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临床试验/NCT02593279
NCT02593279终止不适用

AVAD: Asthma With Small Airways Dysfunction. Clinical, Immunobiological, Tomodensitometric Description, Genetic Signature Compared With Asthmatic Population With Proximal Airways Obstruction

Hospices Civils de Lyon5 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
5
主要终点
mRNA expression levels.

研究概览

简要总结

The aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction.

The objective of this study is also to complete the clinical, immunobiological and morphological analysis of asthma with small airways dysfunction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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

  • man or woman
  • age ≥ 18 years
  • inform consent signed
  • affiliated to health insurance
  • Specific inclusion criteria : asthma with proximal airways obstruction GROUP
  • Maximal Voluntary Ventilation (MMV)<80%
  • MMV / Forced Vital Capacity (FVC)≤70%
  • Carbon Monoxide Transfer Coefficient (KcO)>80%
  • Specific inclusion criteria : asthma with small airways dysfunction GROUP
  • Maximal Voluntary Ventilation (MMV)≥80%
  • MMV / Vital Capacity(VC)>70%
  • Carbon Monoxide Transfer Coefficient (KcO)>80%

排除标准

  • pregnant woman or breastfeeding
  • patient participating to other biomedical research
  • patient who have participated to other biomedical research within the past 3 months
  • patient refusing to sign the inform consent
  • Specific exclusion criteria :
  • Patient who stopped smoking since less than 12 months
  • Pathological state related to obstructive distal airway damage
  • Broncho-pulmonary infectious disease within the past 4 weeks
  • Solid tumor curated by chemotherapy or chest radiotherapy
  • Chronic respiratory disease
  • Asthma exacerbation within the past 3 months
  • Oral or systemic corticotherapy within the past 3 months

研究组 & 干预措施

asthma with proximal or diffuse lung damage

Active Comparator

干预措施: asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements. (Genetic)

asthma with small airway prevailing damage

Experimental

干预措施: asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements. (Genetic)

结局指标

主要结局

mRNA expression levels.

时间窗: maximum 4 weeks after the inclusion visit.

mRNA expression levels will be measured by microarray analysis.

次要结局

  • clinical asthma profile : symptoms(maximum 4 weeks after the inclusion visit.)
  • clinical asthma profile : medical history(maximum 4 weeks after the inclusion visit.)
  • clinical asthma profile : date of start(maximum 4 weeks after the inclusion visit.)
  • clinical asthma profile : date of aggravation(maximum 4 weeks after the inclusion visit.)
  • clinical asthma profile : comorbidities(maximum 4 weeks after the inclusion visit.)
  • clinical asthma profile : increased factors related to asthma.(maximum 4 weeks after the inclusion visit.)
  • biological asthma profile :blood eosinophils(maximum 4 weeks after the inclusion visit.)
  • biological asthma profile : blood periostin(maximum 4 weeks after the inclusion visit.)
  • biological asthma profile : allergologic patch test(maximum 4 weeks after the inclusion visit.)
  • biological asthma profile : IgE analysis(maximum 4 weeks after the inclusion visit.)
  • morphological asthma profile : Chest X Ray (tomodensitometric test).(maximum 4 weeks after the inclusion visit.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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