NCT07262450招募中不适用
Real-word Study to Assess Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,065
- 试验地点
- 32
- 主要终点
- Real-life effectiveness to improve nasal symptoms in case of acute and chronic sinonasal pathologies.
研究概览
简要总结
The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays.
The main questions it aims to answer are:
- Efficacy,
- Safety,
- Usage,
- Satisfaction, in real-life usage among infants, children, adults and pregnant or breastfeeding women suffering from acute and chronic sinonasal pathologies. The 4 medical devices under investigation will be used in accordance with their intended use, target populations and medical indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's age and medical condition in compliance with the intended use and population
- •Subjects who, from the investigator's judgement, should benefit from nasal wash in accordance with routine medical practice
- •Subjects with at least two nasal symptoms of intensity ≥ 3 (6 modalities intensity SNOT-22 rating-scale) among the following:
- •Nasal blockage/nasal congestion/ stuffy nose;
- •Runny nose;
- •Need to blow/clear the nose;
- •Sneezing;
- •Thick nasal discharge/secretions;
- •Decreased sense of smell /taste (replaced by "noisy breathing/mouth breathing" for infants)
- •Subjects with impaired nasal breathing (score ≥ 3, 6-modalities intensity rating-scale), induced by the presence of nasal symptoms
- •For acute indications (only): subjects with symptoms started not later than 72 hours prior to enrolment (Day 0).
- •For allergic rhinitis indication: perennial allergic rhinitis with and without seasonal allergic rhinitis
- •For post-surgery indication: septoplasty and rhinoseptoplasty.
- •Subject/parent willing to perform nasal wash following advices received from HCPs.
- •Subjects (or parents for babies and children) agreeing to follow the study requirements during the whole study period (up to 3 months).
- •Subject (or parent for baby and children) able to understand verbal and written local language and in capacity to fill-in questionnaire by himself.
- •Subject having daily access to internet to answer online questionnaire.
- •Subject or Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
- •Subject affiliated to the health social security system or beneficiary of an equivalent system
- •Non-inclusion criteria:
- •Subject with contraindications according to each IFU.
- •Hypersensitivity or known allergy to any component of the investigational products.
- •Subject taking part in another clinical study or being in the exclusion period of another clinical study.
- •Subject already using nasal wash to manage his nasal symptoms.
- •Subject already included once in the study.
- •Subject with a member of his household already included in the study if still in the follow-up phase.
- •Subject deprived of liberty by administrative or judicial decision or under legal guardianship.
排除标准
- 未提供
结局指标
主要结局
Real-life effectiveness to improve nasal symptoms in case of acute and chronic sinonasal pathologies.
时间窗: From Day 0 to Day 5 (acute indications: URTI, COVID-19, bronchiolitis) From Day 0 to Day 14 (chronic indications: allergic rhinitis, chronic rhinosinusitis, post-surgery)
Change from baseline in nasal symptom intensity following initiation of nasal wash, based on the modified SNOT-22 rhinologic score. 6-modalities intensity Likert scale: 0=No problem; 1= Very mild problem; 2=Mild or slight problem; 3= Moderate problem; 4=Severe problem; 5=Problem as bad as it can be.
次要结局
- Real-life effectiveness to reduce the intensity of individuals symptoms(From Day 0 to Day 14)
- Real-life effectiveness to reduce the intensity of additional extra nasal symptoms(From Day 0 to Day 14)
- Real-life effectiveness to reduce the intensity of eyes symptoms(From Day 0 to Day 14)
- Real-life effectiveness to reduce the daily intensity of symptoms(From Day 0 to Day 14)
- Real-life effectiveness to reduce the overall intensity of symptoms(From Day 0 to Day 14)
- Real-life effectiveness to reduce the frequency of sneezing(From Day 0 to Day 14)
- Real-life effectiveness to reduce the frequency of nose blowing(From Day 0 to Day 14)
- Real-life effectiveness to reduce the frequency of cough(From Day 0 to Day 14)
- Real-life effectiveness to relieve individual symptoms - Evolution(From Day 0 to Day 14)
- Real-life effectiveness to relieve individual symptoms(From Day 0 to Day 14)
- Real-life effectiveness to relieve individual symptoms - 1st relief(From Day 0 to Day 14)
- Real-life effectiveness to improve nasal breathing(From Day 0 to Day 14)
- Real-life effectiveness to improve nasal breathing - Onset(From Day 0 to Day 14)
- Real-life effectiveness to improve nasal breathing - Duration(From Day 0 to Day 14)
- Real-life effectiveness to improve nasal breathing - Time interval(From Day 0 to Day 14)
- Real-life effectiveness to improve nasal blowing/removal of secretions(From Day 0 to Day 14)
- Real-life effectiveness to improve quality of secretions(From Day 0 to Day 14)
- Real-life effectiveness to improve quality of life(From Day 0 to Day 14)
- Real-life effectiveness to improve quality of life - Energy(From Day 0 to Day 14)
- Real-life effectiveness to improve quality of life - Daily activities(From Day 0 to Day 14)
- Real-life effectiveness to improve quality of life - Feeding difficulties(From Day 0 to Day 14)
- Real-life effectiveness to improve quality of life - Baby and young child(From Day 0 to Day 14)
- Real-life effectiveness to improve quality of life of the family(From Day 0 to Day 14)
- Real-life effectiveness to limit nasal symptoms during winter and allergy seasons.(From Day 15 to 3 months)
- Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons.(From Day 15 to 3 months)
- Real-life effectiveness to limit nasal symptoms during winter and allergy seasons(From Day 15 to 3 months)
- Real-life effectiveness to limit nasal symptoms during winter and allergy seasons - Sneezing frequency.(From Day 15 to 3 months)
- Real-life effectiveness to limit nasal symptoms during winter and allergy seasons - Nose blowing.(From Day 15 to 3 months)
- Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Eyes symptoms.(From Day 15 to 3 months)
- Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons .(From Day 15 to 3 months)
- Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Cough, snoring, wake-up at night.(From Day 15 to 3 months)
- Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Acute respiratory infections.(From Day 15 to 3 months)
- Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Allergic rhinitis episodes.(From Day 15 to 3 months)
- Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Asthma episodes.(From Day 15 to 3 months)
- Real-life effectiveness to improve nasal breathing quality during winter and allergy seasons.(From Day 15 to 3 months)
- Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons.(From Day 15 to 3 months)
- Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons - Energy.(From Day 15 to 3 months)
- Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons - Well-being & global health status(From Day 15 to 3 months)
- Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons - Daily activities.(From Day 15 to 3 months)
- Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons - Practical problems.(From Day 15 to 3 months)
- Real-life effectiveness to limit the number of illness and missed days.(From Day 15 to 3 months)
- Real-life effectiveness to limit the impact on daily life for the family.(From Day 15 to 3 months)
- Real-life effectiveness to limit the impact on daily life for the family .(From Day 15 to 3 months)
- Real-life effectiveness to reduce the intake of concomitant medications during winter and allergy seasons.(From Day 15 to 3 months)
- Real-life effectiveness to reduce the evolution towards more severe form or complications.(From Day 15 to 3 months)
- Real-life effectiveness to reduce the evolution towards more severe form or complications - Extra-nasal symptoms.(From Day 15 to 3 months)
- Real-life effectiveness to reduce the evolution towards more severe form or complications - Eyes symptoms.(From Day 15 to 3 months)
- Real-life effectiveness to reduce the evolution towards more severe form or complications - Complications.(From Day 15 to 3 months)
- Real-life effectiveness to reduce the evolution towards more severe form or complications - Asthma.(From Day 15 to 3 months)
- Real-life effectiveness to reduce the evolution towards more severe form or complications - Asthma episodes.(From Day 15 to 3 months)
- Real-life effectiveness to reduce the evolution towards more severe form or complications - Asthma intensity.(From Day 15 to 3 months)
- Real-life effectiveness to reduce the need for unplanned HCP care during winter and allergy seasons.(From Day 15 to 3 months)
- Real-life effectiveness to reduce the need for unplanned HCP care during winter and allergy seasons - Hospitalizations.(From Day 15 to 3 months)
- Real-life assessment of onset and duration of action and perceived effectiveness of the sprays - Onset.(From Day 15 to Month 3)
- Real-life assessment of onset and duration of action and perceived effectiveness of the sprays - Duration.(From Day 15 to Month 3)
- Real-life assessment of onset and duration of action and perceived effectiveness of the sprays.(From Day 15 to Month 3)
- Real-life assessment of onset and duration of action and perceived effectiveness of the sprays - Allergic rhinitis.(From Day 15 to Month 3)
- Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Posology.(From Day 0 to Month 3)
- Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Moment of use.(From Day 0 to Month 3)
- Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Co-usage with medications.(From Day 0 to Month 3)
- Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Occasion of use.(From Day 15 to Month 3)
- Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Baby nasal aspirator.(From Day 0 to Month 3)
- Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Child autonomy.(From Day 0 to Month 3)
- Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Satisfaction.(From Day 0 to Month 3)
- Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Perceived sensation.(From Day 0 to Month 3)
- Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Perceived effectiveness.(From Day 0 to Month 3)
- Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Practicality.(From Day 0 to Month 3)
- Real-life assessment of satisfaction and willingness to reuse and recommendation of the nasal sprays - Reuse and recommend.(From Day 0 to Month 3)
- Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Educational content.(From Day 0 to Month 3)
- Assessment of the safety and tolerance of the nasal sprays - Tolerance.(From Day 0 to Month 3)
- Assessment of the safety and tolerance of the nasal sprays - Safety.(From Day 0 to Month 3)
研究者
研究点 (32)
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