Impact of Airway Mucus Plugs on Secondary Pulmonary Fibrosis in COPD Patients: A Single-Center Case-Control Study

NCT07236541 · tracked via the Priya Life Science China tracker

Sponsor

Ming Zhong

Phase

Observational

Started

2025-10-30

Last updated

2025-11-19

Condition(s) studied

Lung Fibrosis

Investigational drug(s) / intervention(s)

No intervention; observational biospecimen collection only

No intervention; observational biospecimen collection only: No intervention; observational biospecimen collection only

Study summary

Chronic obstructive pulmonary disease (COPD) is frequently accompanied by airway mucus plugs, which are closely associated with airflow obstruction, acute exacerbations, and increased mortality. However, whether mucus plugs contribute to secondary pulmonary fibrosis remains unclear. This single-center, prospective, case-control study aims to investigate the relationship between airway mucus plugs and lung fibrosis in patients with COPD undergoing lung cancer surgery.

During surgery, distal non-tumorous lung tissues and airway mucus will be collected for histological and molecular analyses. Mucus plug burden will be quantified using AB-PAS staining, and fibrosis will be assessed using Masson staining. Expression of epithelial-mesenchymal transition (EMT) markers, fibrotic markers, and the mechanosensitive ion channel Piezo1 will also be measured. COPD patients (FEV₁/FVC \<0.70) will be compared with non-COPD surgical controls.

The study aims to clarify whether mucus plugs are associated with increased fibrosis and to explore the potential involvement of mechanical-signaling pathways, including Piezo1 activation. Findings may provide new clinical and pathological evidence for mucus-induced fibrotic remodeling in COPD and help identify novel therapeutic targets.

Eligibility

Sex

ALL

Min age

18 Years

Max age

89 Years

Healthy volunteers

Inclusion Criteria: * ① Age ≥ 18 years old; * Planned radical resection for lung cancer, with postoperative pathological diagnosis of primary lung cancer; * During surgery, non tumor lung tissue at a distance of ≥ 5 cm from the tumor edge can be obtained; ④ Case group: Preoperative pulmonary function examination confirmed diagnosis of COPD (FEV ₁/FVC\<0.70); ⑤ Control group: Preoperative lung function was normal (FEV ₁/FVC ≥ 0.70), with no history of COPD; ⑥ The subjects are able to understand and sign the informed consent form Exclusion Criteria: * ① Clear presence of other interstitial lung diseases (ILD) or idiopathic pulmonary fibrosis before or during surgery （IPF）、 Fibrosis after pneumoconiosis or tuberculosis; * Active pulmonary infections (such as bacterial pneumonia, fungal infections, active tuberculosis); * Having received neoadjuvant radiotherapy or chemotherapy, which may affect the morphology or molecular results of distal lung tissue; ④ Combined severe immunodeficiency or long-term systemic immunosuppressive therapy (such as glucocorticoids ≥ 20 mg/d, More than 4 weeks); * Merge with other serious systemic diseases (such as advanced heart failure, end-stage renal disease), affecting study compliance or Survival expectation; ⑥ Pregnant or lactating women; ⑦ Refusing to sign the informed consent form or deemed unsuitable by the researcher to participate in the study.

Primary outcome measure(s)

Clarify the relationship between airway mucus embolism and secondary pulmonary fibrosis in COPD patients — At the time of surgery and within 6 months after sample collection for laboratory analysis
By comparing the distal lung tissue of patients undergoing COPD and non COPD lung cancer surgery, a systematic evaluation was conducted to determine the difference between airway mucus thrombus load and the degree of lung tissue fibrosis, and to answer whether airway mucus thrombus is an important pathological factor promoting secondary pulmonary fibrosis in COPD.

Trial sites (1)

Facility	City	Region	Status
Zhongshan hospital	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07236541 on ClinicalTrials.gov ↗ ← All trials in China