NCT06580210招募中不适用
Prospective Multicenter Clinical Investigation to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert (DEMECA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert at 3 days
研究概览
简要总结
The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis,
- •3. a. Informed adult patient who has given written consent prior to any study specific procedure,
- •b. Informed minor patients 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 (questionnaire completion),
- •5. Patient affiliated to a social security scheme.
排除标准
- •1. Patient who does not want to participate to the clinical investigation,
- •2. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray,
- •3. A child with a history of febrile convulsions,
- •4. Diseases leading to respiratory insufficiency,
- •5. Patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction,
- •6. Patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (NSAIDs), antibiotics and local antiseptics,
- •7. Concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel,
- •8. Patient under guardianship, curatorship of safeguard of justice.
结局指标
主要结局
Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert at 3 days
时间窗: From Day 0 to Day 3
Proportion of patients 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 pharmacy before using the spray) and Day 3 (in the evening after the last daily use of the spray). This item is scaled form 0 to 5 and 5 is the worst value.
次要结局
- Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert after the first use(At Day 0)
- Subjective feeling of reduced nasal obstruction on each day of use(From Day 0 and Day 6)
- Subjective feeling of nasal secretion thinning on each day of use(From Day 0 to Day 6)
- Subjective feeling of nasal cavity cleansing (freshness) on each day of use(From Day 0 to Day 6)
- Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use(From Day 0 to Day 6)
- Subjective feeling of relief of nasal itching on each day of use(From Day 0 to Day 6)
- Subjective feeling of nasal cavity cleansing (freshness) immediately (2 minuts) after the use of the spray at Day 0(At Day 0 and Day 6)
- Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 6(At Day 6)
- Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 0(At Day 0)
- Improvement in the patient s quality of life after 7 days of use(At Day 0 et Day 6)
- Patient satisfaction with the spray after 7 days of use(At Day 6)
- Patient s recommendation of the spray after 7 days of use(At Day 6)
- Patient s willingness to continue using the spray at Day 6(At day 6)
- Facility of use of the spray after 7 days of use(At Day 6)
- Evolution of the overall severity of symptoms(At Day 0 and Day 3)
- Sensations of tingling and transient irritation(From Day 0 to Day 6)
- All device deficiencies reported by patients using the spray during the 7 days of use(From Day 0 to Day 6)
- All adverse events reported by patients using the spray during the 7 days of use(From Day 0 to Day 6)
研究者
研究点 (6)
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