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

NCT05738044 | Unknown

• 1 other identifier: COPD-BE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation; Bronchiectasis With Acute Exacerbation

Keywords

Chronic Obstructive Pulmonary Disease; Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Day0 and week 10

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

  Day0 and week 10

Study Arms (2)

COPD patients

Patient meets diagnose of COPD refering to "Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2022" will be included.

Other: 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

Interventions

No intervention OTHER

No intervention

Bronchiectasis patients; COPD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200025, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiectasis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases

Central Study Contacts

Jieming Qu

CONTACT

86-021-64370045; jmqu0906@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: February 20, 2023
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-01

Locations

CN (1)