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临床试验/NCT05738044
NCT05738044尚未招募不适用

Multi-omics Analyses of Airway Host-microbiome Interaction in Chronic Obstructive Pulmonary Disease and Bronchiectasis Identify Potential Therapeutic Interventions

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
1
主要终点
Change of lung microbiome in COPD and bronchiectasis patient between exacerbation and clinically stable stage

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) and bronchiectasis are common chronic respiratory diseases in China. COPD is characterized by irreversible lung function decline due to airway inflammation, emphysema and alveolar destruction. Bronchiectasis is characterized by permanent bronchiectasis, its main clinical symptoms are cough, dyspnea, hemoptysis and recurrent respiratory tract infections. The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Airway microbiota, whose alterations play an important role in the occurrence and development of bronchiectasis, form a complex ecosystem interacted with host cells and various biotic and abiotic factors in the microenvironment. Additionally, mounting evidence suggests that the airway microbiome is associated with COPD phenotypes and endotypes, and that dysbiosis contributes to airway inflammation. However, the mechanisms remain poorly understood, owing to limited knowledge of microbial functional properties, metabolic activities and cross-talk with the host immune system. The investigators aim to collect sputum specimen and perform multi-omic analysis on patients with COPD and bronchiectasis in seven clinical centres in China.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis) or COPD (according to GOLD 2022).
  • Patients with age ≥18 years old.
  • Written informed consent.

排除标准

  • Pregnancy or lactation, or those without taking effective contraceptive measures
  • Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders
  • Subjects with a history of alcohol or illicit drug abuse
  • Subjects with any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, acute exacerbation of chronic bronchitis or extremely severe COPD
  • Diagnosis of chronic gastrointestinal disease, heart disease, diabetes, severe renal insufficiency (GFR < 30ml/min) or immunodeficiency
  • Participated in any interventional clinical trial within 3 months before enrolment.
  • Poor compliance or inability to cooperate as judged by the doctor

结局指标

主要结局

Change of lung microbiome in COPD and bronchiectasis patient between exacerbation and clinically stable stage

时间窗: Day0 and week 10

The lung microbiome of COPD and bronchiectasis patients will be defined from sputum samples using traditional bacterial culture and 16S rRNA sequencing.

次要结局

  • Change of lung proteomics in COPD and bronchiectasis patient between exacerbation and clinically stable stage(Day0 and week 10)
  • Change of lung metabolomics in COPD and bronchiectasis patient between exacerbation and clinically stable stage(Day0 and week 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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