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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD Exacerbation; Bronchiectasis With Acute Exacerbation
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Jieming Qu; Phone Number: 86-021-64370045; Email: jmqu0906@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Medical School of Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients enrolled in this study should meet the bronchiectasis diagnositc criteria according to the Chinese consensus or COPD diagnositc criteria according to GOLD 2022.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of lung microbiome in COPD and bronchiectasis patient between exacerbation and clinically stable stage	The lung microbiome of COPD and bronchiectasis patients will be defined from sputum samples using traditional bacterial culture and 16S rRNA sequencing.	Day0 and week 10

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2023
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Estimate): February 21, 2023

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Bronchiectasis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: COPD-BE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No