跳至主要内容
临床试验/NCT05437198
NCT05437198招募中不适用

Study of Microbiological Diversity in Exhaled Air in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Subjects Free of COPD

Centre Hospitalier Intercommunal Creteil2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年3月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
2
主要终点
Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects

研究概览

简要总结

COPD and non-COPD patients will be included in the study after collection of their non-objection. The exhalation will be collected to study the microbiological diversity of human exhalations.

a second collection for the year +1 will be made, at the same time (between October and March).

详细描述

The subjects will be recruited during a medical visit in the Departments of Pneumology and Occupational and Environmental Pathologies.

After information and inclusion of the subject in the study, a collection of clinical data, the state of health and the smoking status of the subject will be carried out by the clinical study technician.

A collection of the exhalation will also be carried out by the clinical study technician.

Several groups of subjects will be formed according to pathologies (COPD versus non-COPD), age and smoking status

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with chronic obstructive pulmonary disease
  • Age: over 18
  • For non-COPD
  • Absence of chronic obstructive pulmonary disease
  • Age: between 18 and 30 years old and between 45 and 70 years old

排除标准

  • Taking certain medications in the month preceding the sample (antibiotics, systemic corticosteroids, immunosuppressants)
  • Person under guardianship or curatorship
  • Pregnant or breastfeeding women
  • Person unable to express his/her opposition, person deprived of liberty
  • Existence of a chronic infectious pulmonary pathology such as (dilation of the bronchi, cystic fibrosis)

研究组 & 干预措施

Chronic Obstructive Pulmonary Disease (COPD)

Patients with chronic obstructive pulmonary disease will be recruited from the pulmonology or occupational pathology department. They are either active smokers or ex-smokers. They are over 18 years old

干预措施: collection of human exhalation (Other)

NO-Chronic Obstructive Pulmonary Disease

The no-COPD are controls followed in chi créteil for another pathology. They are between 18 and 30 years old and 45 and 70 years old.

They are either:

  • Ex-smoker
  • Active smoker
  • Non-smoker

干预措施: collection of human exhalation (Other)

结局指标

主要结局

Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects

时间窗: Baseline

number and bacterial species

次要结局

  • Number and dominant bacterial species in human exhalations according to age(Baseline)
  • Number and dominant bacterial species in human exhalations for patients returning for consultation 1 year apart during the winter season(1 year)
  • Number and dominant bacterial species in human exhalations according to smoking status(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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