 Different Nasal Dilators: Objective vs Subjective Parameters
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Peak Nasal Inflammatory Flow
研究概览
简要总结
Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far, and would help the clinicians to advise the use of any of these dilators. From clinical experience, endonasal dilators are well supported and improve breathing better than the external dilators
详细描述
Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far,
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with nasal obstruction due to external nasal valve problems and with positive Cottle sign.
- •Age > 18 and < 60 years. Ability to give reliable information and written informed consent.
排除标准
- •Patients with nasal obstruction due to other endonasal anatomic deformities besides external nasal valve dysfunction.
- •Patients with rhinosinusitis and/or nasal polyps evaluated by nasal endoscopy. Patients with chronic lower airway disease like severe asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis and/or other conditions that interfere with the generation of a reliable Peak Nasal Inspiratory Flow (PNIF) result.
研究组 & 干预措施
Nasanita
Nasal Dilator
干预措施: Nasal dilator Nasanita (Device)
Breath Right
Nasal Dilator
干预措施: Nasal dilator Breath Right (Device)
Airmax
Nasal Dilator
干预措施: Nasal dilator Airmax (Device)
Nozovent
Nasal Dilator
干预措施: Nasal dilator Nozovent (Device)
结局指标
主要结局
Peak Nasal Inflammatory Flow
时间窗: 4 weeks
Change in Peak Nasal Inflammatory Flow between the 4 different dilators
次要结局
- preference(4 weeks)