Study on the Efficacy and Safety of Oral Administration of Arbidol in the Treatment of Allergic Rhinitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The protein level of molecular biomarkers in nasal epithelial cells
研究概览
简要总结
The most important treatment for AR is topical nasal medications (including nasal corticosteroids, nasal antihistamines, nasal decongestants, and nasal saline irrigation etc.), which are still limited. Arbidol may inhibit molecular targets involved in the pathogenesis of AR. This study intends to explore the effect of Arbidol in the treatment of allergic rhinitis and evaluate its efficacy and safety.
详细描述
Allergic rhinitis (AR) is a non-infectious inflammatory disease of the nasal mucosa mediated by Immunoglobulin E after exposure to allergens. AR has become a major chronic inflammatory disease of the respiratory tract, which has a serious impact on the quality of life of patients and social economy. The most important treatment for AR is topical nasal medications (including nasal corticosteroids, nasal antihistamines, nasal decongestants, and nasal saline irrigation etc.). However, even if patients are treated completely according to the standard diagnosis and treatment strategy, a considerable number of patients still do not achieve satisfactory treatment results. Arbidol is a medicine for the prevention and treatment of influenza. Based on our previous laboratory data, Arbidol may inhibit molecular targets involved in the pathogenesis of AR. In order to make the treatment of AR more effective, timely and convenient, this study intends to explore the effect of Arbidol in the treatment of allergic rhinitis and evaluate its efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with allergic rhinitis (in line with the diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015, Tianjin)" formulated by the Rhinology Group of the Otolaryngology-Head and Neck Surgery Branch of the Chinese Medical Association).
- •At least 2 nasal symptoms are moderate or above (referring to sneezing, runny nose, nasal itching, nasal congestion with at least 2 symptoms ≥2 points).
- •Female subjects are not pregnant or lactating and have no pregnancy and lactation plans during the trial medication period.
- •The subject has not participated in other clinical trials in the previous three months and agrees not to participate in other clinical trials before reaching the endpoint of this trial.
- •The subject/legally authorized representative understands the purpose and procedures of the trial and voluntarily signs the informed consent form, voluntarily participates in the study and complies with the study regulations, understands and complies with the medication dosage and follow-up plan, and correctly records the scale score, the number of medications, concomitant medication and adverse event records.
排除标准
- •Who are allergic to Arbidol.
- •Patients with abnormal liver and kidney function (ALT and AST exceed the maximum limit of normal value by 1.5 times, and Cr exceeds the upper limit of normal value).
- •Patients with abnormal ECG parameters and clinically significant (PR>220ms, QRS>120ms, QTc>450ms) and bradycardia.
- •Patients with severe asthma or acute asthma exacerbations.
- •Patients with structural heart disease, severe hypertension (blood pressure greater than 180/110mmHg), diabetes, hyperthyroidism, malignant tumors, immunocompromise, and mental illness. Patients with structural heart disease, severe hypertension (blood pressure greater than 180/110mmHg), diabetes, hyperthyroidism, malignant tumors, immunocompromise, and mental illness.
- •Patients with nasal polyps, severe deviated nasal septum, sinusitis, and hypertrophic rhinitis.
- •Who have participated in other clinical studies within 3 months.
- •Women are pregnant or lactating, in childbearing age with positive blood pregnancy test, or have pregnancy and lactation plans during the trial medication.
- •Drug abuse and alcoholism.
- •Who have received allergen-specific immunotherapy within 3 years.
- •Positive infectious disease screening (hepatitis B surface antigen, hepatitis C antibody, AIDS antibody and treponema pallidum antibody).
- •Who should not be included if there are other reasons in the opinion of the investigator.
研究组 & 干预措施
Arbidol
Arbidol Hydrochloride Tablets
干预措施: Arbidol (Drug)
结局指标
主要结局
The protein level of molecular biomarkers in nasal epithelial cells
时间窗: 14 days
The level of molecular biomarkers in nasal epithelial cells at baseline (day 0, prior to treatment), day 14 will be measured by western blotting.
The mRNA level of inflammation molecular biomarkers in nasal epithelial cells
时间窗: 14 days
The relative mRNA level of inflammatory cytokines (including IL-4, IL-13, CCL11, CCL24, CCL26 etc.) in nasal epithelial cells at baseline (day 0, prior to treatment), day 14 will be measured by Real-time PCR.
The level of inflammation molecular biomarkers in nasal lavage fluid
时间窗: 14 days
Investigate the change of inflammation molecular biomarkers using sample of nasal lavage fluid. Biomarkers including IL-4, IL-13, CCL11, CCL24, CCL26 and IgE etc. in nasal lavage fluid at day 7 day 14 were detected to compare the changes of molecular indices relative to baseline at day 0.
次要结局
- Changes from baseline in daily total nasal symptom score (TNSS) during 2 weeks of treatment.(14 days)
研究者
Zheng Liu
Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Huazhong University of Science and Technology