Effectiveness of Sodium Hyaluronate In Relieving Nasal Symptoms Of Children With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 入组人数
- 101
- 试验地点
- 4
- 主要终点
- Results of "total nasal symptom score" surveys
研究概览
简要总结
Nasal irrigation (NI) is recommended as an add-on therapy in patients with allergic rhinitis (AR). The primary purpose of this study was to evaluate the clinical effectiveness of adding hyaluronic acid (HA) solution and normal saline (NSS) to nasal steroid (NS) therapy as add - on therapy in improving quality of life and reducing nasal symptom scores of children with seasonal AR (SAR) with regards to NS therapy. Our secondary purpose was to demonstrate the effects on eosinophil count in nasal cytology (NEC), nasal airflow (NAF), and resistance (NAR).
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients between 6 to 12-year-old;
- •Children must have a clinical history concordant to seasonal allergic rhinitis of the previous year;
- •Children must have skin prick test (SPT) positivity to pollen (tree, grass, or weed) (Positive SPT is defined as; skin reaction with within 15 minutes after the test and 3 mm larger swelling compared to the negative control test; ALK, Hørsholm, Denmark)
- •Children must have a total nasal symptom score (TNSS) of 4 or more on 4 of 7 days during the run-in period.
排除标准
- •Children who were treated with systemic/topical nasal corticosteroids, antihistamines or antibiotics, leukotriene receptor antagonists 4 weeks before the examination,
- •those who had upper or lower respiratory tract infections;
- •recipients of recent or ongoing allergen immunotherapy;
- •active smokers;
- •those with cystic fibrosis, immunodeficiency, septal deviation, nasal polyps, and ostio-metal complex, exudation, abnormal nasal diagnostic function, nasal anatomical disorder, metabolic disease, or congenital disease.
- •Phone calls will measure children's adherence rate to treatment protocols, and participants determined to have treatment protocol adherence rates below 85% will be excluded.
结局指标
主要结局
Results of "total nasal symptom score" surveys
时间窗: 28 days
The primary outcome will be to understand whether nasal irrigation with hyaluronic acid (HA) solution will be beneficial as add-on therapy in children who are already receiving nasal steroid (NS) therapy. Total Nasal Symptom Scores (TNSS) of all participants (the study and control groups) will be used in grading the symptom relief of seasonal allergic rhinitis. Each symptom (nasal congestion, runny nose, nasal itching, and sneezing) will be graded from 0-3 (0=None, 1=Mild, 2=Moderate, 3=Severe) by the participants during the screening. No special unit for the scoring system is identified according to TNSS (Only scores mentioned with numbers will be analyzed with SPSS, and the percentages of symptoms will be the primary outcome).
Results of "Pediatric rhinoconjunctivitis quality of life questionnaire" survey
时间窗: 28 days
PRQLQ is a self-administered, disease-specific questionnaire and the survey contains 23 items in 5 domains: nose symptoms (RS), eye symptoms (ES), practical problems (PF), activity limitation (RL) and other symptoms (OS). One score is given to each domain. 7-point scale (from 0, not problematic; to 6, very problematic). The overall score will be derived from the average score of all items. No special unit for the scoring system is identified according to PRQLQ (Only scores mentioned with numbers will be analyzed with SPSS, and the percentages of symptoms will be the primary outcome 2).
次要结局
- Nasal resistance (NAR) (Pa. s/ml)(Two days)
- Nasal smear eosinophil count (percentages)(Two days)
- Nasal airflow (NAF) (ccm/sn)(Two days)
研究者
Nazlı ERCAN
Pediatric Allergy and Immunology Specialist
Saglik Bilimleri Universitesi