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临床试验/NCT00492076
NCT00492076已完成4 期

A Randomised, Double-Blind Placebo-Controlled Study Assessing the Short-Term Effect of a Dermatophagoides Pteronyssinus Extract, Quantified in Mass Units, in Subjects With Perennial Mite Induced Asthma

ALK-Abelló A/S2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
45
试验地点
2
主要终点
Reduction in inhaled corticosteroids

研究概览

简要总结

The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.

详细描述

The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Mild/moderate persistent asthma
  • Positive skin prick test or specific IgE to mites
  • Age: 14-55 years old

排除标准

  • Immunotherapy contraindications
  • Allergy to other inhalant allergens
  • Previous immunotherapy (5 years)with mites

结局指标

主要结局

Reduction in inhaled corticosteroids

时间窗: 4 months

次要结局

  • Reduction in symptoms and rescue medication Tolerability(4 months)

研究者

申办方类型
Industry

研究点 (2)

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