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临床试验/NCT02773628
NCT02773628终止不适用

Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable Asthma

Centre Hospitalier Universitaire Saint Pierre2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
3
试验地点
2
主要终点
assessment of successful stepdown of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ)

研究概览

简要总结

Eviction methods for dust mite allergy have been evaluated in asthma control in a recent Cochrane meta-analysis. None have shown efficacy on asthma control and there are not recommended. The purpose is to evaluate the efficacy of a new commercialized system (Acar'Up) to decrease dust mite load and to assess its impact on the possibility to perform inhaled corticosteroids step down in stable asthmatics.

详细描述

Eviction methods for dust mite allergy have been evaluated in asthma control in a recent Cochrane meta-analysis. None have shown efficacy on asthma control and there are not recommended. The purpose is to evaluate the efficacy of a new commercialized system, Acar'Up (a spray pulverized on a technical textile that traps the dust mite) to decrease dust mite load and to assess its impact on the possibility to perform inhaled corticosteroids step down in stable asthmatics.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed asthma diagnosis
  • controlled asthma for more than 3 months
  • treatment with inhaled corticosteroids
  • dust mite allergy proved by skin tests ou specific immunoglobulin E

排除标准

  • chronic obstructive pulmonary disease, bronchiectasis, Fibrosis, tuberculosis
  • asthma-chronic obstructive pulmonary disease overlap syndrome
  • ongoing desensitization for dust mite
  • pregnancy
  • previous use of Acar'up

研究组 & 干预措施

control group

Placebo Comparator

stable asthmatics receiving an Acar'up placebo system

干预措施: Acar'up placebo system (Device)

treatment group

Active Comparator

stable asthmatics receiving Acar'up system

干预措施: Acar'up system (Device)

结局指标

主要结局

assessment of successful stepdown of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ)

时间窗: 4 months

assessment of the successful step down of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ)

assessment of successful stepdown of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ)

时间窗: 4 months

assessment of the successful step down of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ)

assessment of successful stepdown of inhaled corticosteroid using clinical evaluation

时间窗: 4 months

assessment of the successful step down of inhaled corticosteroid using clinical evaluation

次要结局

  • assessment of asthma control by the asthma control questionnaire questionnaire(4 months)
  • assessment of rhinitis control by the rhinitis quality of life questionnaire(4 months)
  • assessment of asthma quality of life by the asthma quality of life questionnaire(4 months)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Sponsor

研究点 (2)

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