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临床试验/NCT03779152
NCT03779152已完成不适用

Regulation of CCL18 by Corticosteroids in Severe Asthma

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Correlation between CCL18 rate and asthma phenotypes by elisa test

研究概览

简要总结

The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • control subjects =
  • non-atopic and non-smoking
  • cutting to negative pneumoallergens,
  • Total IgE levels less than 100 ku / L
  • no clinical history of asthma
  • without background treatment
  • patients with intermittent asthma =
  • being asymptomatic between asthma attacks,
  • with symptoms less than once a week
  • having a forced expiratory volume per second (FEV1) of at least 80% of the theoretical.
  • treated by ß2 mimetics on demand and will not have inhaled corticosteroids.
  • severe asthma insensitive to corticosteroid therapy =
  • continuous or nearly continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)] airway obstruction fixed with FEV1 ranging from less than 15% after 7 days of oral corticosteroid therapy to 40 mg / day of prednisolone;
  • Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.
  • Severe corticosensitive asthma = continuous or near continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)]
  • reversibility of FEV1 after treatment with oral corticosteroids.
  • Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.
  • controlled moderate asthma treated with inhaled corticosteroids <1500μg equivalent of beclomethasone dipropionate and with: ß2 long-acting mimetics (or anti-leukotriene, or theophylline) for at least 6 months.

排除标准

  • existence of a chronic inflammatory pathology other than asthma
  • active smoking
  • pregnant or lactating women
  • have received oral corticosteroid treatment in the previous 3 weeks,
  • have received non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 2 weeks.

结局指标

主要结局

Correlation between CCL18 rate and asthma phenotypes by elisa test

时间窗: Baseline: one session

次要结局

未报告次要终点

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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