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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05738044
Enrollment
500
Registered
2023-02-21
Start date
2023-02-20
Completion date
2024-06-30
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis With Acute Exacerbation, COPD Exacerbation

Keywords

Chronic Obstructive Pulmonary Disease, Bronchiectasis

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of lung microbiome in COPD and bronchiectasis patient between exacerbation and clinically stable stageDay0 and week 10The lung microbiome of COPD and bronchiectasis patients will be defined from sputum samples using traditional bacterial culture and 16S rRNA sequencing.

Secondary

MeasureTime frameDescription
Change of lung metabolomics in COPD and bronchiectasis patient between exacerbation and clinically stable stageDay0 and week 10The lung microbiome of COPD and bronchiectasis patients will be defined from sputum samples using liquid chromatography-mass spectrometry (LC-MS)-based metabolomics approach.
Change of lung proteomics in COPD and bronchiectasis patient between exacerbation and clinically stable stageDay0 and week 10The lung microbiome of COPD and bronchiectasis patients will be defined from sputum samples using Olink multiplex panel.

Countries

China

Contacts

Primary ContactJieming Qu
jmqu0906@163.com86-021-64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026