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Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children (CAVASTHME)

2016年6月17日 更新者:University Hospital, Toulouse

Asthma affects about 10% of children and 6% of adults in industrialized countries. Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are broadly involved in this pathology in experimental models and in humans. Many studies show that the signaling pathways activated by the commitment of T receiver differ depending LT. The identification of specific signaling pathways links to Th2 offer new therapeutic approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium channels sensitive channels Cav1 voltage, normally found in excitable cells where they are defined as receivers dihydropyridine (DHP).

The goal of the present study is to show the presence of Cav1 channels in inflammatory cells in allergic asthmatics and show overexpression of these channels in the peripheral blood mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in comparison with controls.

研究概览

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 18年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

For Asthmatic children arm :

  • Girl not in childbearing potential or taking contraceptive treatment
  • Asthma diagnosis in at least 6 months as defined by clinical symptoms (expiratory dyspnea, wheezing, sibilance) and respiratory function (reversibility of VEMS at least 12% after salbutamol administration)
  • Allergologic tests positives to airborne allergens : positive prick test and/or specific IgE > 0,35 kU/L for at least one allergen
  • Asthma severity between mild to moderate based on Global initiative for asthma classification during more than one month with inhaled corticotherapies +/- long term action beta -mimetic long compounds (salmeterol, formoterol)
  • Patient insured with a social security scheme

For control children arm :

  • Girl not in childbearing potential or taking contraceptive treatment
  • No medical history of asthma
  • No medical history of allergy or symptoms of allergy on skin (atopic dermatitis), respiratory tract (rhino-conjunctivitis, asthma) or food allergy

Exclusion Criteria:

For both arms:

  • Chronic respiratory pathology : known occlusive or restrictive respiratory syndrome like interstitial lung disease, neuromuscular disease, mucoviscidoses, respiratory tract abnormalities with cough, dyspnea or digital hippocratism.
  • History of pulmonary or nose and throat infectious disease during last 4 months
  • Parasitic disease non treated during last 3 months
  • Dyspnea during the inclusion
  • Systemic corticotherapy during the last 3 months before inclusion
  • Immunosuppressive therapy during the last 3 months before inclusion
  • Diabeta
  • Disease causing immune disorder
  • Infection during inclusion
  • Participation to another study witch implies medical treatment during last 3 months before inclusion

For asthmatic children arm :

  • Chronic pulmonary pathology (excluding asthma)
  • Asthma exacerbation during inclusion
  • VEMS < 70% of normal range or VEMS < 70% of normal range after inhalation of serum (despite salbutamol administration)
  • Patient unable to complete pulmonary function testing

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Asthmatic children
Induced sputum method using hypertonic serum
Collection of expectoration in sterile vial, conserved in ice all along the examination
假比较器:Control children
Induced sputum method using hypertonic serum
Collection of expectoration in sterile vial, conserved in ice all along the examination

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction
大体时间:Day 1
Day 1

次要结果测量

结果测量
大体时间
Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection
大体时间:Day 1
Day 1
Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection
大体时间:Day 1
Day 1
Comparison of CRTH2+ cells in total blood between asthmatic and control group
大体时间:Day 1
Day 1
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation
大体时间:Day 1
Day 1
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation
大体时间:Day 1
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:François Brémont, MD、Hôpital des Enfants CHU Toulouse

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年3月1日

初级完成 (实际的)

2016年5月1日

研究完成 (实际的)

2016年5月1日

研究注册日期

首次提交

2016年5月17日

首先提交符合 QC 标准的

2016年6月17日

首次发布 (估计)

2016年6月22日

研究记录更新

最后更新发布 (估计)

2016年6月22日

上次提交的符合 QC 标准的更新

2016年6月17日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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