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Exploratory study on potential biomarkers in BALF of COPD patients

Exploratory study on potential biomarkers in BALF of COPD patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106569
Enrollment
Unknown
Registered
2025-07-25
Start date
2024-11-06
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

COPD

Interventions

Healthy control group:None

Sponsors

The Central Hospital of Wuhan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for COPD patients: (1) 40-80 years old (including upper and lower limits), male or female; (2) Currently smoking, or having never smoked, or a smoker (who has quit smoking for more than 6 months at the time of screening and has a smoking history of 10 packs per year or more); (3) According to the GOLD (Global Initiative for Chronic Obstructive Pulmonary Disease) guidelines, subjects diagnosed with COPD for more than 12 months prior to screening; (4) Before screening, the FEVI of subjects using bronchodilators accounted for = 30% of the expected value (GOLD I-II). 2. Inclusion criteria for healthy control population: (1) Age range of 40-80 years old; (2) Subjects undergoing elective surgery, such as hernia repair, plastic surgery, benign skin mass resection, etc; Perform lung function before surgery Ability to perform lung CT, electrocardiogram, whole blood cell count, and biochemical analysis; (3) Four weeks prior to inclusion in the study, there were no respiratory symptoms such as fever, runny nose, nasal congestion, cough, sputum production, wheezing, chest pain, etc Hemoptysis, etc; (4) There were no clinical infections in the three months prior to inclusion in the study; Have not used oral/nasal antibiotics/antifungal drugs/antiviral drugs in the past 3 months Toxic drugs; (5) Research participants or their family members voluntarily participate and sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1.Exclusion criteria for COPD patients: (1) Pregnant or breastfeeding; (2) Having undergone lung resection/lung volume reduction/lung transplantation surgery within the previous year prior to screening; (3) Respiratory infections occurred within the first 4 weeks of screening, or antibiotics, systemic corticosteroids, and theophylline were used; (4) Severe liver/kidney dysfunction; (5) History of immunodeficiency (congenital immunodeficiency, HIV infection, etc.); (6) The subject experienced acute exacerbation of COPD within 4 weeks prior to screening; (7) Those who have participated in other clinical trials within the previous 3 months before screening, or are still within the safety washout period (<5 half lives) specified in the previous drug clinical trial before screening, whichever is longer; (8) Suffering from malignant tumors within 5 years; (9) Previous pulmonary abnormalities/diseases with significant clinical significance other than COPD (active sarcoidosis, bronchiectasis, pulmonary fibrosis, interstitial pneumonia, etc.). 2.Exclusion criteria for healthy control population Patients who meet any of the following criteria will not be eligible for this study: (1) Have a history of smoking; (2) Suffering from severe periodontal disease diagnosed by a dental specialist; (3) After nasal cavity surgery (53 months), patients with external cavity tumors and severe deformities; (4) Subjects with persistent bronchial asthma, severe pulmonary dysfunction, or inability to tolerate bronchoscopy examination; (5) Abnormal lung CT examination: cystic fibrosis, clinically significant bronchiectasis, fibrotic lung disease or other Chronic lung disease; (6) Suffering from gastroesophageal reflux disease and peptic ulcer; Take probiotics within 6 months; (7) Patients with obvious bleeding tendency, severe pulmonary hypertension, superior vena cava obstruction, and risk of aortic aneurysm rupture; (8) Patients with malignant hypertension, recent myocardial infarction (= 6 months), severe arrhythmia, and cardiac dysfunction; (9) Suffering from diabetes, autoimmune disease, malignant tumor disease, congenital or acquired immunodeficiency disease, others Systemic inflammatory response diseases; (10) Individuals undergoing high-risk immunosuppressive/cellular garlic drug therapy, such as rituximab, avidin, or steroids Continuous use of hormones for more than 4 weeks; (11) Pregnancy or lactation period; (12) Having impaired mental function or active mental illness that hinders informed consent; (13) Other clinical physicians determine that the candidate is not suitable for the study Pregnant women or currently breastfeeding.

Design outcomes

Primary

MeasureTime frame
Biomarkers in bronchoalveolar lavage fluid;Hemolytic phosphatidylcholine detection;Protein quantification of alveolar lavage fluid supernatant;

Countries

China

Contacts

Public ContactShuang Geng

The Central Hospital of Wuhan

gengshuangsky@126.com+86 27 65699802

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026