Microbial Characterization in Patients With Allergic Rhinitis Before and After Sublingual Immunotherapy Spray
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
研究概览
简要总结
The incidence of allergic rhinitis (AR) in Chinese adults was reported to be as high as 24.1% and 16.8% in children. The current symptomatic treatment has the disadvantage of poor efficacy and cannot change the natural course of the disease. Allergen immunotherapy (AIT) is the only causative treatment approved by the WHO, bringing a new option to patients with allergic diseases. The quality of allergen preparations is critical to the diagnosis and treatment of the disease, emphasizing the need for standardized preparations, and AIT treatment in the early stages of the disease may change the long-term progression of the disease. Recent studies have reported that the microbiome of patients with different efficacy of desensitization therapy is different and may be correlated with the clinical symptoms of patients, but no prospective studies have been reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-65 years).
- •Patients with canis familiari/felis domesticus/alternaria alternata allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).
- •Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual spray desensitization.
排除标准
- •Patients who refused to accept specimen and questionnaire collection.
- •Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
研究组 & 干预措施
Patients desensitized by sublingual spray
Oraltekzc®️(Canis familiari), Oraltek®️(Felis domesticus), Oraltek®️(Alternaria alternata), dosage form: sublingual spray.
干预措施: Patients desensitized by sublingual spray (Drug)
结局指标
主要结局
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
时间窗: 2024.2-2026.7
Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure
Visual analogue scale (VAS)
时间窗: 2024.2-2026.7
Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. Range: 0-10. Higher scores reflect more pain and severity.
Total Nasal Symptom Score (TNSS)
时间窗: 2024.2-2026.7
It includes four common nasal symptoms: itching, nasal congestion, sneezing and runny nose. These four symptoms are scored using a "four-point scale," in which the severity of each symptom is rated from 0 to 3. The total score for the entire TNSS score is the sum of the four symptom scores, which range from 0 to 12.
次要结局
未报告次要终点