NCT05494346招募中不适用
Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 101
- 试验地点
- 10
- 主要终点
- Performance of the Gilbert Laboratories pocket valve spray.
研究概览
简要总结
The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patient ≥ 12 years.
- •2. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
- •3. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.
- •4. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
- •5. Patient affiliated to a social security scheme.
排除标准
- •1. Pregnant and/or breastfeeding woman
- •2. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray.
- •3. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency.
- •4. Patients with uncontrolled asthma (GINA score greater than or equal to 4)
- •5. Patients undergoing allergy desensitization
- •6. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.
- •7. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.
- •8. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose.
- •9. Patients under guardianship, conservatorship, or legal protection.
结局指标
主要结局
Performance of the Gilbert Laboratories pocket valve spray.
时间窗: From Day 0 to Day 3
Proportion of patient presenting a change of the symptom "nasal obstruction" by at least 1 pt, in the SNOT22 Test (item 22), between Day 0 (at inclusion in the office before use of the spray) and Day 3 (in the evening after last daily use of the spray). This item is scaled from 0 to 5, 5 being the worst value.
次要结局
- Improvement in the patient's quality of life after 7 days of use (arms A+B).(From Day 0 to Day 6)
- Patient satisfaction with the medical device after 7 days of use (arm A+B).(At Day 6)
- Subjective feeling of nasal secretion thinning on each day of use (arms A+B).(From Day 0 to Day 6)
- Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B).(From Day 0 to Day 6)
- Subjective feeling of relief of nasal itching on each day of use (arms A+B).(From Day 0 to Day 6)
- Speed of action at which the patient feels (subjectively) a decrease in nasal obstruction at D0 and D3 (arms A+B).(At Day 0 and Day 3)
- Speed of action at which the patient feels (subjectively) a purification of his nasal cavities (sensation of freshness) at D0 and D3 (arms A+B).(At Day 0 and Day 3)
- Facility of use of the medical device after 7 days of use (arm A+B)(At Day 6)
- Evolution of the overall severity of symptoms (arm A+B).(At Day 0 and Day 3)
- All adverse events reported by patients using the pocket valve spray after 7 days of use (arm A+B).(From Day 0 to Day 7)
- Sensations of tingling and transient irritation (arms A+B).(From Day 0 to Day 6)
- Immediate change of nasale obstruction at D0 on first use (Arm A)(At Day 0)
- Subjective feeling of reduced nasal obstruction on each day of use (arms A+B).(From Day 0 to Day 6)
- Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).(From Day 0 to Day 6)
- Change of nasal obstruction between Day 0 and Day 3(From Day 0 to Day 3)
- Immediate change of nasale obstruction at D0 on first use (Arm A)(At Day 0)
- Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B).(From Day 0 to Day 6)
- Speed of action at which the patient feels (subjectively) a decrease in nasal obstruction at D0 and D3 (arms A+B).(At Day 0 and Day 3)
- Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).(From Day 0 to Day 6)
- Sensations of tingling and transient irritation (arms A+B).(From Day 0 to Day 6)
- Facility of use of the medical device after 7 days of use (arm A+B)(At Day 6)
- All adverse events reported by patients using the pocket valve spray after 7 days of use (arm A+B).(From Day 0 to Day 7)
- Change of nasal obstruction between Day 0 and Day 3(From Day 0 to Day 3)
- Subjective feeling of reduced nasal obstruction on each day of use (arms A+B).(From Day 0 to Day 6)
- Subjective feeling of nasal secretion thinning on each day of use (arms A+B).(From Day 0 to Day 6)
- Subjective feeling of relief of nasal itching on each day of use (arms A+B).(From Day 0 to Day 6)
- Speed of action at which the patient feels (subjectively) a purification of his nasal cavities (sensation of freshness) at D0 and D3 (arms A+B).(At Day 0 and Day 3)
- Evolution of the overall severity of symptoms (arm A+B).(At Day 0 and Day 3)
- Improvement in the patient's quality of life after 7 days of use (arms A+B).(From Day 0 to Day 6)
- Patient satisfaction with the medical device after 7 days of use (arm A+B).(At Day 6)
研究者
研究点 (10)
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