ReNIM Study - Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing Nasal Interleukin-5 (IL-5) Measurements in Children With Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Nasal Interleukin-17 (IL-17)
研究概览
简要总结
Single-center, randomized, placebo-controlled study to:
- characterize the subjects at baseline and discriminate groups of children based on IL-5, IL-17, IL-23 and INF-γ;
- investigate the effect of Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) for nostril three times/day for 4 weeks, in comparison with placebo, in reducing nasal interleukin-5 (IL-5) in children with Allergic Rhinitis (AR).
Secondary objectives are to examine the effect of resveratrol plus carboxymethyl-β-glucan, in comparison with placebo, on subjective parameters, i.e. symptom scores, visual analogue scales for rhinitis, quality of life and quality of sleep, and the effect on objective parameters, i.e. nasal nitric oxide (nNO) levels, nasal cytology and acoustic rhinometry.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of AR in the previous year;
- •positive skin prick test to seasonal allergens.
排除标准
- •acute upper respiratory infections in the last 4 weeks;
- •lifetime history of asthma (doctor diagnosis);
- •use of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines in the last 4 weeks;
- •anatomic nasal defects (ie, septum deviation), or nasal polyps;
- •active smoker.
研究组 & 干预措施
Resveratrol plus Carboxymethyl-β-Glucan
干预措施: Resveratrol plus Carboxymethyl-β-Glucan (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Nasal Interleukin-17 (IL-17)
时间窗: Baseline
IL-17 level at baseline
Nasal Interleukin-23 (IL-23)
时间窗: Baseline
IL-23 level at baseline
Nasal Interferon-γ (INF-γ)
时间窗: Baseline
INF-γ level at baseline
Nasal PH
时间窗: Baseline
Nasal PH at baseline
Nasal Interleukin-5 (IL-5)
时间窗: Baseline and 28 days
Mean change in IL-5 level from baseline to the end of treatment.
次要结局
- Total 5 Symptom Score (T5SS)(Baseline and 28 days)
- Visual Analogue Scale for Rhinitis (VAS)(Baseline and 28 days)
- Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)(Baseline and 28 days)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline and 28 days)
- Nasal Exhaled Nitric Oxide (nNO)(Baseline and 28 days)
- Nasal Cytology(Baseline and 28 days)
- Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)(Baseline and 28 days)
- Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5)(Baseline and 28 days)
研究者
Stefania La Grutta, MD
Ph.D. 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