Multi-omics Studies of Host-microbiome Interaction in Chronic Obstructive Pulmonary Disease and Bronchiectasis

Not yet recruiting

• Conditions: Bronchiectasis With Acute Exacerbation; COPD Exacerbation
• Interventions: Other: No intervention

• Registration Number: NCT05738044
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-02-09
• Study Start: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2024-03-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bronchiectasis patients	No intervention	Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis)
COPD patients	No intervention	Patient meets diagnose of COPD refering to "Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2022" will be included.

Primary Outcome Measures

Name	Time	Method
Change of lung microbiome in COPD and bronchiectasis patient between exacerbation and clinically stable stage	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.

Secondary Outcome Measures

Name	Time	Method
Change of lung proteomics in COPD and bronchiectasis patient between exacerbation and clinically stable stage	Day0 and week 10	The lung microbiome of COPD and bronchiectasis patients will be defined from sputum samples using Olink multiplex panel.
Change of lung metabolomics in COPD and bronchiectasis patient between exacerbation and clinically stable stage	Day0 and week 10	The lung microbiome of COPD and bronchiectasis patients will be defined from sputum samples using liquid chromatography-mass spectrometry (LC-MS)-based metabolomics approach.

Trial Locations

Locations (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China