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How to reduce the rapid decline of lung function in patients with AECOPD is a clinically urgent problem to be solved. Studies have suggested that there is a bacterial flora imbalance in the lower respiratory tract of COPD patients. To explore the relationship between microbiology and host immunity is a hot topic in the field of COPD. The investigators use NGS (next generation sequencing) technology to fully explore the specific molecular mechanism of the lower respiratory tract microbiome in patients with COPD by regulating the transcriptional activities of NF-κB and PPARγ in alveolar macrophages, resulting in pulmonary parenchymal remodeling and decreased lung function. In this study, a prospective cohort study will be used to evaluate the effect of the lower respiratory tract microbiome on lung tissue (alveolar space and pulmonary vascular) remodeling and pulmonary function decline in patients with AECOPD.
This study will be based on a prospective cohort design in patients with COPD who are eligible for the study. Fifty patients who met the criteria for inclusion and exclusion of COPD exacerbations and signed informed consent will participate in the study. The purpose of this study is to evaluate the effect of the lower respiratory tract microbiome on lung tissue remodeling, decreased lung function, and clinical symptoms in patients with AECOPD.
Baseline screening includes demographic data, medical history, combined medication records, symptoms, signs, symptom scores, number of acute exacerbations, blood cells and inflammatory factors, electrocardiogram, lung function, alveolar lavage fluid microbe NGS, and safety observation indicators.
Patients will be followed up every 3 months for a period of 1 year. The primary and secondary endpoints are as follows.
Primary endpoint: Changes in FEV1 (forced expiratory volume in the first second) within 1 year of follow-up
Secondary endpoint: Changes in CAT, CCQ, mMRC scores during 1 year of follow-up Changes in lung function during 1 year of follow-up: FEV1 / FVC Changes in blood routine, IgE, and eosinophil count within 1 year of follow-up Number of hospital admissions due to acute exacerbation during 1 year of follow-up
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| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | Forced expiratory volume in the first second | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| CAT scores | COPD Assessment Test score; Score: 0-10, Low impact; Score: 10-20, Moderate impact; Score 20-30, High impact; Score 30-40, Very high impact. | 12 months |
| mMRC scores | The modified British Medical ResearchCouncil (mMRC) questionnaire total score ranges from 0 to 4, with higher grades indicating more severe breathlessness. |
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Inclusion Criteria:
Patients with a diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) according to the GOLD2018 guidelines (patients with FEV1pred> 30% and no concurrent respiratory failure);
Age ≥18, ≤80 years, regardless of gender;
No antibiotics have been used after this acute exacerbation;
Treatment according to GOLD guidelines;
Those with the following bronchoscopy indications:
Voluntary signed informed consent.
Exclusion Criteria:
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Fifty patients who met the criteria for inclusion and exclusion of COPD exacerbations and signed informed consent will participate in the study. Patients will be followed up every 3 months for a period of 1 year.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengqing Li, PhD | Contact | +8602152887072 | shengqingli9655@163.com | |
| Jingwen Xia, MD | Contact | +8602152887072 | xjw2006@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shengqing Li, PhD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan hospital,Fudan university | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Specimens include blood specimens and alveolar lavage fluid, used to detect blood routine, peripheral blood inflammatory factors (IL-8, TNF-α, IL-17), alveolar tube lavage microorganisms, and alveolar lavage fluid inflammatory factors (NF- κB, PPARγ, MMP-12, TIMP-4).
| 12 months |
| other lung function parameters | FEV1/ FVC | 12 months |
| Incidence of COPD exacerbation | Number of Incidence of COPD exacerbation | 12 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |