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

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05738044
• Other study ID #: COPD-BE
• Status: Not yet recruiting
• Start date: February 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2023
• Source: Ruijin Hospital
• Contact: Jieming Qu
• Phone: 86-021-64370045
• Email: jmqu0906[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis With Acute Exacerbation
• COPD Exacerbation
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Ruijin Hospital, Medical School of Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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