NCT01105949已完成1 期
An Evaluation of Two Novel Breathe Right Nasal Strip Prototypes on Nasal Patency
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry
研究概览
简要总结
The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history
排除标准
- •Currently experiencing cold or flu
- •History of perennial or allergic rhinitis or rhinitis medicamentosa
- •Evidence of nasal polyps as documented by anterior rhinoscopy
- •Evidence of significant nasal tract structural malformations including a severe deviated septum (where subjects are indicated for surgery) or a concha bullosa as documented by anterior rhinoscopy
- •Visible open sores, sunburn, irritation, eczema or chronic skin condition on the face to nose
- •Bacterial sinusitis infection during 2 weeks prior to entry in the baseline phase of the study
- •Any other condition that in the opinion of the investigator would have an affect on nasal breathing
- •Use of any product containing menthol within two hours prior to any subjective measures involved in the study
- •Had an allergic contact dermatitis on the face within 30 days prior to entry
- •History of chronic or active skin or other immunologic (rheumatoid, psoriasis) disease
- •History of skin cancer
- •Use of antibiotics or alpha adrenergic drugs (all forms) within 1 week prior to entry in the baseine phase of the study
- •Use of glucocorticosteroids (all forms) within 1 month prior to entry in the baseline phase of the study
- •Any current treatment which in the opinion of the investigator will affect nasal congestion
研究组 & 干预措施
NexGen AB 2R11
Experimental
NexGen AB 2R11
干预措施: NexGen AB 2R11 (Device)
Marketed nasal strip
Other
Marketed nasal strip
干预措施: Marketed nasal strip (Device)
NexGen JB Organic PET/PE
Experimental
NexGen JB Organic PET/PE, prototype nasal dilator strip
干预措施: NexGen JB Organic PET/PE (Device)
结局指标
主要结局
Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry
时间窗: baseline to within 2 hours post application
Change from baseline in total nasal volume of the nose using acoustic rhinometry
时间窗: baseline to within 2 hours post application
次要结局
- Nasal airway breathing as measured by Posterior Rhinomanometry(Baseline to 2 hours)
- Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF)(Baseline to 2 hours)
- Subjective perceptions of airway breathing(Baseline to 2 hours)
研究者
研究点 (1)
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