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临床试验/NCT05381207
NCT05381207尚未招募早期 1 期

Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers

Assiut University0 个研究点目标入组 60 人开始时间: 2022年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
60
主要终点
Nasal symptoms

研究概览

简要总结

To examine the efficacy of Montelukast as an adjunct to INCS in patients with allergic rhinitis.

详细描述

Allergic rhinitis (AR) is a non-infectious inflammatory disease occurring in nasal mucosa with nasal itching, nasal congestion, rhinorrhea, and sneezing as its main clinical symptoms, which are induced by immunoglobulin E-mediated chemical mediators with the participation of various immunologically competent cells and cytokines after allergen exposure. (1) According to statistics, AR affects 10% to 25% of the global population. (2).

AR could be investigated by skin prick test, A blood test to check for the immunoglobulin E (IgE) antibody, and Total blood eosinophil count. (3) Current guidelines suggest that Intranasal corticosteroids should be used as the first line of treatment (4).

Surgical care may be indicated for comorbid or complicating conditions such as chronic sinusitis and nasal polyps. (5) Many studies have proven that the abnormality of inflammatory factors such as(TNF-α, IL-6, and IL-12)are closely related to the pathogenesis of AR. (6)these inflammatory factors participate in the regulation of immune response through media leucocyte chemotaxis and activate, so elevate of levels of these 3 factors can reflect the aggravation of inflammatory markers in the patient with AR. (7) Montelukast is belonging to the leukotriene receptor antagonists with the effect of inhibiting the expression of cysteinyl leukotriene involved in the pathogen of AR. Thus, the inhibition of the inflammatory marker can effectively reduce airway inflammatory response, nasal mucosal edema, and inflammatory exudation etiologically [8].

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (aged 18 years and over) with AR. Clinical diagnosis of Allergic Rhinits Must be able to swallow tablets

排除标准

  • Bronchial Asthma patients. Patients already on Antihistamine combined treatment Patients who are allergic to this medication Advanced liver or kidney diseases.

研究组 & 干预措施

Montelukast

Active Comparator

Montelukast, 10 mg, oraly Local corticosteriod nasal spary

干预措施: Montelukast Oral Tablet (Drug)

结局指标

主要结局

Nasal symptoms

时间窗: 3 monthes

Participants will be asked to score five Sino-nasal symptoms (nasal congestion/obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of smell, and facial pain) from 0 to 4. This score will be assessed at the screening and follow-up visits at 12 weeks. The total five-symptom score (T5SS) was obtained with the sum of the individual symptoms (0-20).

laboratory findings

时间窗: 3 months

Evaluation of inflammatory markers levels (TNF-α, IL-6, IL-12) in inpatient blood At 0 point premedication (pre-medication) At 1 point post medication after 12 weeks (3 months)

Quality of life symptoms

时间窗: 3 monthes

Subjects will complete a validated questionnaire related to the general quality of life in patients with allergic rhinitis; this questionnaire records patients' symptoms The patients receive a rhino-conjunctivitis quality of life questionnaire. This questionnaire records domains like patient activities, sleep, ......and emotional problems on an 0-x ordinal scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hadeer Ashraf Farouk

Principal Investigator

Assiut University

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