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

NCT07236541 | Recruiting

• 1 other identifier: B2025-657
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Fibrosis

Outcome Measures

Primary Outcomes (1)

• Clarify the relationship between airway mucus embolism and secondary pulmonary fibrosis in COPD patients

  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.

  At the time of surgery and within 6 months after sample collection for laboratory analysis

Secondary Outcomes (1)

• The correlation between mucus plugs and clinical features

  At the time of surgery and within 6 months after sample collection for laboratory analysis

Study Arms (2)

COPD（chronic hypoxia）

Other: No intervention; observational biospecimen collection only

Normal（Normoxia）

Other: No intervention; observational biospecimen collection only

Interventions

No intervention; observational biospecimen collection only OTHER

No intervention; observational biospecimen collection only

COPD（chronic hypoxia）; Normal（Normoxia）

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients undergoing lung cancer surgery at Zhongshan Hospital, Fudan University. Participants include two groups: (1) patients with chronic obstructive pulmonary disease (COPD), defined by a pre-operative post-bronchodilator FEV₁/FVC \<0.70; and (2) non-COPD surgical controls with normal lung function. During clinically indicated lung cancer resection, distal non-tumorous lung tissue samples and airway mucus (if present) are collected without adding any additional surgical risk. All participants are ≥18 years old and able to provide informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ming Zhong: lead

Study Sites (1)

Zhongshan hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

shengyu hao

CONTACT

18359181031; janet9yu@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician and Professor, Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital, Fudan University

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)