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临床试验/NCT03592212
NCT03592212进行中(未招募)不适用

Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2018年11月25日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
99
试验地点
2
主要终点
pre- and post-bronchodilator VEMS value

研究概览

简要总结

This study is designed to investigate whether the Phosphodiesterase 4 gene variability could be implicated in the salbutamol responsiveness in asthmatic children.

详细描述

Patients from 6 to 18 years old with asthma and receiving a treatment by salbutamol according to the usual care will be recruited. Saliva from patients will be collected using Oragen®.DNA OG-575 kit.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children 6-18 years
  • Asthma: confirmed asthma symptoms (wheeze, cough, dyspnea, chest tightness) and evidence for variable airflow limitation (≥ 12% increase in post bronchodilator FEV1, or ≥ 20% decrease in FEV1 post methacholine)
  • Spirometry prescribed for follow-up
  • Airflow limitation: FEV1<80% and/or FEV1/FVC <80 pre-bronchodilator

排除标准

  • no exclusion criteria

结局指标

主要结局

pre- and post-bronchodilator VEMS value

时间窗: Day 0

comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator VEMS value (BDR = 100 x \[post-VEMS - pre-VEMS\]/pre-VEMS) according to the genotype of the rs1504982

次要结局

  • Screening other SNPs (other genes than PDE4) associated with the response to salbutamol in childhood asthma using SNP tags(Day 0)
  • Locating other regions of the PDE4 gene that may be associated with the response to salbutamol by gene mapping (using SNP tags)(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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