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临床试验/NCT03102749
NCT03102749已完成不适用

Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Change in inspiratory:expiratory mean lung density

研究概览

简要总结

New insights of small airway contribution to asthma have been gained. Poor levels of control and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with predominant small airway involvement. Very few pathological specificities were identified at this site: mast cells infiltration was suggested as the specific inflammatory change when compared to the proximal airways.Biomarkers in asthma are still complex to validate, especially in the blood, since compartmentalisation is intense in the lung and the airways, a property attributed to the filtering role of the lung to maintain homeostasis. Over the last few years, Fraction exhaled Nitric Oxide (FENO) was developed as a non-invasive and indirect reflection of airway eosinophilic inflammation]. In the blood, peripheral eosinophil counts were shown as a correct T helper 2 (TH2)-phenotype identifier but not perfectly related to airway eosinophilic infiltration. Club cell secretory protein (SCGB1A1) levels have been shown to have some relevance in asthma, chronic obstructive pulmonary disease (COPD), BOS, sarcoidosis, and lung cancer.A biomarker for small airway disease in asthma may improve the management of the disease, identify areas of therapeutic resistance and constitute a therapeutic guidance tool. In this study, investigators aimed to assess small airway involvement in asthmatic women as far as they could. For this purpose, investigators analysed trends in air trapping by acquiring expiratory CT slices at each dose during a bronchoprovocation test with metacholine. Biomarkers were subsequently tested and confronted to clinical and demographical characteristics in their ability to predict the small airway involvement index obtained at CT.

详细描述

Patients will be recruited in the respiratory department of University Hospital in Montpellier (France) from June 2012 to March 2014. All patients are asthmatics, in order to avoid any gender-related biases, investigators decided to include only women. All participants had normal range spirometry, specifically regarding forced expiratory volume. Each patient will undergo a bronchial provocation test coupled with a thoracic CT scan. Bronchial and alveolar Nitric Oxyde will also be measured, a blood sample will be obtained in order to measure biomarker concentrations, and the patients will be asked to answer the validated Asthma Control Questionnaire in order to quantify asthma control.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female >= 18 yrs
  • Treated with Inhaled Corticosteroid (ICS)
  • normal range spirometry

排除标准

  • Patients with other respiratory disease
  • Patients with myocardial infarction (for 3 month before enrollment)
  • Patients with cerebrovascular accident (for 3 month before enrollment)
  • Patients with arterial aneurysm known
  • Patients in pregnancy
  • Patients nursing

结局指标

主要结局

Change in inspiratory:expiratory mean lung density

时间窗: 4 hours (after the enrollment)

Baseline versus post-methacholine challenge

次要结局

  • FeNO(Baseline)
  • FaNO(Baseline)
  • Change in lung fractal dimension(4 hours (after the enrollment))
  • Bronchial morphometry(Baseline)
  • CC10 level(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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