Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With Allergic Rhinitis. RinASol- Pilot Study (Allergic Rhinitis Solution)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Symptom score assessment
研究概览
简要总结
The main objective of RinASol project is to assess in patients with seasonal Allergic Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation by means of nasal cytology.
The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom Score 5)
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
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of Allergic Rhinitis (for at least 1 year)
- •6 years old ≤ children age ≤ 14 years old
- •Total Symptom Score 5: >5 in the last 4 days before screening. Exclusion Criteria
- •Signs of acute infections of upper and lower respiratory tract.
- •Metabolic, immunological, systemic diseases
- •Respiratory tract deformity
- •Systemic/Topical therapies with antibiotics or corticosteroids in the previous 30 days.
- •Active smoker.
排除标准
- 未提供
研究组 & 干预措施
Case
Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3)
干预措施: hypertonic saline solution (NACL 3%+NAHCO3) (Drug)
Control
Allergic Rhinitis Children treated with saline solution (NACL 0,9%)
干预措施: Saline Solution (NACL 0,9%) (Other)
结局指标
主要结局
Symptom score assessment
时间窗: 28 days
The main objective is to evaluate the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on the symptom score assessed by T5SS Questionnaire (Total Symptom Score 5)
次要结局
- Nasal cytology pattern(28 days)
研究者
Stefania La Grutta, MD
Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Istituto per la Ricerca e l'Innovazione Biomedica