Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Nasal symptoms severity
研究概览
简要总结
As the medical device is CE marked, the objective of this study is to provide performance and safety data on SULFEX 13081.22 nasal spray as close as possible to the routine care.
详细描述
Every day, people breathe large amounts of air which contain all kinds of particles. Nasal cavities are the first site of airway protection against airborne particles. The mucociliary apparatus (a layer of tiny moving hairs and mucus which covers the mucous membrane inside the nose) is the first line of defence of the upper airways and helps to eliminate these particles. If this defence mechanism is altered, it may cause nasosinusal damage or irritation and be unable to protect the respiratory system.
Moreover, external factors such as pollution or dry air may affect the function of the nose. The same is true for chronic and/or recurrent infections. These various factors can cause irritation or dryness of the nasal mucosa, often causing inflammation with feelings of congestion, discomfort or burning of the nasal mucosa, sometimes with bleeding or painful crusting.
SULFEX 13081.22 is a nasal spray, CE marked and commercialized since 2014. SULFEX spray soothes, restores and provides long-lasting/intense hydration of uncomfortable, painful or sore nasal mucosa caused by excessive dryness. It also contributes towards cell regeneration for faster healing and optimum relief and protects against new external attacks.The anti-reflux valve system prevents any contamination of the solution, even after the bottle has been opened, which means the formula remains 100% aseptic.
As the medical device is CE marked, the objective of this study is to provide performance and safety data on SULFEX 13081.22 nasal spray as close as possible to the routine care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 18 years of age.
- •Patient voluntarily buying the spray and using it for him/herself.
- •Patient with nasal dryness and/or nasal irritation.
- •Patient informed of the study, who gave its express consent (free, informed, written) before any specific procedure to the study.
- •Patient meeting study's requirements regarding follow-up schedule and questionnaires filling.
- •Patient affiliated to a social security scheme.
排除标准
- •Patient currently taking corticosteroids or antibiotics or antihistamines or Nonsteroidal anti-inflammatory drugs (NSAIDs) or topical decongestants or systemic decongestants
- •Patient currently using other nasal sprays, nasal pumps, nasal irrigation/lavage device, or oils, creams or gels into the nose.
- •Patient deprived of freedom or subject to legal protection measures.
- •Pregnant or breastfeeding woman.
结局指标
主要结局
Nasal symptoms severity
时间窗: 6 days
Severity of the following nasal symptoms will be compared before and 6 days after spray use on a 7-point scale basis. * Nasal irritation * Nasal dryness Performance on Irritation and Dryness will be verified if there is a decrease of at least 0.5 point on at least one of the two symptom scores between Day 0 and Day 6. This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.
次要结局
- Product attributes(6 days)
- Onset of relief(immediate or semi-immediate)
- Duration of relief (long lasting).(6 days)
- Medical device usability(6 days)
- Nasal symptoms relief/change(6 days)
- Safety data on SULFEX 13081.22 nasal spray(6 days)
- Performance of SULFEX 13081.22 nasal spray(6 days)
- Previous nasal state of well-being assessment(6 days)
- Patient satisfaction(6 days)