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临床试验/NCT06709092
NCT06709092招募中不适用

Study on the Effect and Mechanism of Lupatadine Fumarate in the Treatment of Allergic Rhinitis

Cheng Lei1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Rhinoconjunctivitis Quality of Life Questionnaire

研究概览

简要总结

In China, the prevalence of allergic rhinitis reaches 17.6% and is increasing year by year, seriously affecting the quality of life of patients. Some patients still cannot be effectively treated. So it is urgent to study the pathogenesis of AR and find new therapeutic targets. Lupatadine fumarate has the dual effects of antihistamine and platelet-activating factor (PAF), and it is the only potent and highly effective allergy drug with both antihistamine and PAF antagonism currently on the marke. The exact mechanism of Lupatadine fumarate in relieving nasal congestion in patients with AR is unknown. Tight junction proteins (TJs) play an important role in maintaining endothelial barrier function, and TJ disruption disrupts barrier function and promotes inflammation. 15-LOX(15-lipoxygenase) disrupts tight junctions at the blood-brain barrier. It increases cerebral vascular permeability and contributes to cerebral edema. In a mouse model of atherosclerosis, 15(S)-HETE, the major metabolite of 15-LOX, enhances the phosphorylation of ZO-2 at the Thr-1/1 residue through MEK1-ERK770/772 activation, leading to the dissociation of ZO-1 from occludin and disrupting the endothelial TJ and its barrier function. So we want to study the effects and mechanisms of lupatadine fumarate in the treatment of allergic rhinitis (AR) and whether lupatadine fumarate is directly related to 15-LO1.

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

入选标准

  • Adult patients (18-65 years).
  • Patients with allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).

排除标准

  • Received glucocorticoids, immunomodulatory, antihistamine drugs, and other medications that may affect the study results within the last 1 month.
  • Nasal diseases such as upper respiratory tract infections, chronic sinusitis with or without nasal polyps, and nasal sinus tumors.
  • History of nasal sinus surgery.
  • With other immune and allergic diseases.
  • Patients with a combination of severe cardiac, cerebrovascular or pulmonary - diseases, aspirin triad, primary ciliary dyskinesia, immune deficiency, and coagulation disorders.
  • Pregnant women.

研究组 & 干预措施

Allergic rhinitis

Experimental

For patients with AR, patients were given lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals) 1 tablet once daily at bedtime for 14 days.

干预措施: lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals) (Drug)

结局指标

主要结局

Rhinoconjunctivitis Quality of Life Questionnaire

时间窗: baseline and 14 days

To measure the functional impairments that are most troublesome to adult patients as a result of their rhinoconjunctivitis. Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. 7-point scale (0 = not impaired at all - 6 = severely impaired). Higher scores reflect lower quality of life.

Visual analogue scale

时间窗: baseline and 14 days

Results VAS are well validated for the measurement of AR symptoms and correlate well with the ARIA (allergic rhinitis and its impact on asthma) severity classification. 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.

The concentration of interleukin 4(IL-4), interleukin 5(IL-5), interleukin 13(IL-13)

时间窗: baseline and 14 days

It reflects Th2 immune response in patients with allergic rhinitis

次要结局

未报告次要终点

研究者

发起方
Cheng Lei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cheng Lei

chief physician

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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