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临床试验/NCT02561390
NCT02561390已完成不适用

In-vivo Potency Evaluation of American Cockroach, Dog, Cat, Dust Mites and Mold Allergen Extracts Produced by Siriraj Hospital Comparing With Imported Extracts by Using Skin Prick Test.

Mahidol University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels

研究概览

简要总结

The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC found that prevalence of AR and asthma inThailand was in moderately high group.

Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of allergen in patient. They guided the investigators for proper management as well as patient education. Clinician will use the result for choose allergen in case that might need immunotherapy.

SPT is safe and more economic for patient. Specific IgE has an advantage in patient who cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two tests. In Thailand, the investigators haven't had data about it yet.

详细描述

SPT and specific IgE for allergens is necessary for allergen avoidance and specific immunotherapy. To have local allergen extracts will help the patients to easier get the appropriate management

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
10 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with controlled Asthma and/or AR (mild to moderate severity) who were diagnosed in Allergy clinic and ENT clinic, Siriraj hospital
  • SPT positve one of American Cockroach, House dust mite, cat, dog and mold.
  • Patient were consented to trial.

排除标准

  • Chronic disease such as heart disease, liver, renal and severe sepsis
  • History of anaphylaxis
  • Skin rash
  • Pregnancy

结局指标

主要结局

mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels

时间窗: 18 months

measure and compare SPT result of local and imported allergen extracts

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

Nualanong Visitsunthorn

Prof

Mahidol University

研究点 (2)

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