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临床试验/NCT04561687
NCT04561687Unknown不适用

Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年1月16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
入组人数
66
试验地点
1
主要终点
Change in Sino-Nasal Outcome Test scores (SNOT-22)

研究概览

简要总结

Comparison of Montelukast and Azelastine In treatment of Allergic Rhinitis Allergic intent is one of the most common diseases of the respiratory system that has a devastating effect on the quality of life. The importance of studying this disease can be seen from the high prevalence of this diseas. In addition to the high prevalence, due to the reducing effect of this disease on the economy and academic performance of patients, a great burden is imposed by this disease on the country's health care system.Also finding the best treatment of allergic can help to control of Asthma if exists concurrently.

Inflammation of the nasal mucosa following the release of IgE can be shown as symptoms of runny nose, sneezing, nasal congestion.Many studies have been done in the field of allergic rhinitis to increase the cost-effectiveness of treatment of this complication. Among the treatments for this disease is the use of antihistamine nasal sprays such as Azelastine. Combination therapies such as combining Mometason furoate or fluticasone with Azelastine or Montelukast can also be mentioned. However, there is still a long way to go to find the best drug combination to reduce the economic and human costs to the global health system. Due to the high prevalence of allergic diseases such as allergic rhinitis, finding the best treatment or management of such diseases plays an important role in improving the quality of life and reducing the economic burden on society.

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 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 6-50years
  • Moderate to severe allergic rhinitis

排除标准

  • Under any treatment
  • Drug sensitivity

研究组 & 干预措施

Azelastine and Nasal Budesonide

Active Comparator

Spray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older

干预措施: Azelastine (Drug)

Azelastine and Nasal Budesonide

Active Comparator

Spray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older

干预措施: Budesonide (Drug)

Montelukast and Nasal budesonide

Active Comparator

Montelukast 5mg 6-14years old and 10mg for older

干预措施: Montelukast (Drug)

Montelukast and Nasal budesonide

Active Comparator

Montelukast 5mg 6-14years old and 10mg for older

干预措施: Budesonide (Drug)

Nasal Budesonide and Placebo

Placebo Comparator

Placebo once daily

干预措施: Budesonide (Drug)

Nasal Budesonide and Placebo

Placebo Comparator

Placebo once daily

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Sino-Nasal Outcome Test scores (SNOT-22)

时间窗: Baseline,month1,month3

Change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be.

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

Nasrin Mortazavi Far

Principal investigator

Shiraz University of Medical Sciences

研究点 (1)

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