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临床试验/NCT02565212
NCT02565212已完成4 期

Istanbul Gaziosmanpasa Taksim Research and Training Hospital,

Istanbul Training and Research Hospital0 个研究点目标入组 30 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
主要终点
Comparison of the effects of nasal steroids and montelukast on olfactory functions in patients with allergic rhinitis

研究概览

简要总结

The investigators aimed to evaluate by the Sniffin' Sticks test the effects on olfactory functions of nasal steroids and leukotriene antagonists used for allergic rhinitis.Thirty patients with seasonal were included in this study. Patients were randomly divided into three groups of 10 patients; group 1 received montelukast sodium and mometasone furoate therapy, group 2 received only montelukast, and group 3 only mometasone furoate. Patients' olfactory functions were determined using the Sniffin' Sticks olfactory test before and after a month treatments.

Threshold, discrimination, identification, and TDI values were not significantly different among the groups before treatment. For Group 1 and Group 3 patients, there were statistically significant differences in threshold, discrimination, identification, and TDI values before and after treatment (p < 0.05) (Wilcoxon signed ranks analysis) For Group 2 patients, the before and after treatment values of threshold, discrimination, identification, and TDI showed no significant differences (p > 0.05). According to the findings of our study, MF is superior to montelukast in improving olfactory function. Although montelukast has been shown to be effective against AR symptoms, its effect on olfactory function was not demonstrated in this study.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Positive skin test to grass and/or tree pollens in patients with clinical history of seasonal AR for at least 1 year

排除标准

  • Patients who had received drug treatment or immunotherapy before the study were excluded.
  • Patients with asthma, deviated nasal septum, history of nasal operation, turbinate hypertrophy, nasal polyposis or chronic nasal disorders, pregnancy, or upper airway infections were also excluded.

研究组 & 干预措施

Group 2

Active Comparator

montelukast

干预措施: Montelukast,mometazon froat (Drug)

GROUP 1

Experimental

montelukast sodium and mometasone

干预措施: Montelukast,mometazon froat (Drug)

Group 3

Active Comparator

mometasone furoate

干预措施: Montelukast,mometazon froat (Drug)

结局指标

主要结局

Comparison of the effects of nasal steroids and montelukast on olfactory functions in patients with allergic rhinitis

时间窗: 1 month

Sniff'in and Snick test (olfactory Test)

次要结局

未报告次要终点

研究者

发起方
Istanbul Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

dalgic abdullah

Istanbul Gaziosmanpasa Taksim Research and Training Hospital,

Istanbul Training and Research Hospital

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