Post-marketing Clinical Investigation to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 2
- 主要终点
- URTI population : Effectiveness to improve nasal congestion
研究概览
简要总结
The brief of this observational study is to evaluate usage, efficacy, safety and patient satisfaction of a range of hypertonic seawater-based decongestant nasal sprays in general population.
The main questions it aims to answer are:
- Usage,
- Efficacy,
- Safety,
- Satisfaction, in real-life usage with children, adults and pregnant or breastfeeding women. Participants will use the nasal spray as usual habits and complete daily questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject coming to pharmacy for spontaneous purchase of one of the medical device under investigation.
- •Subject willing to buy one of the medical device under investigation following advice from pharmacist, general practitioner or any other health care professionals.
- •Adult and children from 3 years old in compliance with the information for use.
- •Subject presenting moderate nasal congestion or more.
- •Subject agreeing to follow the study requirements during the whole study period.
- •Subject having daily access to internet in order to answer online questionnaire.
- •Subject able to understand verbal and written local language and in capacity to fill-in questionnaire himself.
- •Subject able to give inform consent.
排除标准
- •Subject with contraindications according to the information for use.
- •Hypersensitivity or know allergy to any component of the product.
- •Subject taking part in another clinical study or being in the exclusion period of another clinical study.
- •Subject already included once in this study or having a family member already included in this study for the same indication.
- •Vulnerable subject (except children, pregnant and breastfeeding women).
结局指标
主要结局
URTI population : Effectiveness to improve nasal congestion
时间窗: URTI: 3 days
URTI: Assess effectiveness to improve nasal congestion in real world usage (6-point Likert scale) 6-point-Likert scale: 0 (None) - 1 (Very mild) - 2 (Mild) - 3 (Moderate) - 4 (Strong) - 5 (Very strong). Higher score means a worse outcome
AR population: Effectiveness to improve nasal congestion
时间窗: AR: 7 days
Allergic Rhinitis (AR) : Assess effectiveness to improve nasal congestion in real world usage (6-point Likert scale) 6-point-Likert scale: 0 (None) - 1 (Very mild) - 2 (Mild) - 3 (Moderate) - 4 (Strong) - 5 (Very strong). Higher score means a worse outcome
次要结局
- Effectiveness to improve overall nasal symptoms (night-time)(AR: Day 0 - Day 21)
- Usage(AR: Day 0 - Day 21)
- Tolerance(AR: Day 10 + Day 21)
- Safety of the medical device(AR: Day 0 - Day 21)
- Patient satisfaction(AR: Day 10 + Day 21)
- Sensory profile(AR: Day 10 + Day 21)
- Effectiveness to improve overall nasal symptoms (daytime)(AR: Day 0 - Day 21)
- Effectiveness to improve quality of life(AR: Day 0 - Day 21)
- Relief of nasal symptoms(URTI: Day 1 - Day 14)
- Onset of action & Duration(AR: Day 0 - Day 21)